HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer
NCT ID: NCT04486651
Last Updated: 2021-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
560 participants
INTERVENTIONAL
2020-09-16
2023-08-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HX008 plus Irinotecan
Participants recieve HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
Irinotecan Hydrochloride Injection
160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle.
HX008
200 mg administered as IV infusion on Day 1 of each 21-day cycle.
Placebo plus Irinotecan
Participants recieve placebo intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
Irinotecan Hydrochloride Injection
160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle.
Placebo
Administered as IV infusion on Day 1 of each 21-day cycle.
Interventions
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Irinotecan Hydrochloride Injection
160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle.
HX008
200 mg administered as IV infusion on Day 1 of each 21-day cycle.
Placebo
Administered as IV infusion on Day 1 of each 21-day cycle.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 and ≤ 75 years old, male or female.
* Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ).
* Has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing platinum and/or fluoropyrimidine therapy.
* Willing to provide tissue for PD-L1 biomarker analysis.
* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.
* Life expectancy ≥ 3 months.
* Has adequate organ function.
* Female participants of childbearing potential should have a negative pregnancy within 72 hours before the randomization. Male and female participants should agree to use an adequate method of contraception during the experiment and 1 year after the last administration of the test drugs.
Exclusion Criteria
* Diagnosed additional maliganancy within 3 years prior to randomization with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers.
* Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to agents administered more than 4 weeks earlier.
* Has had prior chemotherapy,radiation therapy or targeted small molecular therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to a previously administrated agent.
* Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-CTLA-4 agents.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has uncontrolled ascites, pleural effusion, or pericardial effusion.
* Has active autoimmune disease that has required systemic treatment in past 2 years.
* Has received a major surgery within 4 weeks prior to randomization.
* Has received system treatment with corticosteroids (dose \>10mg/day prednison or other therapeutic hormones) within 2 weeks prior to the first dose of trial treatment.
* Has incomplete intestinal obstruction, active gastrointestinal hemorrhage and perforation.
* Has a history of non-infectious pneumonitis that required steriods or has current pneumonitis.
* Has any serious and/or uncontrolled disease.
* Has active viral infection.
* Has received a live vaccine within 30 days prior to the first dose of trial treatment.
* Has participated in other anticancer drug clinical trials within 4 weeks.
* According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
18 Years
75 Years
ALL
No
Sponsors
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Taizhou Hanzhong biomedical co. LTD
INDUSTRY
Responsible Party
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Locations
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Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing ChaoYang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Peking University Internationale Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Xiamen, Fujian, China
Gansu Wuwei Tumor Hospital
Wuwei, Gansu, China
Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Zhongshan People's Hospital
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, China
Guangxi Medical University Cancer Hospital
Naning, Guangxi, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangzhou, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Affiliated Hospital of Hebei University
Shijiazhuang, Hebei, China
The affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The First Affiliated Hospital of Henan Science&Technology University
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The Second Xiangya Hospital of Cancer South University
Changsha, Hunan, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Affiliated People's Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Changzhou Cancer Hospital
Changzhou, Jiangsu, China
Jiangsu Provincial Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Zhongda Hospital Southeast Universtiy
Nanjing, Jiangsu, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Yangzhou FIrst People's Hospital
Yangzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Shandong Provincial Hospital
Jinan, Shandong, China
Shandong Cancer Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Hubei Cancer Hospital
Hubei, Wuhan, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Xinjiang Medical University Cancer Hospital
Ürümqi, Xinjiang, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Medical School of Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Yifu He
Role: primary
Yueyin Pan
Role: primary
Zhendong Chen
Role: primary
Guangyu An
Role: primary
Lin Zhao
Role: primary
Bangwei Cao
Role: primary
Baoshan Cao
Role: primary
Jun Liang
Role: primary
Weiqing Chen
Role: primary
Rongbo Lin
Role: primary
Rongbo Lin
Role: primary
Chuan Jin
Role: primary
Jianjun Xiao
Role: primary
Shubin Wang
Role: primary
Chunxia Du
Role: primary
Zhihui Liu
Role: primary
Sheng Ye
Role: primary
Shengmian Li
Role: primary
Na Li
Role: primary
Aimin Zang
Role: primary
Yuxian Bai
Role: primary
Suxia Luo
Role: primary
Qingxia Fan
Role: primary
Xinshuai Wang
Role: primary
Shundong Cang
Role: primary
Xianling Liu
Role: primary
Shan Zeng
Role: primary
Xianli Yin
Role: primary
Zhenping Wen
Role: primary
Yang Ling
Role: primary
Lingjun Zhu
Role: primary
Yang Yang
Role: primary
Cailian Wang
Role: primary
Lei Yang
Role: primary
Zhixiang Zhuang
Role: primary
Yuan Yuan
Role: primary
Jiandong Tong
Role: primary
Xiaojun Xiang
Role: primary
Yiye Wan
Role: primary
Ying Cheng
Role: primary
Wei Li
Role: primary
Yunpeng Liu
Role: primary
Jingdong Zhang
Role: primary
Ping Chen
Role: primary
Weibo Wang
Role: primary
Bo Liu
Role: primary
Jing Lv
Role: primary
Ping Sun
Role: primary
Hongxia Wang
Role: primary
Zan Shen
Role: primary
Lu Wen
Role: primary
Enxiao Li
Role: primary
Jin Lu
Role: primary
Diansheng Zhong
Role: primary
Xinjun Liang
Role: primary
Wenran Wang
Role: primary
Yong Tang
Role: primary
Qing Bi
Role: primary
Yi Zheng
Role: primary
Liqin Lu
Role: primary
Hongming Pan
Role: primary
Haijun Zhong
Role: primary
Zhiming Huang
Role: primary
Other Identifiers
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HX008-III-GC-01
Identifier Type: -
Identifier Source: org_study_id
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