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

Sponsor
Fudan University
Study ID
NCT06218810
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cadonilimab
  • Metastatic Colorectal Cancer
  • Microsatellite Stable Colorectal Carcinoma
  • RAS Mutation

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Jan 23, 2024
Start date
Jan 1, 2024
Status verified
Jan 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: single arm
    This study includes only on experimental arm

Primary Outcome Measure

1-year Progression Free Survival rate [ Time Frame: 12 months ]

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