Informations générales (source: ClinicalTrials.gov)
Study of the Benefit of Lenvatinib Treatment in Waiting List of Liver Transplantation After TACE Failure in Patients With Hepatocellular Carcinoma (HCC)
Interventional
Phase 1/Phase 2
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juillet 2024
avril 2027
03 décembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:36:18 | Contacter | |||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital Paul Brousse | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hospital Claude Huriez - Lille - France | Contact (sur clinicalTrials) | ||||
| Hospital Haut levêque - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Hospital Henri Mondor - Créteil - France | Contact (sur clinicalTrials) | ||||
| Hospital Trousseau - Tours - France | Contact (sur clinicalTrials) | ||||
| Pontchaillou Hospital - Rennes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Non resectable HCC
- Initial French AFP score < or = 2
- Registered on national waiting list for LT
- Who underwent TACE as a bridge to LT
- With no complete response after 2 TACE (i.e. persistent active disease, including
stable disease or partial response or progression)
- Non eligible for percutaneous ablation
- Informed, written consent obtained from the patient
- Having the rights to French social insurance
- Aged of 18 years or older
- Adequate bone marrow, liver and renal function as assessed by the following
laboratory tests:
- Hemoglobin > 8.5 g/dL
- Absolute neutrophil count ≥ 1500/mm3 (≥ 1200/mm3 for black/African, American)
- Platelet count ≥ 60,000/ mm3
- Total bilirubin ≤ 2 mg/dL or 34 mcmol/l
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x upper
limit of normal (ULN)
- Serum creatinine ≤ 1.5 x ULN
- Prothrombine time-international normalized ratio (PT-INR) < 2.3 and PTT < 50 %
- Glomerular Filtration Rate (GFR) ≥ 30 mL/min/1.73 m2
- Patient with QT/QTc < 480 ms
- Women of childbearing potential (WOCBP) need to accept one effective method of
contraception until 1 month after the last lenvatinib intake and avoid pregnancy
- Patients who are sexually active with WOCBP partners need to accept one effective
method of contraception until 1 month after lenvatinib intake and men must agree to
use adequate contraception.
- Non resectable HCC
- Initial French AFP score < or = 2
- Registered on national waiting list for LT
- Who underwent TACE as a bridge to LT
- With no complete response after 2 TACE (i.e. persistent active disease, including
stable disease or partial response or progression)
- Non eligible for percutaneous ablation
- Informed, written consent obtained from the patient
- Having the rights to French social insurance
- Aged of 18 years or older
- Adequate bone marrow, liver and renal function as assessed by the following
laboratory tests:
- Hemoglobin > 8.5 g/dL
- Absolute neutrophil count ≥ 1500/mm3 (≥ 1200/mm3 for black/African, American)
- Platelet count ≥ 60,000/ mm3
- Total bilirubin ≤ 2 mg/dL or 34 mcmol/l
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x upper
limit of normal (ULN)
- Serum creatinine ≤ 1.5 x ULN
- Prothrombine time-international normalized ratio (PT-INR) < 2.3 and PTT < 50 %
- Glomerular Filtration Rate (GFR) ≥ 30 mL/min/1.73 m2
- Patient with QT/QTc < 480 ms
- Women of childbearing potential (WOCBP) need to accept one effective method of
contraception until 1 month after the last lenvatinib intake and avoid pregnancy
- Patients who are sexually active with WOCBP partners need to accept one effective
method of contraception until 1 month after lenvatinib intake and men must agree to
use adequate contraception.
- Contraindication of lenvatinib and excipient
1. Cardiovascular:
- Rhythmic or ischemic recent or uncontrolled cardiac disease: Pacemakers or
patients who have a history of cardiac arrhythmias or irregular heartbeats
(in case of electroporation procedure)
- Congestive heart failure New York Heart Association (NYHA) ≥ class 2
- Unstable angina or myocardial infarction within the past 6 months before
enrolment
- Uncontrolled arterial hypertension (systolic ≥ 140 mmHg, diastolic ≥ 90
mmHg)
2. Ongoing ascites: Refractory ascites according to EASL guidelines definition
(ascites that cannot be mobilized or the early recurrence of which cannot be
prevented because of a lack of response to sodium restriction and diuretic
treatment)
3. Coagulopathy
4. Ongoing infection > Grade 2 according to NCI-current CTCAE . Hepatitis B is
allowed if no active replication is present (below 100 IU/mL). Hepatitis C is
allowed if no antiviral treatment is ongoing
- Known hypersensitivity to the study drug or excipients in the formulation
- Decompensated cirrhosis (Child-Pugh > A6)
- Prior systemic therapy with oral TKI and/or immunotherapy
- Past or concurrent history of neoplasm other than HCC, except for in situ carcinoma
of the cervix uteri and/or non-melanoma skin cancer and superficial bladder tumours.
Any cancer curatively treated > 3 years prior to study entry is permitted
- Recent digestive bleeding associated with portal hypertension (whithin the 3 months
prior to inclusion in the study)
- Advanced or Metastatic HCC (BCLC C)
- Persistent proteinuria of NCI-current CTCAE ≥ Grade ≥ Grade 3
- Project of living donor
- Pregnant or lactating woman
- Curator or guardianship or patient placed under judicial protection
- Participation in other interventional research during the study.
- History within the past 3 months before enrollment of haemorrhage, gastrointestinal
perforation, gastrointestinal or non-gastrointestinal fistula,
- History of aneurism,
- Hypokalemia, hypomagnesemia and hypocalcemia