RecruitingPhase 2NCT06218810

Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer

Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer: A Single-Arm, Open-Label, Multicenter Phase II Study


Sponsor

Fudan University

Enrollment

53 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The dual immunotherapy regimen significantly outperformed previous chemotherapy or immunomonotherapy for MSS type advanced CRC in two key efficacy indicators, ORR and PFS. Researchers have also conducted in-depth analysis of patient transcriptomics, immune microenvironment characteristics, and other related information, which is expected to guide more accurate immune combination therapy for CRC in the future. Our team plans to conduct a multicenter, prospective, single arm clinical trial in patients with RAS mutant MSS unresectable metastatic colorectal cancer, with a focus on observing the 1-year progression free survival rate of the combination of two chemotherapy drugs, bevacizumab and Cadonilimab, as well as ORR, perioperative safety, and long-term survival.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of cadonilimab (an immunotherapy drug targeting PD-1 and CTLA-4), bevacizumab (an anti-angiogenic drug), and FOLFOX chemotherapy as a first-line treatment for patients with advanced colorectal cancer that has specific genetic features (MSS-type and RAS-mutated) — a group typically resistant to standard immunotherapy. **You may be eligible if...** - You are aged 18–75 with confirmed metastatic colorectal adenocarcinoma - Your tumor is MSS (microsatellite stable) and has a RAS mutation - You have not received any prior systemic treatment for your metastatic disease - You have at least one measurable tumor and are in good overall health (ECOG 0–1) **You may NOT be eligible if...** - Your tumor is MSI-H (high microsatellite instability) or RAS wild-type - You have had prior immunotherapy (checkpoint inhibitors) - You have another active cancer within the past 3 years (with some exceptions) - You have had prior chemotherapy within 3 weeks of starting the study 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

DRUGCadonilimab + bevacizumab + FOLFOX

Cadonilimab + bevacizumab + FOLFOX


Locations(1)

Zhongshan hosptial, Fudan University

Shanghai, China

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NCT06218810


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