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

• Status: Active, not recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akeso
• Collaborator: Akeso Tiancheng, Inc

Criteria

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.