<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/NCT03777657</url>
  </required_header>
  <id_info>
    <org_study_id>BGB-A317-305</org_study_id>
    <secondary_id>2018-000312-24</secondary_id>
    <secondary_id>CTR20181841</secondary_id>
    <secondary_id>JapicCTI-194799</secondary_id>
    <nct_id>NCT03777657</nct_id>
  </id_info>
  <brief_title>Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) Plus Platinum and Fluoropyrimidine Versus Placebo Plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BeiGene</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BeiGene</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to&#xD;
      compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line&#xD;
      (1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal&#xD;
      junction (GEJ) adenocarcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Actual">February 28, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 48 months</time_frame>
    <description>The time from the date of randomization to the date of death due to any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>Up to 30 months</time_frame>
    <description>The time from the date of randomization to the date of the first objectively documented tumor progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR)</measure>
    <time_frame>Up to 48 months</time_frame>
    <description>The proportion of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months</time_frame>
    <description>The time from the first determination of an objective response per Response Evaluation Criteria in Solid Tumors v1.1, until the first documentation of progression or death, whichever occurs first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22)</measure>
    <time_frame>Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Score (EORTC QLQ-30)</measure>
    <time_frame>Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in European Quality of Life 5-Dimensions 5-Levels Health Questionnaire Score (EQ-5D-5L)</measure>
    <time_frame>Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants experiencing Adverse Events (AEs)</measure>
    <time_frame>Up to 48 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants experiencing Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 48 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>Up to 48 Months</time_frame>
    <description>Proportion of complete response + partial response + stable disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical benefit rate (CBR)</measure>
    <time_frame>Up to 48 Months</time_frame>
    <description>Proportion of complete response + partial response + durable stable disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to response (TTR)</measure>
    <time_frame>Up to 48 Months</time_frame>
    <description>Time from randomization to the first determination of an objective response</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">997</enrollment>
  <condition>Gastric, or Gastroesophageal Junction Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Tislelizumab (BGB-A317) + chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tislelizumab and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-Fluorouracil regimens are used as the backbone chemotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + chemotherapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-FU regimens are used as the backbone chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tislelizumab</intervention_name>
    <description>200 mg IV on Day 1 during each 21-day cycle</description>
    <arm_group_label>Tislelizumab (BGB-A317) + chemotherapy</arm_group_label>
    <other_name>BGB-A317</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo to match tislelizumab on Day 1 during each 21-day cycle</description>
    <arm_group_label>Placebo + chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>80 mg/m² IV on Day 1 during each 21-day cycle</description>
    <arm_group_label>Placebo + chemotherapy</arm_group_label>
    <arm_group_label>Tislelizumab (BGB-A317) + chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>130 mg/m² IV on Day 1 during each 21-day cycle</description>
    <arm_group_label>Placebo + chemotherapy</arm_group_label>
    <arm_group_label>Tislelizumab (BGB-A317) + chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>1000 mg/m² orally twice daily (BD) Days 1 through 14 (14 days total) during each 21-day cycle</description>
    <arm_group_label>Placebo + chemotherapy</arm_group_label>
    <arm_group_label>Tislelizumab (BGB-A317) + chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-FU</intervention_name>
    <description>800 mg/m²/day IV using continuous pumping system on Days 1 through 5 during each 21-day cycle</description>
    <arm_group_label>Placebo + chemotherapy</arm_group_label>
    <arm_group_label>Tislelizumab (BGB-A317) + chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Locally advanced unresectable or metastatic GC or GEJ carcinoma and have&#xD;
             histologically confirmed adenocarcinoma&#xD;
&#xD;
          2. No previous systemic therapy for locally advanced unresectable or metastatic&#xD;
             gastric/GEJ cancer. NOTE: Participants may have received prior neoadjuvant or adjuvant&#xD;
             therapy as long as it was completed and have no recurrence or disease progression for&#xD;
             at least 6 months.&#xD;
&#xD;
          3. ECOG PS ≤ 1 within 7 days prior to randomization&#xD;
&#xD;
          4. Adequate organ function as indicated by the following laboratory values ≤ days prior&#xD;
             to randomization&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Has squamous cell or undifferentiated or other histological type GC&#xD;
&#xD;
          2. Active leptomeningeal disease or uncontrolled brain metastasis&#xD;
&#xD;
          3. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2&#xD;
&#xD;
          4. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug&#xD;
             specifically targeting T-cell co-stimulation or checkpoint pathways&#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>Jin Wang, MD</last_name>
    <role>Study Director</role>
    <affiliation>BeiGene</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California Davis Health System</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Regional Medical Center</name>
      <address>
        <city>Newnan</city>
        <state>Georgia</state>
        <zip>30265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital - Central</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reading Hospital</name>
      <address>
        <city>West Reading</city>
        <state>Pennsylvania</state>
        <zip>19611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC - Nashville</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Bengbu Medical College</name>
