研究单位：[1]Shanghai Henlius Biotech[2]Peking University shenzhen hospital,Shenzhen,Guangdong,China[3]Affiliated Hospital of Hebei University,Baoding,China[4]Beijing Cancer Hospital,Beijing,China[5]China PLA General Hospital,Beijing,China[6]Peking University International Hospital,Beijing,China[7]Peking University Third Hospital,Beijing,China[8]The First Affiliated Hospital of Bengbu Medical College,Bengbu,China[9]Cangzhou People's Hospital,Cangzhou,China[10]Anhui Provincial Hospital,Hefei,China[11]The First Affiliated Hospital of Anhui Medical University,Hefei,China[12]Linyi Cancer Hospital,Linyi,China[13]The Fourth Hospital of Hebei Medical University,Shijia Zhuang,China[14]Shanxi Provincial People's Hospital,Taiyuan,China[15]Tianjin Medical University Institute & Hospital,Tianjin,China[16]Xingtai People's Hospital,Xingtai,China
研究目的：
This is a two-arm, randomized, double-blinded, multicenter phase III clinical study to evaluate the efficacy of HLX10 combined with chemotherapy versus placebo combined with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer. Subjects will be randomized to the following two arms at 1: 1 ratio: - Arm A (HLX10 arm): HLX10 combined with chemotherapy will be adopted in the neoadjuvant treatment phase, and HLX10 monotherapy will be administered in the adjuvant treatment phase; - Arm B (control arm): Placebo combined with chemotherapy will be given in the neoadjuvant treatment phase, and chemotherapy alone will be administered during the adjuvant treatment phase. Chemotherapy regimen SOX (oxaliplatin + tegafor gimeracil oteracil potassium (S-1)) will be used in the neoadjuvant treatment phase in Arm A and B, and in the adjuvant treatment phase in Arm B. After randomization, subjects will receive a total of 3 cycles of neoadjuvant treatment with the mentioned treatment regimen.Surgery will be performed within 3-6 weeks after the last cycle of neoadjuvant treatment.All subjects who have completed the surgery will be unblinded after surgery, and adjuvant treatment will be started 3 to 12 weeks after surgery. Subjects randomized to Arm A (HLX10 arm) will continue to receive HLX10 monotherapy for up to 17 cycles (12 months).Subjects in Arm B after surgery (control arm) will continue to use chemotherapy alone (oxaliplatin + S-1) for 5 cycles.
