OncoMatch

OncoMatch/Clinical Trials/NCT06218810

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

Is NCT06218810 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cadonilimab + bevacizumab + FOLFOX for metastatic colorectal cancer.

Phase 2RecruitingFudan UniversityNCT06218810Data as of May 2026

Treatment: Cadonilimab + bevacizumab + FOLFOXThe 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.

Check if I qualify

Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Required: RAS mutation

RAS mutation

Required: MMR proficient

pMMR

Required: MSI microsatellite stable

MSS

Excluded: RAS wild-type

Participants of RAS wild-type [excluded]

Excluded: MMR deficient

dMMR [excluded]

Excluded: MSI microsatellite instability-high

MSI-H [excluded]

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systematic anti-tumor therapy

Colorectal cancer patients who have not received systematic anti-tumor therapy in the past

Cannot have received: systematic anti-tumor therapy (chemotherapy)

Exception: within 3 weeks prior to the first administration

Received systematic anti-tumor therapy (chemotherapy) within 3 weeks prior to the first administration

Cannot have received: immunotherapy against tumors

Have received any immunotherapy against tumors in the past, including immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, and any treatment targeting the immune mechanism of tumors

Cannot have received: non-specific immunomodulatory therapy (interleukin, interferon, thymosin)

Exception: excluding IL-11 used to treat thrombocytopenia; within 2 weeks before the first administration

Received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc., excluding IL-11 used to treat thrombocytopenia) within 2 weeks before the first administration

Cannot have received: Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications

Exception: within 1 week before the first administration

Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications was received within 1 week before the first administration

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify