A Study of the Combination of Anti-PD-1 AK105 and Anlotinib in First-line Hepatocellular Carcinoma (HCC)

An Open-Label Multi-Center Phase Ib/II Study of the Combination of AK105 and Anlotinib Hydrochloride in the First-Line Treatment of Patients With Unresectable Hepatocellular Carcinoma

This is a multi-center,open-label study to evaluate the efficacy and safety of anti-PD-1 antibody AK105 plus anlotinib hydrochloride in the first-line treatment of patients with unresectable hepatocellular carcinoma.

Inclusion Criteria:

• Signed written informed consent form voluntarily.
• Male or female，age over 18 years old (inclusive) and not more than 75 years old (inclusive), when signing the ICF.
• Expected life expectance ≥ 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
• Confirmation either by histology unresectable hepatocellular carcinoma..
• BCLC stage C, and non-resectable BCLC stage B .
• No prior systemic therapy for HCC.
• Child-Pugh class A and B (≤7 points).
• At least one measurable lesion according to RECIST criteria.
• Adequate hematologic and end-organ function.
• For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent.

Exclusion Criteria:

• Prior treatment with anti-PD1, anti-PD-L1 or anti-CTLA-4 antibody therapy.
• Active ongoing infection requiring therapy.
• History of severe hypersensitivity reaction to another monoclonal antibody.
• Received any live attenuated vaccine within the last 30 days.
• Other malignancy requiring treatment in the prior 5 years with the exception of locally treated squamous or basal cell carcinoma.
• Pregnant, breast feeding, or planning to become pregnant.
• Active or prior documented autoimmune or inflammatory disease with some exceptions.
• Central nervous system metastases and/or carcinomatous meningitis.
• Medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication.
• Co-infection of HBV and HCV.
• Inadequately controlled arterial hypertension.