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ACTIVE NOT RECRUITING
NCT05901194
PHASE1/PHASE2

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: Study of the Benefit of Lenvatinib Treatment in Waiting List of Liver Transplantation After TACE Failure in Patients With Hepatocellular Carcinoma (HCC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2024-07-10

Completion Date

2027-04

Last Updated

2025-04-07

Healthy Volunteers

No

Interventions

DRUG

Lenvatinib

Lenvatinib will be administred orally and daily at the usual dose ( 8 or 12 mg per day depending on the weight \< or ≥ 60kg) in the 25 patients of the study from TACE failure until LT

Locations (6)

Hospital Haut levêque

Bordeaux, France

Hospital Henri Mondor

Créteil, France

Hospital Claude Huriez

Lille, France

Pontchaillou Hospital

Rennes, France

Hospital Trousseau

Tours, France

Paul Brousse Hospital

Villejuif, France