研究单位：[1]Shanghai Junshi Bioscience Co., Ltd.[2]The Peple's Hospital of Chizhou Chizhou, Anhui, China[3]Chinese PLA General Hospital Beijing, Beijing, China, 100000[4]Beijing Hospital Beijing, Beijing, China, 100005[5]Peking University People's hospital Beijing, Beijing, China, 100044[6]Beijing Friendship Hospital, Capital Medical University Beijing, Beijing, China, 100050[7]Beijing Cancer hospital Beijing, Beijing, China, 510515[8]The first affiliated hospital of chongqing medical universit Chongqing, Chongqing, China, 400016[9]Fujian Provincial Cancer Hospital Fuzhou, Fujian, China, 350011[10]The First Affiliated Hospital of Xiamen University Xiamen, Fujian, China, 361003[11]Gansu Provincial People's Hospital Lanzhou, Gansu, China, 730000[12]Lanzhou University Second Hospital Lanzhou, Gansu, China, 730000[13]Gansu Provincial Cancer Hospital Lanzhou, Gansu, China, 730050[14]The first Hospital of Lanzhou University Lanzhou, Gansu, China, 750050[15]Wuwei Cancer Hospital of Gansu Province Wuwei, Gansu, China, 733000[16]Guandong General Hospital Guangzhou, Guandong, China, 510000[17]Zhujiang Hospital of Southern Medical University Guangzhou, Guandong, China, 510280[18]The First People's Hospital of Foshan Foshan, Guangdong, China, 528000[19]The First Affiliated Hospital of Sun yat-sen University Guangzhou, Guangdong, China, 510080[20]Affiliated Cancer Hospital and Institute of Ghuangzhou Medical University Guangzhou, Guangdong, China, 510095[21]Nanfang Hospital of Southern Medical University Guangzhou, Guangdong, China, 510515[22]Peking University Shenzhen Hospital Shenzhen, Guangdong, China, 518000[23]Shenzhen People's Hospital Shenzhen, Guangdong, China, 518000[24]Guangxi Medical University Affiliated Tumor Hospital Nanning, Guangxi, China, 530021[25]The Fourth Hospital of Hebei Medical University Shijiazhuang, Hebei, China, 050011河北医科大学第四医院[26]Harbin Medical University Cancer Hospital Harbin, Heilongjiang, China, 150081[27]Henan cancer hospital Zhengzhou, Henan, China, 450003[28]The First Affiliated Hospital of Zhengzhou University Zhengzhou, Henan, China, 450052[29]Union Hospital, Tongji Medical College,Huazhong University of Science and Technology Wuhan, Hubei, China, 430022[30]Hubei Cancer Hospital Wuhan, Hubei, China, 430079[31]Xiangya Hospital Central South University Changsha, Hunan, China, 410008[32]Hunan Cancer Hopital Changsha, Hunan, China, 410031[33]Jiangsu cancer hospital Nanjing, Jiangsu, China, 210000[34]The first Affiliated Hospital of Nanchang University Nanchang, Jiangxi, China, 330006[35]The Second Affiliated Hospital of Nanchang University Nanchang, Jiangxi, China, 330006[36]The First Hospital of Jilin University Changchun, Jilin, China, 130021[37]The First Hospital of China Medical University Shengyang, Liaoning, China, 110000[38]LiaoNing Cancer Hospital & Institute Shenyang, Liaoning, China, 110000[39]General Hospital of Ningxia Medical University Yinchuan, Ningxia, China, 750000[40]Qinghai University Affiliated Hosptial Xining, Qinghai, China, 810000[41]Jinan Central Hospital Jinan, Shangdong, China, 250012[42]Shandong Provincial Hospital Jinan, Shangdong, China, 250031[43]Affiliated Hospital of Jining Medical University Jining, Shangdong, China, 272007[44]Zhongshan Hospital, Fudan university Shanghai, Shanghai, China, 200032[45]Shanghai General Hospital Shanghai, Shanghai, China, 200080[46]Shanxi Provincial People's Hospital Taiyuan, Shanxi, China, 030012[47]Tangdu hospital, Air force Military Medical University Xian, Shanxi, China, 710000[48]Xijing hospital, Air force Military Medical University Xian, Shanxi, China, 710000[49]SiChuan Cancer Hospital Chengdu, Sichuan, China, 610000[50]Suining Central Hospital Suining, Sichuan, China, 629000[51]Cancer Hospital affiliated to Xinjiang Medical University Urumqi, Xinjiang, China, 830000[52]The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou, Zhejiang, China, 310009[53]The first affiliated hospital of Zhejiang medical university Hangzhou, Zhejiang, China[54]The Second Affiliated Hospital of Wenzhou Medical University Wenzhou, Zhejiang, China, 325024[55]The First Affiliated Hospital of Bengbu Medical College Bengbu, Anhui, China, 233300
研究目的：
"This is an international, multicenter, randomized, double-blind phase III study, plans to recruit 680 patients who received radical gastrectomy (R0, D2 or higher lymphadenectomy) with postoperative pathological stage II (T4aN0M0) or III (the 8th Edition American Joint Committee on Cancer [AJCC] Cancer Staging Manual) gastric adenocarcinoma and gastroesophageal junction adenocarcinoma, and the study intends to evaluate the efficacy and safety of JS001 combined with postoperative adjuvant chemotherapy versus placebo combined with postoperative adjuvant chemotherapy.
Patients meeting the inclusion criteria will be 1:1 randomized into JS001-chemotherapy group and placebo-chemotherapy group. The random stratification factors include adjuvant chemotherapeutic regimens (XELOX versus SOX) and tumor anatomical sites (gastric adenocarcinoma versus gastroesophageal junction adenocarcinoma). "
