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Study on Liver Cancer in Cirrhosis Patients Using Idarubicin and Lipiodol Injection

Verified siteRegistered drugNo placebo
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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, which often occurs in people with liver cirrhosis. The treatment being tested involves a combination of two substances: Idarubicin and Lipiodol. Idarubicin is a chemotherapy drug, while Lipiodol is a special oily substance that helps deliver the chemotherapy directly to the liver. The purpose of the study is to evaluate how well this treatment controls the disease four months after the first treatment cycle.

Participants in the study will receive the treatment through an injection directly into the liver's blood supply. This method is intended to target the cancer more effectively. The study will last for about 12 months, during which the participants will be monitored regularly to assess the response to the treatment and any side effects. The study aims to see if the cancer can be controlled, meaning it either shrinks, disappears, or remains stable without growing.

Throughout the study, various aspects will be evaluated, such as the time it takes for the treatment to stop working, the length of time participants live without the cancer getting worse, and overall survival. The study will also look at the quality of life of participants and any potential side effects, such as issues with blood vessels in the liver. This information will help determine the effectiveness and safety of the Idarubicin and Lipiodol treatment for people with Hepatocellular Carcinoma.

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

    Joining the study

    Upon joining the study, the patient must provide written informed consent. This confirms understanding and agreement to participate in the trial.

    Eligibility is confirmed based on specific criteria, including age, health status, and previous treatments.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the patient's health status and ensure all eligibility criteria are met.

    This includes checking heart function, blood counts, and liver function.

  3. Step 3

    Treatment administration

    The treatment involves the administration of an emulsion containing idarubicin hydrochloride and ethyl esters of iodised fatty acids from poppyseed oil.

    This is delivered through an intravenous perfusion, which means the medication is given directly into a vein.

    The specific product names used are ZAVEDOS 10 mg and LIPIODOL ULTRA FLUIDE 480 mg/ml.

  4. Step 4

    Monitoring and follow-up

    The patient's response to the treatment is monitored using mRECIST criteria, which helps assess the size and number of tumors.

    Regular follow-up appointments are scheduled to evaluate the disease control rate at 4 months after the first treatment cycle.

  5. Step 5

    Evaluation of treatment outcomes

    Primary outcomes include assessing the disease control rate, which can be partial, complete, or stable response.

    Secondary outcomes involve measuring progression-free survival, overall survival, and quality of life over a period of up to 12 months.

  6. Step 6

    Completion of the trial

    The trial is estimated to conclude by January 18, 2026.

    Final assessments will be conducted to determine the overall effectiveness and safety of the treatment.

Who can join the trial?

15 criteria

  • The patient must have **Hepato carcinoma cancer**, which is a type of liver cancer.
  • The cancer must be confirmed by a test called **histology** or meet specific criteria set by the **European Association for the Study of the Liver (EASL)**.
  • The patient should not have **heart failure**, and a heart test called **Ultrasound LVEF** should show a result greater than 50%.
  • Women who can have children must use a reliable method of birth control during the treatment and for 6.5 months after the treatment ends.
  • Men must use a reliable method of birth control during the treatment and for at least 3.5 months after the treatment ends.
  • The patient must agree to participate by signing a **written informed consent** form.
  • The patient must have **national health insurance** coverage in France.
  • The patient's liver function should be classified as **Child-Pugh A or B7**, which are categories used to assess liver health.
  • The disease should not be treatable by surgery, **ablation** (removal of tissue), or **radiofrequency** (a type of heat treatment).
  • The patient should have a **Performance Status ECOG** of 0 or 1, which indicates how well they can perform daily activities.
  • If the patient has a **BCLC** stage A/B or C, their Performance Status ECOG should be 1. **BCLC** is a system to classify liver cancer stages.
  • The patient must have **measurable lesions** according to specific criteria called **mRECIST**.
  • The patient should not have had previous treatments like chemotherapy, radiotherapy, or certain types of embolization or radioembolisation.
  • The patient must be 18 years old or older.
  • The patient must have certain blood test results: **Platelets** greater than 50,000/mm3, **Polynuclear neutrophils** greater than 1000/mm3, **Creatininemia** less than 150 umol/L, and **Bilirubinemia** less than 5 mg/dL.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer than hepato carcinoma cancer cannot participate. Hepato carcinoma is a type of liver cancer.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.
  • Patients who do not meet the specific health criteria set by the study cannot participate. These criteria are usually based on the patient's overall health and medical history.
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Investigated drugs

  • Idarubicin

    is a medication used in this trial to treat liver cancer. It is a type of chemotherapy drug that helps to kill cancer cells or stop them from growing. In this study, it is administered directly into the liver through an artery to target the cancer more effectively.

  • Lipiodol

    is an oily substance used in this trial to help deliver the chemotherapy drug, idarubicin, directly to the liver tumor. It acts as a carrier, allowing the medication to stay in the liver longer and improve its effectiveness against the cancer cells.

What is already known about the treatment

Idarubicin – Idarubicin is administered as an injection directly into the liver's artery, often mixed with Lipiodol, a contrast agent. It is currently being studied in clinical trials for its effectiveness in treating liver cancer, specifically hepatocellular carcinoma. The main therapeutic indication is to control the progression of liver cancer in patients with cirrhosis. At the molecular level, Idarubicin works by intercalating into DNA, disrupting the replication process, and inhibiting the enzyme topoisomerase II, which is essential for DNA repair. It is classified as an anthracycline antibiotic, a type of chemotherapy drug.

Investigated diseases

Hepatocellular Carcinoma – This is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It often develops in the context of chronic liver disease, such as cirrhosis or hepatitis. The disease may initially present with symptoms like abdominal pain, weight loss, or jaundice. As it progresses, the tumor can grow and spread to other parts of the liver or beyond. The progression can lead to complications such as liver failure or metastasis to other organs. The disease's course can vary significantly depending on the underlying liver condition and the extent of the cancer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515456-20-00Protocol codeLIDA-BIIEstimated enrolment53 patientsSponsorCentre Hospitalier Universitaire De Montpellier

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