Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of lenvatinib treatment benefits in patients with non-resectable liver cancer (hepatocellular carcinoma) who are on liver transplant waiting list after unsuccessful TACE therapy

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with hepatocellular carcinoma (HCC), a type of liver cancer that cannot be surgically removed. The research examines the effectiveness of lenvatinib, a medication taken as hard capsules by mouth, in patients who are waiting for a liver transplantation and whose previous treatment with TACE (a procedure that delivers chemotherapy directly to liver tumors) was not completely successful.

The purpose of this research is to determine how many patients who take lenvatinib can successfully proceed to liver transplantation after their previous TACE treatment did not provide complete tumor control. The medication is designed to help control the cancer while patients are waiting for their transplant surgery.

During the study, participants will receive lenvatinib treatment and undergo regular medical evaluations to monitor their response to the medication. The research team will track how the tumors respond to the treatment and assess the safety of using lenvatinib in patients awaiting liver transplantation. They will also monitor patients after their transplant surgery to evaluate the long-term outcomes of this treatment approach.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your eligibility for the trial will be confirmed through laboratory tests checking your bone marrow, liver, and kidney function

    A heart test will be performed to check your QT/QTc interval which must be less than 480 ms

    Your AFP score (a type of liver cancer marker) will be verified to be 2 or lower

  2. Step 2

    Treatment initiation

    You will receive Lenvima (lenvatinib) in the form of 4 mg hard capsules

    The medication will be taken by mouth

    You must already be registered on the national waiting list for liver transplantation

    You must have previously undergone two unsuccessful TACE procedures (a type of liver cancer treatment)

  3. Step 3

    Monitoring period

    Regular imaging tests will be conducted to monitor your response to the treatment

    Your condition will be evaluated using specific measurement criteria called RECIST and mRECIST

    Blood tests will be performed to monitor your health status

    Any side effects will be recorded and monitored

  4. Step 4

    Liver transplantation phase

    When a suitable liver becomes available, you will undergo transplantation surgery

    The removed liver tissue will be examined to evaluate your response to the treatment

    After transplantation, you will be monitored for any signs of cancer recurrence through imaging tests

  5. Step 5

    Follow-up period

    Regular check-ups will continue to monitor your recovery after transplantation

    Imaging tests will be performed to check for any signs of cancer returning

    The study will continue until August 2028

Who can join the trial?

12 criteria

  • Must be at least 18 years old
  • Must have non-resectable liver cancer (HCC) that cannot be removed surgically
  • Must have adequate blood test results showing: - Hemoglobin above 8.5 g/dL - White blood cell count above 1500/mm3 (or 1200/mm3 for Black/African American patients) - Platelet count above 60,000/mm3 - Liver and kidney function tests within specified limits
  • Must have a heart rhythm measurement (QT/QTc) less than 480 milliseconds
  • Women who can become pregnant must agree to use effective birth control for 1 month after completing treatment
  • Men with partners who can become pregnant must use effective birth control for 1 month after completing treatment
  • Must have an initial AFP score (a blood test that measures liver cancer markers) of 2 or less
  • Must be registered on the national liver transplant waiting list
  • Must have previously received TACE treatment (a procedure to block blood supply to liver tumors) but did not achieve complete response after 2 treatments
  • Must not be eligible for percutaneous ablation (a procedure using heat to destroy tumors through the skin)
  • Must provide written informed consent
  • Must have French social insurance coverage

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Previous or current treatment with lenvatinib (a targeted cancer medication)
  • Complete response to TACE (Transarterial chemoembolization - a procedure that blocks blood supply to liver tumors)
  • Presence of cancer that has spread outside the liver
  • Severe liver dysfunction or cirrhosis (extensive scarring of the liver)
  • Pregnancy or breastfeeding
  • Active or uncontrolled serious infections
  • Uncontrolled high blood pressure
  • History of other cancers in the past 5 years
  • Significant heart problems or recent heart attack
  • Severe bleeding disorders
  • Major surgery within the last 4 weeks
  • Current participation in other clinical trials
  • Mental conditions that prevent understanding of study requirements
  • Known allergies to study medications
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Lenvatinib is an oral medication used to treat liver cancer (hepatocellular carcinoma). It works by blocking certain proteins that help cancer cells grow and spread. This medication is used when other treatments, like TACE (Trans-Arterial Chemoembolization), haven't been completely successful. It can help control tumor growth in patients who are waiting for a liver transplant. TACE (Trans-Arterial Chemoembolization) is a medical procedure where doctors inject chemotherapy medication directly into the blood vessels that feed the liver tumor, followed by materials that block these blood vessels. This treatment aims to shrink the tumor by cutting off its blood supply while delivering chemotherapy directly to the cancer cells.

What is already known about the treatment

Lenvatinib - An oral targeted therapy medication used primarily in the treatment of non-resectable hepatocellular carcinoma (liver cancer) when other treatments like TACE (transarterial chemoembolization) have not been successful. This medication works by blocking specific proteins called kinases that are involved in the growth and spread of cancer cells, particularly those that help form new blood vessels that feed tumors. Lenvatinib belongs to the class of drugs known as tyrosine kinase inhibitors (TKIs) and is administered in capsule form, taken once daily. The medication has shown significant effectiveness in patients awaiting liver transplantation and is currently approved by major medical authorities worldwide for treating various types of advanced cancers.

Investigated diseases

Hepatocellular Carcinoma (HCC) - A primary liver cancer that begins in the main type of liver cells (hepatocytes). The disease typically develops in people with chronic liver diseases, such as cirrhosis. HCC usually starts as several small cancer nodules throughout the liver, rather than a single large tumor. As the disease progresses, these nodules can grow larger and spread to other parts of the liver. The condition affects liver function and can cause the organ to work less efficiently over time. Non-resectable HCC refers to tumors that cannot be completely removed through surgery due to their size, location, or number.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516408-40-00Protocol codeAPHP220267Estimated enrolment25 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.