研究单位：[1]Suzhou Suncadia Biopharmaceuticals Co.,Ltd.[2]The First Affiliated Hospital of Bengbu Medical College Bengbu,Anhui,China,233004[3]The Second Affiliated Hospital Of Anhui Medical University Hefei,Anhui,China,230601[4]Sichuan Cancer Hospital & Institute Chengdu,Sichuan,China,610042[5]Fujian Medical University Union Hospital Fuzhou,Fujian,China,350000[6]Fujian Medical University Union Hospital Fuzhou,Fujian,China,350000[7]The First Affiliated Hospital,Sun Yat-sen University Guangzhou,Guangdong,China,510000[8]The Fourth Hospital of Hebei Medical University Shijiazhuang,Hebei,China,050000[9]Xingtai People's Hospital Xingtai,Hebei,China,054031[10]Anyang Cancer Hospital Anyang,Henan,China,455000
研究目的：
This is a multi-center phase II/III clinical study consisting of two stages: Stage I is a single-arm open-label phase II study to preliminarily explore the efficacy and safety of SHR-1701 plus S-1 and oxaliplatin mainly by the endpoint of pCR rate.
Stage II is a randomized,double-blind,multi-center phase III study of SHR-1701 plus S-1 and oxaliplatin versus placebo plus S-1 and oxaliplatin as perioperative treatment in subjects with resectable GC or GEJC. A total of 846 treatment naïve subjects will be enrolled,and primary endpoint of this stage is Independent Review Committee (IRC)-assessed EFS.
