<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03783442</url>
  </required_header>
  <id_info>
    <org_study_id>BGB-A317-306</org_study_id>
    <secondary_id>2018-000587-28</secondary_id>
    <secondary_id>CTR20181013</secondary_id>
    <secondary_id>JapicCTI-194741</secondary_id>
    <nct_id>NCT03783442</nct_id>
  </id_info>
  <brief_title>A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma</brief_title>
  <official_title>A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BeiGene</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BeiGene</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of Tislelizumab as first&#xD;
      line treatment in combination with chemotherapy in participants with advanced&#xD;
      unresectable/metastatic esophageal squamous cell carcinoma (ESCC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 11, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to approximately 40 months from date of the first participant randomization</time_frame>
    <description>OS is defined as the time from the date of randomization until the date of death due to any cause</description>
  </primary_outcome>
  <other_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Approximately 40 months from date of the first participant randomization</time_frame>
    <description>PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first</description>
  </other_outcome>
  <other_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Approximately 40 months from date of the first participant randomization</time_frame>
    <description>ORR is defined as the proportion of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by the investigator per RECIST v1.1</description>
  </other_outcome>
  <other_outcome>
    <measure>Overall survival (OS) in the PD-L1 score ≥ 10% subgroup</measure>
    <time_frame>Approximately 40 months from date of the first participant randomization</time_frame>
    <description>OS is defined as the time from the date of randomization until the date of death due to any cause</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Approximately 40 months from date of the first participant randomization</time_frame>
    <description>DOR is defined as the time from the first determination of an objective response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever comes first</description>
  </other_outcome>
  <other_outcome>
    <measure>Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30)</measure>
    <time_frame>Approximately 40 months from date of the first participant randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer specific module (EORTC QLQ-OES18)</measure>
    <time_frame>Approximately 40 months from date of the first participant randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using the generic health state instrument European Quality of Life-5 Dimensions (EuroQol 5D EQ-5D-5L)</measure>
    <time_frame>Approximately 40 months from date of the first participant randomization</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants experiencing Adverse Events (AEs)</measure>
    <time_frame>Approximately 40 months from date of the first participant randomization</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">649</enrollment>
  <condition>Esophageal Squamous Cell Carcinoma (ESCC)</condition>
  <arm_group>
    <arm_group_label>Tislelizumab + chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tislelizumab administered with chemotherapy doublet:&#xD;
Doublet A: Cisplatin or Oxaliplatin plus Fluorouracil (5-FU); Doublet B: Cisplatin or Oxaliplatin plus Capecitabine; Doublet C: Cisplatin or Oxaliplatin plus Paclitaxel</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Placebo administered with chemotherapy doublet:&#xD;
Doublet A: Cisplatin or Oxaliplatin plus Fluorouracil (5-FU); Doublet B: Cisplatin or Oxaliplatin plus Capecitabine; Doublet C: Cisplatin or Oxaliplatin plus Paclitaxel</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>60 to 80 mg/m^2 intravenously (IV) on Day 1 once every 3 weeks (Q3W)</description>
    <arm_group_label>Placebo + chemotherapy</arm_group_label>
    <arm_group_label>Tislelizumab + chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>130 mg/m^2 IV on Day 1 Q3W</description>
    <arm_group_label>Placebo + chemotherapy</arm_group_label>
    <arm_group_label>Tislelizumab + chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluorouracil (5-FU)</intervention_name>
    <description>750 to 800 mg/m^2 IV continuous infusion over 24 hours daily on Days 1 to 5 Q3W</description>
    <arm_group_label>Placebo + chemotherapy</arm_group_label>
    <arm_group_label>Tislelizumab + chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>1000 mg/m^2 orally (PO) twice daily (BID) on Days 1 to 14 Q3W</description>
    <arm_group_label>Placebo + chemotherapy</arm_group_label>
    <arm_group_label>Tislelizumab + chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>175 mg/m^2 IV on Day 1 Q3W</description>
    <arm_group_label>Placebo + chemotherapy</arm_group_label>
    <arm_group_label>Tislelizumab + chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tislelizumab</intervention_name>
    <description>200 mg IV Q3W</description>
    <arm_group_label>Tislelizumab + chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo to match Tislelizumab</description>
    <arm_group_label>Placebo + chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Participants with unresectable, locally advanced recurrent or metastatic ESCC who have&#xD;
        Stage IV unresectable ESCC at first diagnosis (ie, Stage IV disease at the original&#xD;
        diagnosis of ESCC) or who have unresectable, locally advanced recurrent or metastatic&#xD;
        disease with at least a 6-month treatment-free interval, if prior definitive therapy&#xD;
