RecruitingPhase 2NCT05970302

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

XELOX and Bevacizumab in Combination With Tislelizumab for First-Line Treatment of Patients With MSS/pMMR RAS-mutated Metastatic Colorectal Cancer (mCRC): A Single-arm, Phase II Study.


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

52 participants

Start Date

Jul 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — XELOX chemotherapy (capecitabine plus oxaliplatin) together with bevacizumab (a drug that blocks blood vessel growth in tumors) and tislelizumab (an immunotherapy drug) — as a first-line treatment for metastatic colorectal cancer that cannot be surgically removed. The cancer must have specific molecular features: MSS/pMMR type (meaning standard immunotherapy alone is not expected to work) and RAS mutations. **You may be eligible if...** - You have confirmed metastatic colorectal cancer with MSS/pMMR and RAS mutation status - You have not previously received chemotherapy for metastatic disease - You have at least one measurable tumor on imaging - You are physically well enough to carry out most daily activities (ECOG 0–1) - Your blood counts and organ function are within required ranges - You are able to swallow oral medications **You may NOT be eligible if...** - Your cancer is resectable (can be surgically removed) - You have already received systemic treatment for metastatic disease - Your tumor is MSI-high (this subtype responds to immunotherapy differently) - You have serious heart or organ disease that would make treatment unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab+Bevacizumab+Oxaliplatin+Capecitabine

Use the above medications on a regular basis.


Locations(1)

Lin Yang

Beijing, China

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NCT05970302


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