A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Plus Lenvatinib in First-line Advanced Hepatocellular Carcinoma
NCT04444167 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2024-04-25
Summary
An open-label multi-center phase Ib/II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 plus lenvatinib as the first-line therapy for patients with advanced hepatocellular carcinoma.
Conditions
Interventions
- BIOLOGICAL
-
AK104
Subjects will receive AK104 and lenvatinib until disease progression or for a maximum of 24 months
- DRUG
-
Subjects will receive AK104 and lenvatinib until disease progression for a maximum of 24 months
Sponsors & Collaborators
-
Akeso Pharmaceuticals, Inc.
collaborator OTHER - lead INDUSTRY
Principal Investigators
-
Li Bai, MD · Chinese PLA General Hospital
-
Shunchang Jiao, MD · Chinese PLA General Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-07
- Primary Completion
- 2023-11-20
- Completion
- 2023-11-20
Countries
- China
Study Locations
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