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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Cafrds Hpxmadznurs Rdcxzptt Dohmeadmxijsjv	Angers	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	19.07.2018

Trial locations

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.

Investigated diseases:

Hepatocellular carcinoma

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 ID:

2024-515456-20-00

Protocol code:

LIDA-BII

NCT ID:

NCT03727633

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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