        (chemotherapy, chemo-radiation therapy or surgery) was given.&#xD;
&#xD;
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Pathologically (histologically) confirmed diagnosis of ESCC&#xD;
&#xD;
          2. Stage IV unresectable ESCC at first diagnosis OR unresectable, locally advanced&#xD;
             recurrent or metastatic disease (per American Joint Committee on Cancer 7th Edition),&#xD;
             if there is prior neoadjuvant/adjuvant therapy with platinum-based chemotherapy, a&#xD;
             treatment-free interval of at least 6 months is required.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Palliative radiation treatment for ESCC within 4 weeks of study treatment initiation&#xD;
&#xD;
          2. Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC&#xD;
&#xD;
          3. Received prior therapies targeting programmed cell death protein-1 (PD-1), programmed&#xD;
             cell death protein ligand-1 (PD-L1) or PD-L2&#xD;
&#xD;
          4. Participants with evidence of fistula (either esophageal/bronchial or&#xD;
             esophageal/aorta)&#xD;
&#xD;
          5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent&#xD;
             drainage or medical intervention (clinically significant recurrence requiring an&#xD;
             additional intervention within 2 weeks of intervention)&#xD;
&#xD;
          6. Evidence of complete esophageal obstruction not amenable to treatment&#xD;
&#xD;
          7. Unintentional weight loss ≥ 5% within one month prior to randomization or Nutritional&#xD;
             Risk Index (NRI) &lt; 83.5 per investigator's choice&#xD;
&#xD;
          8. Locally advanced esophageal carcinoma that is resectable or potentially curable with&#xD;
             radiation therapy per local investigator.&#xD;
&#xD;
          9. Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV)&#xD;
             carriers whose HBV DNA is ≥ 500 IU/mL or participants with active hepatitis C virus&#xD;
             (HCV)&#xD;
&#xD;
        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liyun Li, MD</last_name>
    <role>Study Director</role>
    <affiliation>BeiGene</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Smilow Cancer Hospital at Yale-New Haven - Neurology</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510-3220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital (AGH)</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212-4756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina Hollings Cancer Center</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center of San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renovatio Clinical</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77389</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coffs Harbour Hospital</name>
      <address>
        <city>Coffs Harbour</city>
        <state>Pacific Highway</state>
        <zip>2450</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Townsville Hospital</name>
      <address>
        <city>Douglas</city>
        <state>Queensland</state>
        <zip>4814</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ashford Cancer Centre Research</name>
      <address>
        <city>Kurralta Park</city>
        <state>South Australia</state>
        <zip>6008</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Hobart Hospital</name>
      <address>
        <city>Hobart</city>
        <state>Tasmania</state>
        <zip>7000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital</name>
      <address>
        <city>Fitzroy</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ballarat Oncology &amp; Haematology Services</name>
      <address>
        <city>Wendouree</city>
        <state>Victoria</state>
        <zip>3355</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antwerp University Hospital</name>
      <address>
        <city>Edegem</city>
        <state>Antwerpen</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet - Oncologie Médicale</name>
      <address>
        <city>Anderlecht</city>
        <state>Brussels Capital Region</state>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grand Hôpital de Charleroi - Site Notre-Dame</name>
      <address>
        <city>Charleroi</city>
        <state>Hainaut</state>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent - Radiologie</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven - Campus Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology</name>
      <address>
        <city>Brugge</city>
        <state>West-Vlaanderen</state>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHC Mont Legia</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Liège Sart Tilman</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anhui Provincial Cancer Hospital</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230088</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anhui Medical University - The Second Hospital</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230601</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230601</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hospital - Oncology</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Fifth Medical Center of Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100071</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital - Oncology</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujian Provincial Cancer Hospital - Oncology</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Fujian Medical University</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>35005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital Xiamen University</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>361004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Province Traditional Chinese Medical Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Sixth Affiliated Hospital of Sun Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510655</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Hospital of Shantou University Medical College</name>
