研究单位：[1]Shanghai Henlius Biotech[2]Affiliated Hospital of Hebei University Baoding, China[3]Beijing Cancer Hospital Beijing, China[4]China PLA General Hospital Beijing, China[5]Peking University International Hospital Beijing, China[6]Peking University Third Hospital Beijing, China[7]The First Affiliated Hospital of Bengbu Medical College Bengbu, China[8]Cangzhou People's Hospital Cangzhou, China[9]Anhui Provincial Hospital Hefei, China[10]The First Affiliated Hospital of Anhui Medical University Hefei, China[11]Linyi Cancer Hospital Linyi, China[12]The Fourth Hospital of Hebei Medical University Shijia Zhuang, China河北医科大学第四医院[13]Shanxi Provincial People's Hospital Taiyuan, China[14]Tianjin Medical University Institute & Hospital Tianjin, China[15]Xingtai People's Hospital Xingtai, China[16]Peking University shenzhen hospital Shenzhen, Guangdong, 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.
