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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
642
Peking University shenzhen hospital
Shenzhen, Guangdong, China
RECRUITINGAffiliated Hospital of Hebei University
Baoding, China
RECRUITINGBeijing Cancer Hospital
Beijing, China
RECRUITINGChina PLA General Hospital
Beijing, China
RECRUITINGPeking University International Hospital
Beijing, China
RECRUITINGPeking University Third Hospital
Beijing, China
RECRUITINGThe First Affiliated Hospital of Bengbu Medical College
Bengbu, China
RECRUITINGCangzhou People's Hospital
Cangzhou, China
RECRUITINGAnhui Provincial Hospital
Hefei, China
RECRUITINGThe First Affiliated Hospital of Anhui Medical University
Hefei, China
RECRUITING...and 5 more locations
EFS
event-free survival (assessed by independent radiological review committee (IRRC) based on RECIST v1.1)
Time frame: from randomizationuntil firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 3 years
EFS
Event-free survival (assessed by the investigator per RECIST v1.1 criteria)
Time frame: from randomizationuntil firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 3 years
DFS
Disease-free survival (assessed by the investigator per RECIST v1.1 criteria)
Time frame: from the start of surgery to disease recurrence or death (for any reason),assessed up to 3 years
pCR rate
Pathological complete response (pCR) rate (assessed by central pathology laboratory and the site)
Time frame: after surgery,an average of 6 months
5-year OS rate
5-year overall survival (OS) rate
Time frame: OS is the time from randomization to death (of any cause),assessed up to 5 years
Lin Shen
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