      <address>
        <city>Bengbu</city>
        <state>Anhui</state>
        <zip>233004</zip>
        <country>China</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>The Second Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>231200</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Chao Yang Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Hospital Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>No. 3 Hospital, Beijing University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100083</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>Chinese PLA General Hospital Medical School of Chinese PLA</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Luhe Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>101100</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>350005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujian Cancer Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Lanzhou University</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <zip>73000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Foshan</name>
      <address>
        <city>Foshan</city>
        <state>Guangdong</state>
        <zip>528000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yat-sen University, Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong General Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenzhen People's Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guilin Medical University</name>
      <address>
        <city>Guilin</city>
        <state>Guangxi</state>
        <zip>41000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hainan General Hospital</name>
      <address>
        <city>Haikou</city>
        <state>Hainan</state>
        <zip>570311</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fourth Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>50051</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150081</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Provincial People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Hospital of Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430023</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hubei Cancer Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430079</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Drum Tower Hospital of Nanjing University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Cancer Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</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 Tumor Hospital</name>
      <address>
        <city>Nantong</city>
        <state>Jiangsu</state>
        <zip>226361</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>The First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Shenyang Military Region</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liaoning Cancer Hospital &amp; Institute</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110042</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shandong Cancer Hospital</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>The Affiliated Hospital of Qingdao University</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266071</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai General Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daping Hospital of The 3rd Military University</name>
      <address>
        <city>Chongqing</city>
        <state>Sichuan</state>
        <zip>400042</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University General Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute &amp; Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yunnan Cancer Hospital</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650118</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine</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>Centre Antoine Lacassagne</name>
      <address>
        <city>Nice cedex 02</city>
        <state>Alpes Maritimes</state>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Georges François Leclerc</name>
      <address>
        <city>Dijon cedex</city>
        <state>Côte-d'Or</state>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux - Hôpital Haut-Lévêque</name>
      <address>
        <city>Pessac</city>
        <state>Gironde</state>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Besançon - Hôpital Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Timone</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Nord Franche Comté</name>
      <address>
        <city>Montbéliard</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona</name>
      <address>
        <city>Torrette</city>
        <state>Ancona</state>
        <zip>60020</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale Casa Sollievo della Sofferenza</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <state>Foggia</state>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Tumori Fondazione G. Pascale</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IOV - Istituto Oncologico Veneto IRCCS</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Pisana</name>
      <address>
        <city>Pisa</city>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Policlinico Tor Vergata</name>
      <address>
        <city>Roma</city>
        <zip>133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Città della Salute e della Scienza di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiba Cancer Center</name>
      <address>
        <city>Chiba-shi</city>
        <state>Chiba-Ken</state>
        <zip>260-8717</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tesshokai Kameda General Hospital</name>
      <address>
        <city>Kamogawa-shi</city>
        <state>Chiba-ken</state>
        <zip>296-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukui Prefectural Hospital</name>
      <address>
        <city>Fukui-shi</city>
        <state>Fukui-ken</state>
        <zip>910-8526</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHO Kyushu Cancer Center</name>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka-Ken</state>
        <zip>811-1395</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gunma Prefectural Cancer Center</name>
      <address>
        <city>Ota-shi</city>
        <state>Gunma -ken</state>
        <zip>373-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHO Takasaki General Medical Center</name>
      <address>
        <city>Takasaki-shi</city>
        <state>Gunma-ken</state>
        <zip>370-0829</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima City Hiroshima Citizens Hospita</name>
      <address>
        <city>Hiroshima-shi</city>
        <state>Hiroshima-ken,</state>
        <zip>730-8518</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>060-8648</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JOHAS Kansai Rosai Hospital</name>