      <address>
        <city>Shantou</city>
        <state>Guangdong</state>
        <zip>515031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Hospital of Guangxi Medical University</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hainan General Hospital - Oncology</name>
      <address>
        <city>Haikou</city>
        <state>Hainan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Tumor Hospital of Harbin Medical University</name>
      <address>
        <city>Haerbin</city>
        <state>Heilongjiang</state>
        <zip>150081</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University - Oncology</name>
      <address>
        <city>Henan</city>
        <state>Henan</state>
        <zip>450052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xinxiang Medical University</name>
      <address>
        <city>Xinxiang</city>
        <state>Henan</state>
        <zip>453100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital - Oncology</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hubei Cancer Hospital - Oncology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430079</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xiangyang Central Hospital</name>
      <address>
        <city>Xiangyang</city>
        <state>Hubei</state>
        <zip>441021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital - GCP Office</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Changzhou - Oncology</name>
      <address>
        <city>Changzhou</city>
        <state>Jiangsu</state>
        <zip>213003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nantong Cancer Hospital</name>
      <address>
        <city>Nantong</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Jiangnan University</name>
      <address>
        <city>Wuxi</city>
        <state>Jiangsu</state>
        <zip>214062</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Xuzhou Medical University - Radiology</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Jiangsu People's Hospital</name>
      <address>
        <city>Yangzhou</city>
        <state>Jiangsu</state>
        <zip>225001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liaoning Cancer Hospital &amp; Institute - Medical Oncology - Oncology</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110017</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quanzhou First Hospital - Radiotherapy/Nuclear Medicine</name>
      <address>
        <city>Quanzhou</city>
        <state>Quanzhou</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shandong Cancer Hospital and Institute, Shandong First Medical University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250117</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Linyi Cancer Hospital</name>
      <address>
        <city>Linyi</city>
        <state>Shandong</state>
        <zip>276001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WeiFang People's Hospital</name>
      <address>
        <city>Weifang</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanxi Provincial People's Hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute and Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anhui Provincial Hospital - Oncology</name>
      <address>
        <city>Hefei</city>
        <zip>230001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xiamen University - Oncology</name>
      <address>
        <city>Xiamen</city>
        <zip>361005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultní Nemocnice Olomouc</name>
      <address>
        <city>Olomouc</city>
        <zip>779 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomayerova nemocnice</name>
      <address>
        <city>Praha 4</city>
        <zip>140 59</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Na Bulovce</name>
      <address>
        <city>Praha 8</city>
        <zip>180 81</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie</name>
      <address>
        <city>Brest Cedex</city>
        <state>Bretagne</state>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Besançon- Hôpital Jean Minjoz</name>
      <address>
        <city>Besançon Cedex</city>
        <state>Doubs</state>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux Hôpital Du Haut-Lévêque</name>
      <address>
        <city>Pessac Cedex</city>
        <state>Gironde</state>
        <zip>33608</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Hospitalier Franco-Britannique (IHFB) - Levallois-Perret - 4 Rue Kleber</name>
      <address>
        <city>Levallois-Perret</city>
        <state>Hauts-de-Seine</state>
        <zip>92300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICO</name>
      <address>
        <city>Saint-Herblain</city>
        <state>Loire-Atlantique</state>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center Oscar Lambret - Alliance Member</name>
      <address>
        <city>Lille</city>
        <state>Nord</state>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint-Antoine / Service d'Hepato-Gastro-Enterologie</name>
      <address>
        <city>Paris Cedex 12</city>
        <state>Paris</state>
        <zip>75571</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Léon Bérard</name>
      <address>
        <city>Lyon</city>
        <state>Rhône</state>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <state>Vienne</state>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Europeen Georges Pompidou - Digestive Oncology</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint Joseph - Oncologie</name>
      <address>
        <city>Paris</city>
