NCT06566755

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Caigang Liu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-02-01
• Completion: 2027-02-01
• First posted: 2024-08-22
• Last updated: 2024-08-22

Locations

1 site across 1 country: China