<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/NCT04486651</url>
  </required_header>
  <id_info>
    <org_study_id>HX008-III-GC-01</org_study_id>
    <nct_id>NCT04486651</nct_id>
  </id_info>
  <brief_title>HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer</brief_title>
  <official_title>A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HX008 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taizhou Hanzhong biomedical co. LTD</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taizhou Hanzhong biomedical co. LTD</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double-blinded, multicenter study to evaluate the efficacy and safety&#xD;
      of HX008 injection combined with irinotecan versus placebo combined with irinotecan as&#xD;
      second-line therapy in patients with adcanced gastric or gastroesophageal junction (GEJ)&#xD;
      adenocarcinoma who have had tumor progression after first-line treatment with platinum and/or&#xD;
      fluropyrimidine therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 16, 2020</start_date>
  <completion_date type="Anticipated">August 10, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 10, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS) in All Participants</measure>
    <time_frame>Up to approximately 36 months</time_frame>
    <description>OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival (OS) in Participants With PD-L1 CPS≥1</measure>
    <time_frame>Up to approximately 36 months</time_frame>
    <description>OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm with PD-L1 CPS≥1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)</measure>
    <time_frame>Up to approximately 36 months</time_frame>
    <description>PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by investigators or death due to any cause, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)</measure>
    <time_frame>Up to approximately 36 months</time_frame>
    <description>ORR was defined as the percentage of participants who have a complete response (CR) or a partial response (PR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)</measure>
    <time_frame>Up to approximately 36 months</time_frame>
    <description>DCR was defined as the percentage of participants who have a CR or a PR or a stable disease (SD), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)</measure>
    <time_frame>Up to approximately 36 months</time_frame>
    <description>DOR was defined as the time from the first documented evidence of a response of CR or PR, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">560</enrollment>
  <condition>Stomach Cancer</condition>
  <arm_group>
    <arm_group_label>HX008 plus Irinotecan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants recieve HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo plus Irinotecan</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants recieve placebo intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Irinotecan Hydrochloride Injection</intervention_name>
    <description>160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle.</description>
    <arm_group_label>HX008 plus Irinotecan</arm_group_label>
    <arm_group_label>Placebo plus Irinotecan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HX008</intervention_name>
    <description>200 mg administered as IV infusion on Day 1 of each 21-day cycle.</description>
    <arm_group_label>HX008 plus Irinotecan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered as IV infusion on Day 1 of each 21-day cycle.</description>
    <arm_group_label>Placebo plus Irinotecan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Understood and signed an informed consent form.&#xD;
&#xD;
          -  Age ≥ 18 and ≤ 75 years old, male or female.&#xD;
&#xD;
          -  Has histologically- or cytologically-confirmed diagnosis of locally advanced&#xD;
             unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction&#xD;
             (GEJ).&#xD;
&#xD;
          -  Has experienced documented objective radiographic or clinical disease progression&#xD;
             during or after first-line therapy containing platinum and/or fluoropyrimidine&#xD;
             therapy.&#xD;
&#xD;
          -  Willing to provide tissue for PD-L1 biomarker analysis.&#xD;
&#xD;
          -  Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)&#xD;
             Performance Score.&#xD;
&#xD;
          -  Life expectancy ≥ 3 months.&#xD;
&#xD;
          -  Has adequate organ function.&#xD;
&#xD;
          -  Female participants of childbearing potential should have a negative pregnancy within&#xD;
             72 hours before the randomization. Male and female participants should agree to use an&#xD;
             adequate method of contraception during the experiment and 1 year after the last&#xD;
             administration of the test drugs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has squamous cell or undifferentiated gastric cancer.&#xD;
&#xD;
          -  Diagnosed additional maliganancy within 3 years prior to randomization with the&#xD;
             expection of curatively treated basal cell carcinoma of the skin, squamous cell&#xD;
             carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive&#xD;
             bladder cancers.&#xD;
&#xD;
          -  Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to the first dose&#xD;
             of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to&#xD;
             agents administered more than 4 weeks earlier.&#xD;
&#xD;
          -  Has had prior chemotherapy,radiation therapy or targeted small molecular therapy&#xD;
             within 2 weeks prior to the first dose of trial treatment or who has not recovered (≤&#xD;
             Grade 1 or at Baseline) from AEs due to a previously administrated agent.&#xD;
&#xD;
          -  Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-CTLA-4 agents.&#xD;
&#xD;
          -  Has known active central nervous system (CNS) metastases and/or carcinomatous&#xD;
             meningitis.&#xD;
&#xD;
          -  Has uncontrolled ascites, pleural effusion, or pericardial effusion.&#xD;
&#xD;
          -  Has active autoimmune disease that has required systemic treatment in past 2 years.&#xD;
&#xD;
          -  Has received a major surgery within 4 weeks prior to randomization.&#xD;
&#xD;
          -  Has received system treatment with corticosteroids (dose &gt;10mg/day prednison or other&#xD;
             therapeutic hormones) within 2 weeks prior to the first dose of trial treatment.&#xD;
&#xD;
          -  Has incomplete intestinal obstruction, active gastrointestinal hemorrhage and&#xD;
             perforation.&#xD;
&#xD;
          -  Has a history of non-infectious pneumonitis that required steriods or has current&#xD;
             pneumonitis.&#xD;
&#xD;
          -  Has any serious and/or uncontrolled disease.&#xD;
&#xD;
          -  Has active viral infection.&#xD;
&#xD;
          -  Has received a live vaccine within 30 days prior to the first dose of trial treatment.&#xD;
