RecruitingPhase 2NCT06282445

Efficacy and Safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer

Efficacy and Safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer: a Prospective, Multicenter, Single-arm Study


Sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Enrollment

36 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy and safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding adebrelimab (an immunotherapy drug) to a standard chemotherapy regimen (XELOX: oxaliplatin + capecitabine) combined with bevacizumab (a drug that blocks tumor blood vessel growth) improves outcomes as a first-line treatment for people with metastatic colorectal cancer that has a specific molecular profile (MSS/pMMR) and cannot be surgically removed. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed metastatic colorectal cancer that cannot be surgically removed - Your tumor has been tested and is MSS (microsatellite stable) or pMMR - You have at least one measurable tumor site - You are in good physical condition (ECOG 0-1) with at least 12 weeks expected survival - Your blood counts, liver, kidney, and thyroid function are adequate **You may NOT be eligible if...** - You have already received chemotherapy for metastatic colorectal cancer - You have autoimmune conditions requiring treatment - You are pregnant or breastfeeding - You have significant heart or lung disease 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

DRUGAdebrelimab

This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 1200mg, administered every 3 Weeks (Q3W).

DRUGOxaliplatin

130 mg/m2, ivgtt, d1, Q3W

DRUGCapecitabine

1000mg/m2, po, bid, d1-14, Q3W Maintenance therapy: 1250mg/m2, po, bid, d1-14, Q3W

DRUGBevacizumab

7.5mg/kg,ivgtt, d1, Q3W


Locations(1)

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Jinhua, Zhejiang, China

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NCT06282445


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