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PD1 Combined With Chemotherapy for Adjuvant Treatment of Gastric Cancer
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Summary
This multicenter, randomized, double-blind phase III study intends to recruit about 878 patients, including PD-L1 positive 660 patients, who have received radical gastrectomy (R0 resection, D2 or more extended lymphadenectomy) with postoperative pathological stage IIB or III (AJCC Cancer Staging Manual, 8th Edition) gastric or EGJ adenocarcinoma to evaluate the efficacy and safety of JS001 combined with postoperative adjuvant chemotherapy versus placebo combined with postoperative adjuvant chemotherapy.
Official title: A Multicenter, Randomized, Double-Blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection Combined With Postoperative Adjuvant Chemotherapy Versus Placebo Combined With Postoperative Adjuvant Chemotherapy in Patients With Gastric or Esophagogastric Junction Adenocarcinoma After Radical Gastrectomy
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
878
Start Date
2022-02-10
Completion Date
2028-07-31
Last Updated
2025-01-15
Healthy Volunteers
No
Interventions
JS001/Placebo
JS001/placebo combine with Postoperative Adjuvant Chemotherapy
JS001/placebo combine with Postoperative Adjuvant Chemotherapy
JS001/placebo combine with Postoperative Adjuvant Chemotherapy
Locations (71)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
The Peple's Hospital of Chizhou
Chizhou, Anhui, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Peking University People's hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Cancer hospital
Beijing, Beijing Municipality, China
The first affiliated hospital of chongqing medical universit
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Gansu Provincial People's Hospital
Lanzhou, Gansu, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
The first Hospital of Lanzhou University
Lanzhou, Gansu, China
Wuwei Cancer Hospital of Gansu Province
Wuwei, Gansu, China
Guandong General Hospital
Guangzhou, Guandong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guandong, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
The First Affiliated Hospital of Sun yat-sen University
Guangzhou, Guangdong, China
Affiliated Cancer Hospital and Institute of Ghuangzhou Medical University
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Yuebei People's Hospital
Shaoguan, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The 2ed Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, China
Henan cancer hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Hunan Cancer Hopital
Changsha, Hunan, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Jiangsu cancer hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
The Second People's Hospital of Wuxi
Wuxi, Jiangsu, China
Jiangmen Central Hospital
Nanchang, Jiangxi, China
The first Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
The First Hospital of China Medical University
Shengyang, Liaoning, China
LiaoNing Cancer Hospital & Institute
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Qinghai University Affiliated Hosptial
Xining, Qinghai, China
Shandong Cancer Hospital
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Qingdao central medical group
Qingdao, Shandong, China
Jinan Central Hospital
Jinan, Shangdong, China
Shandong Provincial Hospital
Jinan, Shangdong, China
Affiliated Hospital of Jining Medical University
Jining, Shangdong, China
Zhongshan Hospital, Fudan university
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
Tangdu hospital, Air force Military Medical University
Xian, Shanxi, China
Xijing hospital, Air force Military Medical University
Xian, Shanxi, China
SiChuan Cancer Hospital
Chengdu, Sichuan, China
Suining Central Hospital
Suining, Sichuan, China
Cancer Hospital affiliated to Xinjiang Medical University
Ürümqi, Xinjiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The first affiliated hospital of Zhejiang medical university
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China