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Study of Lenvatinib for Patients with Poor-Prognosis Hepatocellular Carcinoma Undergoing Percutaneous Ablation Therapy

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What is this trial about?

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

This clinical trial is focused on studying a type of liver cancer known as Hepatocellular Carcinoma (HCC), specifically in patients with a poor prognosis at an early stage called BCLC A. The treatment being tested is a medication called Lenvatinib, which is provided in the form of 4 mg hard capsules. The study aims to evaluate the effectiveness of Lenvatinib when used before and after a procedure called percutaneous ablation, which is a minimally invasive treatment intended to destroy cancer cells in the liver.

The purpose of the study is to assess how well patients do without the cancer returning for one year after the ablation procedure. Participants will take Lenvatinib orally, and the study will monitor their progress over time. The trial will also look at how safe the medication is and how well patients respond to the treatment. The study will involve regular check-ups and imaging tests like CT scans or MRI to track the cancer's response to the treatment.

Throughout the study, researchers will collect samples and data to better understand how the treatment works and to identify any factors that might predict how well a patient responds to Lenvatinib. This information could help improve future treatments for Hepatocellular Carcinoma. The trial is designed to gather valuable insights into the potential benefits and safety of using Lenvatinib in combination with the ablation procedure for treating this type of liver cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initiation of treatment

    Upon joining the study, the patient begins treatment with lenvatinib, which is administered orally in the form of 4 mg hard capsules.

    The medication is taken daily, with the dosage and duration determined by the healthcare provider based on individual patient needs and response to treatment.

  2. Step 2

    Neo-adjuvant therapy phase

    During this phase, the patient continues to take lenvatinib as prescribed. The goal is to prepare the body for the upcoming procedure by potentially reducing the size of the tumor.

  3. Step 3

    Percutaneous ablation procedure

    The patient undergoes a percutaneous ablation (PA) procedure, which is a minimally invasive treatment aimed at destroying cancer cells in the liver.

    This procedure is performed with curative intent, meaning it aims to eliminate the cancerous tissue.

  4. Step 4

    Adjuvant therapy phase

    Following the PA procedure, the patient continues to take lenvatinib as part of the adjuvant therapy phase.

    This phase is intended to prevent the recurrence of cancer by targeting any remaining cancer cells.

  5. Step 5

    Follow-up and monitoring

    The patient is monitored regularly for one year after the PA procedure to assess local recurrence-free survival.

    Regular imaging tests, such as CT scans or MRIs, are conducted to evaluate the response to treatment and detect any signs of recurrence.

  6. Step 6

    Completion of trial participation

    At the end of the one-year follow-up period, the patient's participation in the trial is completed.

    The healthcare team evaluates the overall outcomes and provides further recommendations for ongoing care if necessary.

Who can join the trial?

16 criteria

  • Male or female patients who are at least 18 years old.
  • Must have good bone marrow, liver, and kidney function as shown by specific blood tests.
  • Must have a life expectancy of at least 3 months.
  • Women who can have children must agree to use one effective method of birth control until 1 month after the last dose of the study drug and avoid getting pregnant.
  • Men who are sexually active with women who can have children must agree to use one effective method of birth control until 1 month after the last dose of the study drug.
  • Must be part of a Social Security System.
  • Must sign a written informed consent form.
  • Must have a good nutritional status, with a Body Mass Index (BMI) greater than 18 kg/m² for those under 70 years old, or greater than 21 kg/m² for those over 70 years old.
  • Must have a confirmed diagnosis of **HCC** (Hepatocellular Carcinoma), which is a type of liver cancer, either new or recurring after previous treatment more than 6 months ago.
  • Must be at **Barcelona Clinical Liver Cancer (BCLC) stage Category A**, which is a classification for liver cancer.
  • Must have a single tumor larger than 3 cm but not more than 5 cm, or multiple tumors (up to 3) each not more than 3 cm, or a single tumor between 2 and 3 cm with specific characteristics like high **AFP** (Alpha-fetoprotein) levels, infiltrative form, or macro-trabecular subtype.
  • Must have **HCC** that can be treated with **PA** (Percutaneous Ablation), a procedure to destroy cancer cells, as determined by a team of specialists.
  • Must have at least one measurable lesion on a **CT** (Computed Tomography) scan or **MRI** (Magnetic Resonance Imaging) according to specific criteria for liver cancer.
  • Must not have any blockage in the portal vein, which is a major vein in the liver.
  • Must have a liver function status of **Child-Pugh Class A**, which indicates good liver function.
  • Must have an **ECOG Performance Status** of 0 or 1, which means the patient is fully active or has some symptoms but can carry out light work.

Who cannot join the trial?

5 criteria

  • Patients with a single tumor larger than 5 cm cannot participate.
  • Patients with more than three tumors, even if each is 3 cm or smaller, are not eligible.
  • Patients with a single tumor between 2 and 3 cm without specific characteristics like high levels of a protein called AFP (more than 100 ng/mL) cannot join.
  • Patients with a type of tumor growth called infiltrative form are excluded.
  • Patients with a specific tumor subtype known as macro-trabecular are not eligible.
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Investigated drugs

Lenvatinib is a medication used in this trial to treat patients with a specific type of liver cancer known as HepatoCellular Carcinoma. It is being tested as both a neo-adjuvant therapy, which means it is given before the main treatment to help shrink the tumor, and as an adjuvant therapy, which means it is given after the main treatment to help prevent the cancer from coming back. The goal of using Lenvatinib in this trial is to improve the chances of the cancer not returning after a procedure called percutaneous ablation, which is intended to cure the cancer.

What is already known about the treatment

Lenvatinib – Lenvatinib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating certain types of liver cancer, specifically Hepatocellular Carcinoma (HCC) in patients with poor prognosis. The main therapeutic indication for Lenvatinib is as a treatment for liver cancer, particularly when used in combination with other procedures like percutaneous ablation. At the molecular level, Lenvatinib works by inhibiting certain proteins that promote the growth of cancer cells, thereby slowing down or stopping the progression of the disease. It is classified as a tyrosine kinase inhibitor, which is a type of targeted cancer therapy.

Investigated diseases

Hepatocellular Carcinoma (HCC) – Hepatocellular carcinoma is a type of liver cancer that originates in the liver cells, known as hepatocytes. It often develops in the context of chronic liver disease, such as cirrhosis or hepatitis. The disease can present as a single large tumor or multiple small nodules within the liver. As it progresses, HCC may invade blood vessels and spread to other parts of the body. Symptoms can include abdominal pain, weight loss, and jaundice. The progression of the disease can vary, with some tumors growing slowly while others may advance more rapidly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514606-31-00Protocol codeAPHP201185Estimated enrolment50 patientsSponsorAssistance Publique Hopitaux De Paris

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