研究单位：[1]Shanghai Junshi Bioscience Co.,Ltd.[2]Suining Central Hospital Suining,Sichuan,China,629000[3]The First Affiliated Hospital of Bengbu Medical College Bengbu,Anhui,China,233300[4]The Peple's Hospital of Chizhou Chizhou,Anhui,China[5]Chinese PLA General Hospital Beijing,Beijing,China,100000[6]Beijing Hospital Beijing,Beijing,China,100005[7]Peking University People's hospital Beijing,Beijing,China,100044[8]Beijing Friendship Hospital,Capital Medical University Beijing,Beijing,China,100050[9]Beijing Cancer hospital Beijing,Beijing,China,510515[10]SiChuan Cancer Hospital Chengdu,Sichuan,China,610000
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). "