        <zip>75074</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SLK Kliniken Heilbronn GmbH - Klinik für Radiologie, Minimalinvasive Therapien und Nuklearmedizin</name>
      <address>
        <city>Heilbronn</city>
        <state>Baden-Württemberg</state>
        <zip>74078</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Tuebingen</name>
      <address>
        <city>Tuebingen</city>
        <state>Baden-Württemberg</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johannes Wesling Klinikum Minden</name>
      <address>
        <city>Minden</city>
        <state>Nordrhein-Westfalen</state>
        <zip>32429</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Mainz</name>
      <address>
        <city>Mainz</city>
        <state>Rheinland-Pfalz</state>
        <zip>55101</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Of Leipzig</name>
      <address>
        <city>Leipzig</city>
        <state>Sachsen</state>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Hamburg- Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20251</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc - Oncologia Medica</name>
      <address>
        <city>Torino</city>
        <state>Ancona</state>
        <zip>60126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori', IRCCS - Laboratorio</name>
      <address>
        <city>Meldola</city>
        <state>Emilia-Romagna</state>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc - Oncologia Medica</name>
      <address>
        <city>Ancona</city>
        <zip>60126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ieo, Irccs</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asst Grande Ospedale Metropolitano Niguarda</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Oncologico Veneto IOV-IRCCS</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SO S.Chiara, AOU Pisana - Oncologia 2</name>
      <address>
        <city>Pisa</city>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East - Gastrointestinal Oncology</name>
      <address>
        <city>Kashiwa</city>
        <state>Chiba</state>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu Medical Center - Gastroenterological Surgery</name>
      <address>
        <city>Fukuoka</city>
        <state>Hukuoka</state>
        <zip>810-8563</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyushu Cancer Center - GI and Medical Oncology</name>
      <address>
        <city>Fukuoka</city>
        <state>Hukuoka</state>
        <zip>811-1395</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe City Medical Center General Hospital - Medical Oncology</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kagawa University Hospital - Oncology</name>
      <address>
        <city>Kita-gun</city>
        <state>Kagawa</state>
        <zip>761-0793</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cancer Center - Gastroenterological surgery</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>241-8515</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital, Kyoto Prefectural Univ of Medicine - Gastroenterology</name>
      <address>
        <city>Kamigyō-ku</city>
        <state>Kyoto</state>
        <zip>602-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindai University Nara Hospital</name>
      <address>
        <city>Ikoma</city>
        <state>Osaka</state>
        <zip>630-0293</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital - Medical Oncology</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital - Gastrointestinal Oncology</name>
      <address>
        <city>Chuo Ku</city>
        <state>Tokyo</state>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo Cancer Center</name>
      <address>
        <city>Akashi</city>
        <zip>673-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akita University Hospital - Pediatrics</name>
      <address>
        <city>Akita-shi</city>
        <zip>010-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansai Rosai Hospital - Gastroenterological Surgery</name>
      <address>
        <city>Amagasaki</city>
        <zip>660-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima University Hospital - Gastrointestinal Surgery</name>
      <address>
        <city>Hiroshima</city>
        <zip>734-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kumamoto University Hospital</name>
      <address>
        <city>Kumamoto</city>
        <zip>860-8556</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital</name>
      <address>
        <city>Kyoto</city>
        <zip>606-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niigata Cancer Center Hospital</name>
      <address>
        <city>Niigata</city>
        <zip>951-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka International Cancer Institute - Clinical Oncology</name>
      <address>
        <city>Osaka</city>
        <zip>541-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Cancer Center - Gastroenterology</name>
      <address>
        <city>Saitama</city>
        <zip>362-0806</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital - Hematology/Oncology</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggido [Kyonggi-do]</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHA Bundang Medical Center, CHA University - Oncology</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggido</state>
        <zip>13496</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center - Oncology</name>
      <address>
        <city>Incheon</city>
        <state>Incheon Gwang'yeogsi [Inch'n-K</state>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hwasun Hospital - Hematology and Oncology Clinic</name>
      <address>
        <city>Hwasun</city>
        <state>Jeonranamdo [Chollanam-do]</state>
        <zip>58128</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi [Seoul-T'ukp]</state>
