A Study of Cadonilimab Combined With AK112 as Second-line Therapy in Patients With Advanced Hepatocellular Carcinoma

A Single-arm, Single-center, Phase II Clinical Trial of Cadonilimab (Anti PD-1/CTLA-4) Combined With AK112 (Anti VEGF/PD-1) as Second-line Therapy in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Hepatocellular Carcinoma

To evaluate the efficacy and safety of cadonilimab combined with AK112 as second-line therapy in patients with advanced hepatocellular carcinoma.

Inclusion Criteria:

• Histopathologically confirmed HCC
• Age 18-75 years old
• ECOG PS 0-1
• Child Pugh A-B7
• Patients who progressed on first-line standard system therapy (immunotherapy combined with Anti-angiogenesis targeting regimen) or with intolerable toxicity
• At least one measurable lesion (RECIST 1.1)
• Enough organ and bone marrow function
• Expected survival time≥12 weeks
• Sign a written informed consent and be able to comply with the visit and related procedures required by the study protocol

Exclusion Criteria:

• Severe complications due to primary liver disease
• No prior systemic therapy for advanced or metastatic primary hepatocellular carcinoma
• Malignant diseases other than primary hepatocellular carcinoma were diagnosed within 5 years prior to first administration
• Previous treatment with drugs that synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137)
• Autoimmune immune disease
• History of HIV
• Prognent women
• The presence of any serious or uncontrolled systemic disease
• Medical history or evidence of disease that may interfere with the test results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment. The Investigator considers that there are other potential risks that are not suitable for participation in the study.