A Study of the Combination of Anti-PD-1 AK105 and Anlotinib in First-line Hepatocellular Carcinoma (HCC)
NCT04172571 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2024-05-30
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.
Conditions
Interventions
- BIOLOGICAL
-
AK105
Anti-PD-1 antibody; IV infusion, 200 mg Q3W
- DRUG
-
Anlotinib Hydrochloride
multi-targeted receptor TKI; oral administration; every 3 weeks as one cycle administered as 2 weeks on/1 week off
Sponsors & Collaborators
-
Akeso Tiancheng, Inc
collaborator OTHER - lead INDUSTRY
Principal Investigators
-
Shunchang Jiao, MD · Chinese PLA General Hospital
-
Li Bai, 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
- 2018-11-22
- Primary Completion
- 2022-06-01
- Completion
- 2022-07-08
- FDA Drug
- Yes
Countries
- China
Study Locations
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