        <zip>6591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center - Hematology-Oncology</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi [Seoul-T'ukp</state>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SMG-SNU Boramae Medical Center - Oncology</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi [Seoul-T'ukp</state>
        <zip>07061</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital - Hematology-Oncology</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi [Seoul-T'ukp</state>
        <zip>08308</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keimyung University Dongsan Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>42601</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center - Oncology</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>02-034</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi</name>
      <address>
        <city>Brzozow</city>
        <state>Podkarpackie</state>
        <zip>36-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Wojewodzki w Koszalinie</name>
      <address>
        <city>Koszalin</city>
        <state>Pomorskie</state>
        <zip>75-581</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii</name>
      <address>
        <city>Olsztyn</city>
        <state>Warminsko-mazurskie</state>
        <zip>10-228</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center Sp. z o.o., Medic-R Sp. K.</name>
      <address>
        <city>Poznan</city>
        <state>Wielkopolskie</state>
        <zip>60-848</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutul Oncologic &quot;Prof.Dr.I.Chiricuta&quot; Cluj Napoca</name>
      <address>
        <city>Cluj-Napoca</city>
        <state>Cluj</state>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiotherapy Center Cluj</name>
      <address>
        <city>Floreşti</city>
        <state>Cluj</state>
        <zip>407280</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrul de Oncologie Sf. Nectarie</name>
      <address>
        <city>Craiova</city>
        <state>Dolj</state>
        <zip>200347</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutul Clinic Fundeni</name>
      <address>
        <city>Bucuresti</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Coltea</name>
      <address>
        <city>Bucuresti</city>
        <zip>030171</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisprof</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400641</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrul de Oncologie Euroclinic</name>
      <address>
        <city>Iaşi</city>
        <zip>700106</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkhangelsk Regional Clinical Oncological Dispensary</name>
      <address>
        <city>Arkhangelsk</city>
        <state>Arkhangel'skaya Oblast'</state>
        <zip>163045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leningrad Regional Oncology Dispensary</name>
      <address>
        <city>Kuz'molovskiy</city>
        <state>Leningradskaya Oblast</state>
        <zip>188663</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orenburg Regional Clinical Oncology Center</name>
      <address>
        <city>Orenburg</city>
        <state>Orenburgskaya Oblast</state>
        <zip>460021</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rostov Research Institute of Oncology (RRIO)</name>
      <address>
        <city>Rostov-Na-Donu</city>
        <state>Rostovskaya Oblast</state>
        <zip>344037</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Saint-Petersburg State Medical University named after Academician I.P. Pavlov</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Sankt-Peterburg</state>
        <zip>194291</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Oncology Dispensary</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Sankt-Peterburg</state>
        <zip>198255</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ivanovo Regional Oncology Dispensary</name>
      <address>
        <city>Ivanovo</city>
        <zip>153015</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Petrov Research Institute of Oncology</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Central de Asturias</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Catalá d´Oncología (I.C.O.)</name>
      <address>
        <city>L'Hospitalet De Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Madrid Norte Sanchinarro</name>
      <address>
        <city>Sanchinarro</city>
        <state>Madrid</state>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'Hebrón</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H.U.V.Arrixaca</name>
      <address>
        <city>Murcia</city>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen De La Victoria</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Veterans General Hospital - Thoracic Surgery</name>
      <address>
        <city>Kaohsiung</city>
        <zip>813</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital - Oncology - Taichung</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chi Mei Medical Center - YongKang - Chi Mei Medical Center</name>
      <address>
        <city>Tainan</city>
        <zip>71004</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chi Mei Hospital, Liouying - Department of Oncology</name>
      <address>
        <city>Tainan</city>
        <zip>73657</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guys and St Thomas' Hospital</name>
      <address>
        <city>London</city>
        <state>City Of London</state>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden NHS Foundation Trust - Royal Marsden Hospi</name>
      <address>
        <city>London</city>
        <state>City Of London</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Vernon Cancer Centre</name>
      <address>
        <city>Northwood</city>
