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Studies

Interventional Active not recruiting Phase 1/Phase 2

NCT05901194 on ClinicalTrials.gov

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

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

  • Sponsor: Assistance Publique - Hôpitaux de Paris
  • Collaborators: Laboratoire EISAI
  • Enrollment: 25 (Estimated)
  • Study start: 2024-07-10 (Actual)
  • Primary completion: 2027-04-01 (Estimated)
  • Study completion: 2027-04-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Hepatocellular Carcinoma Non-resectable

Intervention / Treatment

  • Drug: Lenvatinib

Primary Outcome Measures

  • The proportion of patients with lenvatinib who have a Liver transplantation (LT) (12 months)
    The proportion of patients with TACE failure and treated with lenvatinib who have a LT

Countries

France

Locations and Investigators

  • Assistance Publique Hopitaux De Paris, Creteil, France
    • Alain, LUCIANI
  • Centre Hospitalier Regional Universitaire De Tours, Chambray Les Tours, France
    • Marie, BESSON
  • Centre Hospitalier Universitaire De Lille, Lille Cedex, France
    • Géraldine, SERGENT
  • Centre Hospitalier Universitaire De Lille, Lille Cedex, France
  • Centre Hospitalier Universitaire De Bordeaux, Pessac, France
    • Panteleimon, PAPADOPOULOS
  • Centre Hospitalier Regional Universitaire De Tours, Chambray Les Tours, France
    • Ephrem, SALAME
  • Assistance Publique Hopitaux De Paris, Villejuif, France
    • Olivier, ROSMORDUC
  • Centre Hospitalier Universitaire De Rennes, Rennes, France
  • Assistance Publique Hopitaux De Paris, Villejuif, France
    • Maite, LEWIN
  • Centre Hospitalier Universitaire De Bordeaux, Pessac, France
  • Centre Hospitalier Universitaire De Bordeaux, Pessac, France
  • Centre Hospitalier Universitaire De Rennes, Rennes, France
    • Vanessa, BRUN
  • Centre Hospitalier Universitaire De Rennes, Rennes, France
    • Edouard, BARDOU JACQUET
  • Assistance Publique Hopitaux De Paris, Creteil, France
    • Christophe, DUVOUX

Study Officials