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

NCT05171660 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

  • Colorectal Cancer Stage IV

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

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Ying Yuan · 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05171660 on ClinicalTrials.gov