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Brief Title: HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer
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
Study ID: NCT04486651
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, China
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
Peking Union Medical College Hospital, Beijing, Beijing, China
Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, China
Peking University Third Hospital, Beijing, Beijing, China
Peking University Internationale Hospital, Beijing, Beijing, China
Chongqing University Cancer Hospital, Chongqing, Chongqing, 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, Huhhot, 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
Xuzhou Central Hospital, Xuzhou, 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, China
Shanghai Sixth People's Hospital, Shanghai, Shanghai, 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, China
Hubei Cancer Hospital, Hubei, Wuhan, China
The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China
Xinjiang Medical University Cancer Hospital, Urumqi, 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