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

Harbin Medical University

Status and phase

Not yet enrolling

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Biological: AK104+AK112

Study type

Interventional

Funder types

Other

Identifiers

AK104-IIT-042

Details and patient eligibility

About

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

Enrollment

36 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.