Cadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer

Sponsor
Caigang Liu
Study ID
NCT06566755
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Cadonilimab (AK104) combined with chemotherapy and bevacizumab — DRUG
    Participants receive Cadonilimab PLUS chemotherapy and bevacizumab of each 21-day cycle. Treatment period (4-8 cycles)： * Cadonilimab: 10mg/kg, intravenous infusion, D1, Q3W; * CapeOx chemotherapy regimen Q3W+ bevacizumab, Q3W: oxaliplatin: 130 mg/m2 intravenous infusion, D1, Q3W; capecitabine: 850 mg/m2 orally, D1-14, Q3W, twice daily; bevacizumab injection: 7.5mg/kg, IV, D1, Q3W. Maintenance treatment period： * Cadonilimab: 10mg/kg, administered D1, Q3W; * capecitabine: 1000 mg/m2 orally, D1-14, Q3W, twice daily; * bevacizumab injection: 7.5mg/kg, IV, D1, Q3W.

Study Details

The purpose of this study is to assess the efficacy and safety of Cadonilimab (AK104) combined with chemotherapy and bevacizumab as first-line treatment for patients with RAS mutated or right sided-metastatic MSS colorectal cancer

Key Dates

First listed
Aug 22, 2024
Start date
Feb 1, 2024
Status verified
Aug 2024
Primary completion
Feb 1, 2026
Completion
Feb 1, 2027

Study Design

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

Arms

  • Experimental: Cadonilimab (AK104) combined with chemotherapy and bevacizumab
    Participants receive Cadonilimab PLUS chemotherapy and bevacizumab of each 21-day cycle. Treatment period (4-8 cycles)： * Cadonilimab: 10mg/kg, intravenous infusion, D1, Q3W; * CapeOx chemotherapy regimen Q3W+ bevacizumab, Q3W: oxaliplatin: 130 mg/m2 intravenous infusion, D1, Q3W capecitabine: 850 mg/m2 orally, D1-14, Q3W, twice daily; bevacizumab injection: 7.5mg/kg, IV, D1, Q3W. Maintenance treatment period： * Cadonilimab: 10mg/kg, administered D1, Q3W; * capecitabine: 1000 mg/m2 orally, D1-14, Q3W, twice daily; * bevacizumab injection: 7.5mg/kg, IV, D1, Q3W.

Primary Outcome Measure

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator [ Time Frame: Up to approximately 1 year ]

Central Contacts

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