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Brief Title: A Clinical Study of HLX10 Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer
Official Title: A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer
Study ID: NCT04139135
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Peking University shenzhen hospital, Shenzhen, Guangdong, China
Affiliated Hospital of Hebei University, Baoding, , China
Beijing Cancer Hospital, Beijing, , China
China PLA General Hospital, Beijing, , China
Peking University International Hospital, Beijing, , China
Peking University Third Hospital, Beijing, , China
The First Affiliated Hospital of Bengbu Medical College, Bengbu, , China
Cangzhou People's Hospital, Cangzhou, , China
Anhui Provincial Hospital, Hefei, , China
The First Affiliated Hospital of Anhui Medical University, Hefei, , China
Linyi Cancer Hospital, Linyi, , China
The Fourth Hospital of Hebei Medical University, Shijia Zhuang, , China
Shanxi Provincial People's Hospital, Taiyuan, , China
Tianjin Medical University Institute & Hospital, Tianjin, , China
Xingtai People's Hospital, Xingtai, , China