&#xD;
          -  Has participated in other anticancer drug clinical trials within 4 weeks.&#xD;
&#xD;
          -  According to the judgement of the investigators, there are other factors that may lead&#xD;
             to the termination of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jing Huang, MD</last_name>
    <phone>010-87788113</phone>
    <email>huangjingwg@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Anhui Provincial Cancer Hospital</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yifu He</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Anhui Provincial Hospital</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yueyin Pan</last_name>
    </contact>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhendong Chen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing ChaoYang Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guangyu An</last_name>
    </contact>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Jing Huang, MD</last_name>
      <email>huangjingwg@163.com</email>
    </contact>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Lin Zhao</last_name>
    </contact>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Bangwei Cao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Baoshan Cao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking University Internationale Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>102206</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Liang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chongqing University Cancer Hospital</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weiqing Chen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fujian Cancer Hospital</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>350000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rongbo Lin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gansu Wuwei Tumor Hospital</name>
      <address>
        <city>Wuwei</city>
        <state>Gansu</state>
        <zip>350000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rongbo Lin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Affiliated Cancer Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510095</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Chuan Jin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongshan People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>528403</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jianjun Xiao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking University Shenzhen Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518035</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shubin Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518117</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chunxia Du</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Guangxi Medical University Cancer Hospital</name>
      <address>
        <city>Naning</city>
        <state>Guangxi</state>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhihui Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangzhou</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sheng Ye</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Fourth Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shengmian Li</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050051</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Na Li</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Hebei University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>071000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aimin Zang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The affiliated Cancer Hospital of Harbin Medical University</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150081</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuxian Bai</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suxia Luo</last_name>
    </contact>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Qingxia Fan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Henan Science&amp;Technology University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>471000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xinshuai Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henan Provincial People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>540003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shundong Cang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Xiangya Hospital of Cancer South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xianling Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital, Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Shan Zeng</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410200</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xianli Yin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Affiliated People's Hospital of Inner Mongolia Medical University</name>
      <address>
        <city>Huhhot</city>
        <state>Inner Mongolia</state>
        <zip>010000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhenping Wen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Changzhou Cancer Hospital</name>
      <address>
        <city>Changzhou</city>
        <state>Jiangsu</state>
        <zip>213000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yang Ling</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jiangsu Provincial Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lingjun Zhu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nanjing Drum Tower Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yang Yang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongda Hospital Southeast Universtiy</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Cailian Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nantong Tumor Hospital</name>
      <address>
        <city>Nantong</city>
        <state>Jiangsu</state>
        <zip>226006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lei Yang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhixiang Zhuang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xuzhou Central Hospital</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <zip>221009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuan Yuan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Yangzhou FIrst People's Hospital</name>
      <address>
        <city>Yangzhou</city>
        <state>Jiangsu</state>
        <zip>225000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiandong Tong</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaojun Xiang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jiangxi Cancer Hospital</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yiye Wan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jilin Cancer Hospital</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ying Cheng</last_name>
    </contact>
  </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>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Wei Li</last_name>
    </contact>
