Lenvatinib Following Liver Transplantation in Patients of Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
NCT04319484 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 108
Last updated 2020-03-24
Summary
The aim of this study is to observe the efficacy and safety of lenvatinib in preventing recurrence of hepatocellular carcinoma patients with portal vein tumor thrombus after liver transplantation.
Conditions
- Hepatocellular Carcinoma
- Portal Vein Tumor Thrombus
- Liver Transplantation
Interventions
- DRUG
-
1-2 months after liver transplantation, participants are given lenvatinib with an initial dose of 8 mg (body weight \< 60 kg) or 12 mg orally once a day. The initial dose was 8 mg (body weight \< 60 kg) or 12 mg orally once a day.
- DRUG
-
1-2 months after liver transplantation, participants are given Placebo with an initial dose of 8 mg (body weight \< 60 kg) or 12 mg orally once a day. The initial dose was 8 mg (body weight \< 60 kg) or 12 mg orally once a day.
Sponsors & Collaborators
-
RenJi Hospital
lead OTHER
Principal Investigators
-
qiang xia, doctor · RenJi Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Year
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-02
- Primary Completion
- 2025-01-01
- Completion
- 2025-12-01
- FDA Drug
- Yes
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