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

Akeso

Status and phase

Completed

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Anlotinib Hydrochloride

Biological: AK105

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04172571

AK105-203

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.