Combination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Colorectal Cancer

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT05171660
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Colorectal Cancer Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Sintilimab — DRUG
    Sintilimab Injection: 200 mg, i.v., D1, Q3W
  • Bevacizumab — DRUG
    intravenous bevacizumab (7.5 mg/kg, day 1) in each 21-day cycle
  • Oxaliplatin — DRUG
    intravenous oxaliplatin (130 mg/m2, day 1) in each 21-day cycle
  • Capecitabine — DRUG
    oral capecitabine (1 g/m2, days 1-14) in each 21-day cycle

Study Details

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.

Key Dates

First listed
Dec 29, 2021
Start date
Feb 8, 2022
Status verified
Feb 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
446 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sintilimab + XELOX + Bevacizumab
    Sintilimab + XELOX + Bevacizumab
  • Active Comparator: XELOX + Bevacizumab
    XELOX + Bevacizumab

Primary Outcome Measure

Progression free survival time [ Time Frame: From randomization to the first documented disease progression, or to death from any cause, up to 2 years ]

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