drugset / Trial / NCT05901194

Lenvatinib Treatment in Waiting List of Liver Transplantation After TACE Failure in Patients With Hepatocellular Carcinoma

NCT05901194

Phase 1/2 Active not recruiting 25 enrolled Assistance Publique - Hôpitaux de Paris Laboratoire EISAI · collab
NaSingle-groupOpen-labelTreatment

Summary

Currently in France, hepatocellular carcinoma (HCC) represents over 30% of indications of liver transplantation (LT) (# 500 cases/year). Chemoembolization (TACE) is the most commonly used bridge treatment in those patients (estimate 60%). These patients will present with a complete response in only 60 % of the cases (# 180 patients per year in France) and failure in 40 % of the cases (# 120 patients per year in France). A systemic treatment using lenvatinib might provide a benefit in patients presenting with a non-resectable HCC in waiting list for LT and with a TACE failure (i.e. those with an active disease and a partial response or a stable disease or a progressive disease on imaging data, in particular when AFP remains significantly increased after 2 TACE) by decreasing dropout rate before LT and decreasing recurrence rate post-LT without new safety signal.

Timeline

Start
2024-07-10
Primary completion
2027-04
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral