TACE Combined with Sintilimab Plus Bevacizumab Biosimilar in Patients with Advanced Hepatocellular Carcinoma (TASK-02)
NCT04954794 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2024-10-31
Summary
The objective of this study is to evaluate the efficacy and safety of TACE combined with Sintilimab plus bevacizumab biosimilar in patients with advanced hepatocellular carcinoma as first-line therapy.
Conditions
Interventions
- DRUG
-
Sintilimab
Sintilimab will be administered at 200 mg i.v. every 3 weeks plus a bevacizumab biosimilar at 15 mg/kg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
- COMBINATION_PRODUCT
-
TACE
TACE is performed by using drug-eluting beads or using microspheres combined with Lipiodol-pirarubicin emulsion per Investigator's decision. TACE treatment starts at day 0. Sintilimab plus a bevacizumab biosimilar will be initiated on day 14 after TACE.
Sponsors & Collaborators
-
Fudan University
lead OTHER
Principal Investigators
-
Peng Wang, MD · Fudan University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-14
- Primary Completion
- 2024-04-29
- Completion
- 2024-04-29
Countries
- China
Study Locations
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