NCT04319484

Lenvatinib Following Liver Transplantation in Patients of Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

A Randomized Controlled Study of Lenvatinib Following Liver Transplantation in Patients of Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The research is an open, randomized, single-center study. Patients of hepatocellular carcinoma with portal vein cancer thrombus who underwent liver transplantation are included according to the criteria of admission. After operation, the regimen of calcineurin inhibitors, mycophenolate mofetil, sirolimus or everolimus with glucocorticoids removed at an early stage are used. Patients enrolled in the study were randomly allocated in the lenvatinib group (54 patients) and the control group (54 patients) after stable condition. Patients in the control group are given supportive treatment and regular follow-up. Patients in the lenvatinib group are given lenvatinib within 1-2 months after operation (dose: body weight \< 60 kg: 8 mg/day, body weight ≥ 60 kg 12 mg/day). The baseline data of patients are collected before allocation. Serum and imaging examination are checked regularly every month to monitor the recurrence of hepatocellular carcinoma and the side effects of lenvatinib. The efficacy and safety of lenvatinib in patients of hepatocellular carcinoma with portal vein tumor thrombus are observed, and the clinicopathological factors affecting the efficacy of lenvatinib are analyzed. When side effects of lenvatinib occur, the dosage can be reduced according to the patients' condition until discontinuation. When tumor recurrence occurs, a multidisciplinary team will draw up specific treatment plans according to the patients' condition, including surgical resection, interventional therapy, radiofrequency therapy, radiotherapy and targeted therapy (Patients in the control group can add lenvatinib, and patients in the lenvatinib group can decide whether to continue using it according to the patients' condition).

Conditions

• Hepatocellular Carcinoma
• Portal Vein Tumor Thrombus
• Liver Transplantation

Interventions

Type	Name	Description
DRUG	lenvatinib	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	Placebo	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.

Timeline

• Start date: 2020-05-02
• Primary completion: 2025-01-01
• Completion: 2025-12-01
• First posted: 2020-03-24
• Last updated: 2020-03-24

Regulatory

• FDA-regulated drug study