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Hepatocellular Carcinoma Non-resectablePhase 1/2Ta-Len-TraNCT05901194

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

A Phase 1/2 study testing Lenvatinib in people with Hepatocellular Carcinoma Non-resectable, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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%). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma Non-resectable
What is being tested?
Lenvatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
6 sitesFrance
Study dates
10 Jul 2024to Apr 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • Contraindication of lenvatinib and excipient
  • 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)
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  • 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)
  • Coagulopathy
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Hospital Haut levêque

    Bordeaux

  • Hospital Henri Mondor

    Créteil

  • Hospital Claude Huriez

    Lille

  • Pontchaillou Hospital

    Rennes

  • Hospital Trousseau

    Tours

  • Paul Brousse Hospital

    Villejuif

Other trials in France

About this study

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

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.

Read the detailed description

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.

Being tested
Lenvatinib
Keywords
Liver transplantation, non resectable hepatocellular carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenvatinibDrug

    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 groups in NCT05901194
Study groupRoleWhat they receive
LenvatinibExperimentalLenvatinib 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
Receives: Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

Secondary outcomes (6)

  1. Time to progression under lenvatinib

    Time to progression under lenvatinib before LT by imaging. Progression will be based on RECIST and mRECIST

    Measured: up to 12 months and until LT

  2. Progression under lenvatinib

    Progression under lenvatinib before LT by imaging. Progression will be bases on RECIST and mRECIST

    Measured: up to 12 months and until LT

  3. Response rate

    Response rate before LT by imaging

    Measured: up to 12 months and until LT

  4. Response rate

    Response rate by liver specimen pathology after the LT

    Measured: after the LT, during 18 months

  5. Recurrence rate

    Recurrence rate after LT by imaging

    Measured: after LT, during 18 months

  6. Incidence of Treatment-Emergent Adverse Events

    Incidence of Treatment-Emergent Adverse Events using current CTCAE

    Measured: Throughout the study, an average of 31 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2023
  2. Study start10 Jul 2024
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05901194
Sponsor's protocol ID
APHP220267
Other IDs
2022-000998-31
Acronym
Ta-Len-Tra
Status last verified
Mar 2025
First submitted
26 May 2023
Last updated
7 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenvatinib in people with Hepatocellular Carcinoma Non-resectable, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of patients with lenvatinib who have a Liver transplantation (LT) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05901194.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2025.

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