Sintilimab (IBI308) Combined With Bevacizumab + XELOX Regimen in Metastatic Colorectal Cancer

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT04194359
Phase
PHASE2
Status
Unknown

Conditions

  • Metastatic Colorectal Cancer
  • Microsatellite Stable
  • RAS Mutation

Eligibility Criteria

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

Interventions

Study Details

A phase II clinical study of Sintilimab (IBI308) combined with Bevacizumab, Oxaliplatin and Capecitabine regimen as first-line treatment in patients with RAS-mutant and microsatellite stable metastatic colorectal cancer. A total of 25 patients are planned to be enrolled.

Key Dates

First listed
Dec 11, 2019
Start date
Feb 4, 2021
Status verified
Mar 2023
Primary completion
Nov 30, 2022
Completion
Dec 12, 2023

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sintilimab (IBI308) plus Bevacizumab, Oxaliplatin and Capecitabine
    Sintilimab (IBI308)：200MG, once every three weeks; Bevacizumab:7.5mg/kg, once every three weeks; oxplatin: 135 mg per square meter body surface, once every three weeks; Capecitabine : Capecitabine 1 gram per square meter body surface area, from the first day to the 14th day

Primary Outcome Measure

Objective Response Rate [ Time Frame: From Baseline to disease progress, up to 18 months ]

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