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

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.