      <address>
        <city>Amagasaki-shi</city>
        <state>Hyogo-ken</state>
        <zip>660-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ishikawa Prefectural Central Hospital</name>
      <address>
        <city>Kanazawa-shi</city>
        <state>Ishikawa-ken</state>
        <zip>920-8530</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kagawa University Hospital</name>
      <address>
        <city>Kita-gun</city>
        <state>Kagawa-Ken</state>
        <zip>761-0793</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cancer Center</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>241-8515</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oita University Hospital</name>
      <address>
        <city>Yufu-shi</city>
        <state>Oita-Ken</state>
        <zip>879-5593</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurashiki Central Hospital</name>
      <address>
        <city>Kurashiki-shi</city>
        <state>Okayama-ken</state>
        <zip>710-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama-shi</city>
        <state>Okayama-ken</state>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Izumi City General Hospital</name>
      <address>
        <city>Izumi-shi</city>
        <state>Osaka-Fu</state>
        <zip>594-0073</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHO Osaka National Hospital</name>
      <address>
        <city>Osaka-shi</city>
        <state>Osaka-fu</state>
        <zip>540-0006</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka International Cancer Institute - Clinical Oncology</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <zip>537-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical University International Medical Center</name>
      <address>
        <city>Hidaka-shi,</city>
        <state>Saitama-ken</state>
        <zip>350-1298</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Cancer Center</name>
      <address>
        <city>Ina</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamamatsu University School of Medicine, University Hospital</name>
      <address>
        <city>Hamamatsu-shi</city>
        <state>Shizuoka-Ken</state>
        <zip>431-3192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Medical and Pharmaceutical University Hospital</name>
      <address>
        <city>Osaka-fu</city>
        <state>Takatsuki-shi</state>
        <zip>569-8686</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo-To</state>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Metropolitan Tama Medical Center</name>
      <address>
        <city>Fuchu-shi</city>
        <state>Tokyo-to</state>
        <zip>183-8524</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Institute Hospital of JFCR</name>
      <address>
        <city>Koto-ku</city>
        <state>Tokyo-To</state>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center Hospital of the National Center for Global Health and Medicine</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo-To</state>
        <zip>162-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurashiki Central Hospital</name>
      <address>
        <city>Kurashiki</city>
        <zip>710-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaki Citizen Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>989-6183</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang-si</city>
        <state>Gyeonggi-do</state>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University</name>
      <address>
        <city>Seoul</city>
        <state>Gyeonggi-do</state>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, St. Vincent's Hospital</name>
      <address>
        <city>Suwon-si</city>
        <state>Gyeonggi-do</state>
        <zip>16247</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggi-do</state>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Chilgok Hospital</name>
      <address>
        <city>Daegu</city>
        <state>Gyeongsangbuk-do</state>
        <zip>41404</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hwasun Hospital</name>
      <address>
        <city>Hwasun</city>
        <state>Jeollanam-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chung-Ang University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06973</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>3080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>5505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne</name>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna</name>
      <address>
        <city>Lodz</city>
        <zip>90-242</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Przychodnia Med-Polonia Sp. z o.o.</name>
      <address>
        <city>Poznan</city>
        <zip>60-693</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii-Instytut im. M. Sklodowskiej Curie</name>
      <address>
        <city>Warszawa</city>
        <zip>02-034</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pan American Oncology Trials, LLC</name>
      <address>
        <city>San Juan</city>
        <zip>902</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RBIH &quot;Ivanovo Regional Oncological Dispensary&quot;</name>
      <address>
        <city>Ivanovo</city>
        <zip>153040</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;VitaMed&quot; LLC</name>
      <address>
        <city>Moscow</city>
        <zip>129515</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBIH of Arkhangelsk region &quot;Arkhangelsk Clinical Oncological Dispensary&quot;</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBHI of Novosibirsk</name>
      <address>
        <city>Novosibirsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BHI of Omsk region &quot;Clinical Oncology Dispensary&quot;</name>
      <address>
        <city>Omsk</city>
        <zip>644013</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI &quot;Clinical Research and Practical Center for specialized medical care (oncology)&quot;</name>
      <address>
        <city>Pesochnyy</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pavlov First Saint Petersburg State Medical University</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Educational Institution of Higher Education &quot;Medical University &quot;REAVIZ&quot;</name>
      <address>
        <city>Samara</city>
        <zip>443011</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBIH &quot; Volgograd Regional Clinical Oncological Dispensary # 1&quot;</name>
      <address>
        <city>Volgograd</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBIH of Yaroslavl region &quot;Regional Clinical Oncological Hospital&quot;</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150054</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>8036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Basurto</name>