  </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>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yunpeng Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Liaoning Cancer Hospital</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110042</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jingdong Zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>General Hospital of Ningxia Medical University</name>
      <address>
        <city>Yinchuan</city>
        <state>Ningxia</state>
        <zip>750001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ping Chen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shandong Provincial Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weibo Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shandong Cancer Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250117</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bo Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Qingdao University</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jing Lv</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Yantai Yuhuangding Hospital</name>
      <address>
        <city>Yantai</city>
        <state>Shandong</state>
        <zip>264000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ping Sun</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai General Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongxia Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Sixth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200233</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zan Shen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanxi Cancer Hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030013</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lu Wen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Enxiao Li</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sichuan Cancer Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin Lu</last_name>
    </contact>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Diansheng Zhong</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hubei Cancer Hospital</name>
      <address>
        <city>Hubei</city>
        <state>Wuhan</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xinjun Liang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xinjiang Medical University</name>
      <address>
        <city>Urumqi</city>
        <state>Xinjiang</state>
        <zip>830000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wenran Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xinjiang Medical University Cancer Hospital</name>
      <address>
        <city>Urumqi</city>
        <state>Xinjiang</state>
        <zip>830000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yong Tang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Yunnan Cancer Hospital</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650100</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Qing Bi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi Zheng</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhejiang Provincial People's Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310014</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liqin Lu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital, Medical School of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongming Pan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haijun Zhong</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Wenzhou Medical University</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhiming Huang</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>January 26, 2021</last_update_submitted>
  <last_update_submitted_qc>January 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2021</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>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irinotecan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04486651
org study id: HX008-III-GC-01
nct id: NCT04486651
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized, double-blinded, multicenter study to evaluate the efficacy and safety
      of HX008 injection combined with irinotecan versus placebo combined with irinotecan as
      second-line therapy in patients with adcanced gastric or gastroesophageal junction (GEJ)
      adenocarcinoma who have had tumor progression after first-line treatment with platinum and/or
      fluropyrimidine therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Overall Survival (OS) in All Participants
time frame: Up to approximately 36 months
description: OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm.
measure: Overall Survival (OS) in Participants With PD-L1 CPS≥1
time frame: Up to approximately 36 months
description: OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm with PD-L1 CPS≥1.
measure: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
time frame: Up to approximately 36 months
description: PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by investigators or death due to any cause, whichever occurs first.
measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
time frame: Up to approximately 36 months
description: ORR was defined as the percentage of participants who have a complete response (CR) or a partial response (PR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.
measure: Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
time frame: Up to approximately 36 months
description: DCR was defined as the percentage of participants who have a CR or a PR or a stable disease (SD), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.
measure: Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
time frame: Up to approximately 36 months
description: DOR was defined as the time from the first documented evidence of a response of CR or PR, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.
arm group label: HX008 plus Irinotecan
arm group type: Experimental
description: Participants recieve HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
arm group label: Placebo plus Irinotecan
arm group type: Placebo Comparator
description: Participants recieve placebo intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
intervention type: Drug
intervention name: Irinotecan Hydrochloride Injection
description: 160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle.
arm group label: HX008 plus Irinotecan
arm group label: Placebo plus Irinotecan
intervention type: Drug
intervention name: HX008
description: 200 mg administered as IV infusion on Day 1 of each 21-day cycle.
arm group label: HX008 plus Irinotecan
intervention type: Drug
intervention name: Placebo
description: Administered as IV infusion on Day 1 of each 21-day cycle.
arm group label: Placebo plus Irinotecan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jing Huang, MD
phone: 010-87788113
email: huangjingwg@163.com
facility: 
status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
contact: 
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status: Recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Irinotecan
sharing ipd: No