drugset / Trial / NCT06409637

FOLFOX Plus Lenvatinib Adjuvant Therapy for Hepatocellular Carcinoma Post-Liver Transplantation

NCT06409637

Phase 1/2 Not yet recruiting 62 enrolled Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
NaSingle-groupOpen-labelPrevention

Summary

Liver transplantation not only removes the liver tumor (seed) but also eliminates the underlying diseased liver (soil), making it an essential therapeutic approach for hepatocellular carcinoma (HCC). However, the tumor recurrence post-liver transplantation significantly jeopardizing the long-term survival of transplant recipients. Given the scarcity of donor livers, exploring effective measures to prevent tumor recurrence after liver transplantation holds significant clinical and societal value. Currently, there is no consensus on adjuvant therapy for preventing tumor recurrence post-liver transplantation for HCC, and the quantity and quality of studies on systemic chemotherapy are limited. In recent years, administration of the FOLFOX regimen combined with lenvatinib has been widely used in the treatment of advanced HCC, showing remarkable efficacy. The aim of this study is to investigate the efficacy and safety of adjuvant chemotherapy with FOLFOX combined with lenvatinib in preventing tumor recurrence after liver transplantation for HCC beyond Milan criteria.

Timeline

Start
2025-01-01
Primary completion
2027-12-31
Completion
2029-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenvatinib Small molecule 8 mg
Subject Lenvatinib Small molecule 12 mg
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous