Sintilimab (R\&D code: IBI308) is a recombinant human-derived IgG4 type PD-1 monoclonal antibody. PD-1 inhibitor combined with chemotherapy has synergistic effect to further enhance anti-tumor immunity. This study is a phase III clinical study of a three-week regimen of sintilimab combined with the XELOX+ bevacizumab for RAS-mutant metastatic colorectal cancer patients who had not received any treatment before. The purpose of this study is to explore the efficacy of sintilimab combined with XELOX + bevacizumab as first line therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
446
Sintilimab Injection: 200 mg, i.v., D1, Q3W
intravenous bevacizumab (7.5 mg/kg, day 1) in each 21-day cycle
intravenous oxaliplatin (130 mg/m2, day 1) in each 21-day cycle
oral capecitabine (1 g/m2, days 1-14) in each 21-day cycle
Xuefeng Fang
Hangzhou, Zhejiang, China
Progression free survival time
Progression-free survival is defined as the time from randomization to the first documented disease progression according to RECIST version 1.1, or to death from any cause, whichever occurred first.
Time frame: From randomization to the first documented disease progression, or to death from any cause, up to 2 years
Objective Response Rate
According to RECIST 1.1 criteria, the proportion of patients whose tumor efficacy was evaluated as CR and PR among all evaluable patients
Time frame: From randomization to disease progression
Overall survival time
Time from randomization to death from any cause
Time frame: From randomization to death from any cause, up to 3 years
Disease control rate
According to RECIST 1.1 criteria, the proportion of subjects whose tumor efficacy was evaluated as CR, PR and SD among all evaluable patients
Time frame: From randomization to disease progression
Clinical benefit rate
The proportion of patients who achieved CR PR or maintained SD for a certain period of time (6 months)
Time frame: From randomization to disease progression
Adverse Events
Incidence of AEs (all grades), incidence of grade 1-2 AEs, incidence of grade 3-4 AEs, incidence of grade 5 AEs, treatment discontinuation rate, discontinuation rate due to adverse reactions, all subjects who used at least one study drug were included
Time frame: From randomization to 28 days after disease progression
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