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Clinical Trials in France / NCT05901194
Active, not recruiting Phase 1/2

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

NCT05901194 · tracked via the Priya Life Science France tracker
Phase
Phase 1/2
Started
2024-07-10
Last updated
2025-04-07

Condition(s) studied

Hepatocellular Carcinoma Non-resectable

Investigational drug(s) / intervention(s)

Lenvatinib →

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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. Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
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

On this site

📄 Lenvima (lenvatinib) drug profile →

More Assistance Publique - Hôpitaux de Paris trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05901194 on ClinicalTrials.gov ↗ ← All trials in France