This is a two-arm, randomized, double-blinded, multicenter phase III clinical study to evaluate the clinical efficacy of Serplulimab (HLX10) in Combination With Bevacizumab and Chemotherapy (XELOX) Versus Placebo in Combination With Bevacizumab and Chemotherapy (XELOX) in First-line Treatment of Patients With Metastatic Colorectal Cancer (mCRC)
Patients with confirmed unresectable metastatic/recurrent colorectal adenocarcinoma who have not received systemic anti-neoplastic therapy for metastatic/recurrent lesions will be included in this study.Approximately 6-12 patients will be enrolled in the Part I (Safety Run-in Period).Approximately 100 patients will be enrolled in the Part II (Phase II study, 50 in the test group and 50 in the control group).Approximately 568 patients will be enrolled in the Part III (Phase III study, 284 in the test group and 284 in the control group). Part II (Phase II study): Approximately 40 study sites in China will participate. Part III (Phase III study): A total of approximately 75 study sites in 3 countries(including China, Japan, Indonesia) will participate. The study consists of a screening period (up to 28 days), a treatment period (3-week cycle, up to 2 years), and a follow-up period (including a safety follow-up period, and a survival follow-up every 12 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
568
Center for Cancer Prevention and Treatment of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGLinyi Cancer Hospital
Linyi, China
RECRUITINGFudan University Affiliated Oncology Hospital
Shanghai, China
RECRUITINGNational Cancer Center
Kashiwa, Japan
NOT_YET_RECRUITINGPFS
Progression-free survival (assessed by independent radiological review committee (IRRC) based on RECIST v1.1)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
OS
Overall survival (OS)
Time frame: From date of randomization until the date of first date of death from any cause, assessed up to 100 months
PFS
Progression-free survival (assessed by the investigators based on RECIST v1.1)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
ORR
Objective response rate (assessed by independent radiological review and the investigators based on RECIST v1.1))
Time frame: through study completion, an average of 1 year
Duration of response
Duration of response
Time frame: from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed up to 2 years
DCR
Disease control rate
Time frame: the proportion of patients with the best overall response of CR, PR, or stable disease (SD) persisting for 12 weeks
PFS2
Progression-free survival in the next line of treatment(assessed by the investigators based on RECIST v1.1)
Time frame: From date of randomization until the date of the second documented PD as assessed by the investigator or date of death from any cause, whichever came first, assessed up to 100 months
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