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NCT05171660
PHASE3

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

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Open, Multicenter Phase III Clinical Trial of Combination of Sintilimab Injection (IBI308) and XELOX+Bevacizumab Compared With XELOX+Bevacizumab as 1st Line Therapy of RAS-Mutant Metastatic Colorectal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

446

Start Date

2022-02-08

Completion Date

2026-12-30

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

DRUG

Sintilimab

Sintilimab Injection: 200 mg, i.v., D1, Q3W

DRUG

Bevacizumab

intravenous bevacizumab (7.5 mg/kg, day 1) in each 21-day cycle

DRUG

Oxaliplatin

intravenous oxaliplatin (130 mg/m2, day 1) in each 21-day cycle

DRUG

Capecitabine

oral capecitabine (1 g/m2, days 1-14) in each 21-day cycle

Locations (1)

Xuefeng Fang

Hangzhou, Zhejiang, China