      <address>
        <city>Bilbao</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Elche</name>
      <address>
        <city>Elche</city>
        <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>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario HM Madrid Sanchinarro</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro Majadahonda</name>
      <address>
        <city>Majadahonda</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Regional Universitario de Malaga</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Navarra</name>
      <address>
        <city>Pamplona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia</name>
      <address>
        <city>Valence</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Initia Oncologia, SLP</name>
      <address>
        <city>Valencia</city>
        <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 Medical University Chung-Ho Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>807</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acibadem Adana Hospital</name>
      <address>
        <city>Adana</city>
        <zip>1130</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>6105</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akdeniz University Medical Faculty</name>
      <address>
        <city>Antalya</city>
        <zip>7058</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inonu Uni. Med. Fac.</name>
      <address>
        <city>Malatya</city>
        <zip>44280</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Velindre Cancer Centre</name>
      <address>
        <city>Cardiff</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute UK</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>France</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Romania</country>
  </removed_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>September 13, 2023</last_update_submitted>
  <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 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>Adenocarcinoma</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03777657
org study id: BGB-A317-305
secondary id: 2018-000312-24
secondary id: CTR20181841
secondary id: JapicCTI-194799
nct id: NCT03777657
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to
      compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line
      (1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal
      junction (GEJ) adenocarcinoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Overall Survival (OS)
time frame: Up to 48 months
description: The time from the date of randomization to the date of death due to any cause
measure: Progression-free survival (PFS)
time frame: Up to 30 months
description: The time from the date of randomization to the date of the first objectively documented tumor progression
measure: Overall response rate (ORR)
time frame: Up to 48 months
description: The proportion of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1
measure: Duration of response (DOR)
time frame: Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months
description: The time from the first determination of an objective response per Response Evaluation Criteria in Solid Tumors v1.1, until the first documentation of progression or death, whichever occurs first
measure: Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22)
time frame: Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months
measure: Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Score (EORTC QLQ-30)
time frame: Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months
measure: Change from baseline in European Quality of Life 5-Dimensions 5-Levels Health Questionnaire Score (EQ-5D-5L)
time frame: Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months
measure: Number of participants experiencing Adverse Events (AEs)
time frame: Up to 48 months
measure: Number of participants experiencing Serious Adverse Events (SAEs)
time frame: Up to 48 months
measure: Disease control rate (DCR)
time frame: Up to 48 Months
description: Proportion of complete response + partial response + stable disease
measure: clinical benefit rate (CBR)
time frame: Up to 48 Months
description: Proportion of complete response + partial response + durable stable disease
measure: time to response (TTR)
time frame: Up to 48 Months
description: Time from randomization to the first determination of an objective response
arm group label: Tislelizumab (BGB-A317) + chemotherapy
arm group type: Experimental
description: Tislelizumab and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-Fluorouracil regimens are used as the backbone chemotherapy.
arm group label: Placebo + chemotherapy
arm group type: Placebo Comparator
description: Placebo and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-FU regimens are used as the backbone chemotherapy.
intervention type: Drug
intervention name: Tislelizumab
description: 200 mg IV on Day 1 during each 21-day cycle
arm group label: Tislelizumab (BGB-A317) + chemotherapy
other name: BGB-A317
intervention type: Drug
intervention name: Placebo
description: Placebo to match tislelizumab on Day 1 during each 21-day cycle
arm group label: Placebo + chemotherapy
intervention type: Drug
intervention name: Cisplatin
description: 80 mg/m² IV on Day 1 during each 21-day cycle
arm group label: Placebo + chemotherapy
arm group label: Tislelizumab (BGB-A317) + chemotherapy
intervention type: Drug
intervention name: Oxaliplatin
description: 130 mg/m² IV on Day 1 during each 21-day cycle
arm group label: Placebo + chemotherapy
arm group label: Tislelizumab (BGB-A317) + chemotherapy
intervention type: Drug
intervention name: Capecitabine
description: 1000 mg/m² orally twice daily (BD) Days 1 through 14 (14 days total) during each 21-day cycle
arm group label: Placebo + chemotherapy
arm group label: Tislelizumab (BGB-A317) + chemotherapy
intervention type: Drug
intervention name: 5-FU
description: 800 mg/m²/day IV using continuous pumping system on Days 1 through 5 during each 21-day cycle
arm group label: Placebo + chemotherapy
arm group label: Tislelizumab (BGB-A317) + chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jin Wang, MD
role: Study Director
affiliation: BeiGene
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country: China
country: France
country: Italy
country: Japan
country: Korea, Republic of
country: Poland
country: Puerto Rico
country: Russian Federation
country: Spain
country: Taiwan
country: Turkey
country: United Kingdom
country: United States
country: Romania
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Esophageal Neoplasms
mesh term: Capecitabine
mesh term: Oxaliplatin
mesh term: Tislelizumab
sharing ipd: Yes