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.
The investigators identified a sub-group of patients with non resectable HCC that could benefit from a systemic neoadjuvant medical strategy before liver transplantation (LT). In these patients, the investigators propose to add oral systemic chemotherapy with lenvatinib as a bridging/downstaging therapeutic approach until LT. In the case of at least partial response or stability under lenvatinib and within AFP score of 2, the patients will be transplanted and lenvatinib will be stopped on the day or the day before LT (depending on the availability of the graft). In the case of disease progression, the patient will stop prematurely the lenvatinib treatment and will be treated according to usual practices. The patient's eligibility for LT will be assessed according to usual practices.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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
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
The proportion of patients with lenvatinib who have a Liver transplantation (LT)
The proportion of patients with TACE failure and treated with lenvatinib who have a LT
Time frame: 12 months
Time to progression under lenvatinib
Time to progression under lenvatinib before LT by imaging. Progression will be based on RECIST and mRECIST
Time frame: up to 12 months and until LT
Progression under lenvatinib
Progression under lenvatinib before LT by imaging. Progression will be bases on RECIST and mRECIST
Time frame: up to 12 months and until LT
Response rate
Response rate before LT by imaging
Time frame: up to 12 months and until LT
Response rate
Response rate by liver specimen pathology after the LT
Time frame: after the LT, during 18 months
Recurrence rate
Recurrence rate after LT by imaging
Time frame: after LT, during 18 months
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events using current CTCAE
Time frame: Throughout the study, an average of 31 months
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