        <state>England</state>
        <zip>HA6 2RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maidstone and Tunbridge Wells NHS Trust - Kent Oncology Centre</name>
      <address>
        <city>Maidstone</city>
        <state>Kent</state>
        <zip>ME16 9QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beatson West of Scotland Cancer Centre - Oncology</name>
      <address>
        <city>Glasgow</city>
        <state>Scotland</state>
        <zip>G12 0YN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation Trust - Oak Road Treatment Centr</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>China</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>April 14, 2023</last_update_submitted>
  <last_update_submitted_qc>April 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Esophageal Squamous Cell Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Tislelizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03783442
org study id: BGB-A317-306
secondary id: 2018-000587-28
secondary id: CTR20181013
secondary id: JapicCTI-194741
nct id: NCT03783442
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of Tislelizumab as first
      line treatment in combination with chemotherapy in participants with advanced
      unresectable/metastatic esophageal squamous cell carcinoma (ESCC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Overall Survival (OS)
time frame: Up to approximately 40 months from date of the first participant randomization
description: OS is defined as the time from the date of randomization until the date of death due to any cause
measure: Progression-Free Survival (PFS)
time frame: Approximately 40 months from date of the first participant randomization
description: PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first
measure: Objective Response Rate (ORR)
time frame: Approximately 40 months from date of the first participant randomization
description: ORR is defined as the proportion of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by the investigator per RECIST v1.1
measure: Overall survival (OS) in the PD-L1 score ≥ 10% subgroup
time frame: Approximately 40 months from date of the first participant randomization
description: OS is defined as the time from the date of randomization until the date of death due to any cause
measure: Duration of Response (DOR)
time frame: Approximately 40 months from date of the first participant randomization
description: DOR is defined as the time from the first determination of an objective response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever comes first
measure: Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30)
time frame: Approximately 40 months from date of the first participant randomization
measure: Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer specific module (EORTC QLQ-OES18)
time frame: Approximately 40 months from date of the first participant randomization
measure: Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using the generic health state instrument European Quality of Life-5 Dimensions (EuroQol 5D EQ-5D-5L)
time frame: Approximately 40 months from date of the first participant randomization
measure: Number of participants experiencing Adverse Events (AEs)
time frame: Approximately 40 months from date of the first participant randomization
arm group label: Tislelizumab + chemotherapy
arm group type: Experimental
description: Tislelizumab administered with chemotherapy doublet:
Doublet A: Cisplatin or Oxaliplatin plus Fluorouracil (5-FU); Doublet B: Cisplatin or Oxaliplatin plus Capecitabine; Doublet C: Cisplatin or Oxaliplatin plus Paclitaxel
arm group label: Placebo + chemotherapy
arm group type: Active Comparator
description: Placebo administered with chemotherapy doublet:
Doublet A: Cisplatin or Oxaliplatin plus Fluorouracil (5-FU); Doublet B: Cisplatin or Oxaliplatin plus Capecitabine; Doublet C: Cisplatin or Oxaliplatin plus Paclitaxel
intervention type: Drug
intervention name: Cisplatin
description: 60 to 80 mg/m^2 intravenously (IV) on Day 1 once every 3 weeks (Q3W)
arm group label: Placebo + chemotherapy
arm group label: Tislelizumab + chemotherapy
intervention type: Drug
intervention name: Oxaliplatin
description: 130 mg/m^2 IV on Day 1 Q3W
arm group label: Placebo + chemotherapy
arm group label: Tislelizumab + chemotherapy
intervention type: Drug
intervention name: Fluorouracil (5-FU)
description: 750 to 800 mg/m^2 IV continuous infusion over 24 hours daily on Days 1 to 5 Q3W
arm group label: Placebo + chemotherapy
arm group label: Tislelizumab + chemotherapy
intervention type: Drug
intervention name: Capecitabine
description: 1000 mg/m^2 orally (PO) twice daily (BID) on Days 1 to 14 Q3W
arm group label: Placebo + chemotherapy
arm group label: Tislelizumab + chemotherapy
intervention type: Drug
intervention name: Paclitaxel
description: 175 mg/m^2 IV on Day 1 Q3W
arm group label: Placebo + chemotherapy
arm group label: Tislelizumab + chemotherapy
intervention type: Drug
intervention name: Tislelizumab
description: 200 mg IV Q3W
arm group label: Tislelizumab + chemotherapy
intervention type: Drug
intervention name: Placebo
description: Placebo to match Tislelizumab
arm group label: Placebo + chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Liyun Li, MD
role: Study Director
affiliation: BeiGene
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country: Australia
country: Belgium
country: China
country: Czechia
country: France
country: Germany
country: Italy
country: Japan
country: Korea, Republic of
country: Poland
country: Romania
country: Russian Federation
country: Spain
country: Taiwan
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Esophageal Squamous Cell Carcinoma
mesh term: Paclitaxel
mesh term: Fluorouracil
mesh term: Capecitabine
mesh term: Oxaliplatin
mesh term: Tislelizumab
sharing ipd: Yes