XELOX +Bev +Tislelizumab for First-line Treatment of MSS/pMMR RAS-mutated mCRC

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT05970302
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bevacizumab
  • Capecitabine
  • First-Line
  • MSS/pMMR
  • Metastatic Colorectal Cancer (mCRC)
  • Oxaliplatin
  • RAS-mutated
  • Tislelizumab

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The goal of this clinical trial is to compare XELOX +Bev +Tislelizumab with standard chemotherapy，in MSS/pMMR-type RAS-mutated metastatic colorectal adenocarcinoma. The main questions it aims to answer are efficacy and safety of the regimen of XELOX +Bev +Tislelizumab. The investigators want to transform ras-mutated colorectal cancer into a "hot tumor" through the combination of anti-vascular therapy and chemotherapy, and then achieve better therapeutic effect through the combination with immunotherapy. Participants will receive the regimen of XELOX +Bev +Tislelizumab.

Key Dates

First listed
Aug 1, 2023
Start date
Jul 7, 2023
Status verified
Jul 2023
Primary completion
Jul 31, 2025
Completion
Jul 31, 2026

Study Design

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

Arms

  • Experimental: XELOX +Bev +Tislelizumab
    Every 3 weeks as a cycle: 1. Tislelizumab: 200mg, iv, d1; 2. Bevacizumab: 7.5mg/kg, iv, d1; 3. Oxaliplatin: 130mg/m2, iv, d1; 4. Capecitabine: 1000mg/m2, bid, po, d1-d14; Re-evaluate patients every two cycles. If the patient has been treated for more than 8 cycles, they will enter maintenance therapy, and the regimen is capecitabine + BEV combined with tislelizumab.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 2 years ]

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