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Recruiting Phase 2 NCT06280105

NCT06280105 A Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Failed Camrelizumab Combined With Apatinib

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Clinical Trial Summary
NCT ID NCT06280105
Status Recruiting
Phase Phase 2
Sponsor Meng Chao Hepatobiliary Hospital of Fujian Medical University
Condition Hepatocellular Carcinoma
Study Type INTERVENTIONAL
Enrollment 40 participants
Start Date 2024-03-31
Primary Completion 2026-03-31

Trial Parameters

Condition Hepatocellular Carcinoma
Sponsor Meng Chao Hepatobiliary Hospital of Fujian Medical University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-03-31
Completion 2026-03-31
Interventions
Cadonilimab+regorafenib

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Brief Summary

To evaluate the efficacy and safety of cadonilimab combined with Regorafenib in patients with hepatocellular carcinoma who failed camrelizumab plus apatinib.

Eligibility Criteria

Inclusion Criteria: 1. Sign a written informed consent form before enrollment; 2. Age \>18 years old, both sex; 3. Histological or pathological confirmed intermediate or advanced hepatocellular carcinoma, or patients with cirrhosis who meet the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Study of Liver Diseases (AASLD); 4. Have progressed on the combination treatment of camrelizumab and apatinib for HCC 5. Child-Pugh Class A; 6. ECOG PS score: 0\~1; 7. At least 1 measurable lesion (RECIST1.1) 8. Expected survival period≥12 weeks 9. The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days): 1\. Blood routine: Neutrophils≥1.5×109/L Platelet count ≥75×109/L Hemoglobin ≥ 90g/L; 2. Liver and kidney function: Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBI

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