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Study on Adding Ipilimumab to Atezolizumab and Bevacizumab for Patients with Liver Cancer Receiving First-Line Treatment

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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. The study is exploring the effects of adding a medication called Ipilimumab to a combination of two other medications, Atezolizumab and Bevacizumab. These medications are given as solutions through a vein, a method known as intravenous infusion. The purpose of the study is to evaluate whether this combination of treatments can improve outcomes for patients receiving their first systemic therapy for this type of cancer.

Participants in the study will be divided into two groups. One group will receive the combination of Atezolizumab and Bevacizumab, while the other group will receive all three medications, including Ipilimumab. The study will last for a period of up to 24 months, during which the effects of the treatments will be monitored. The main goal is to see if the addition of Ipilimumab can help improve the overall survival of patients compared to the two-drug combination. The study will also look at how well the cancer responds to the treatments and how long patients can live without the disease getting worse.

Throughout the study, participants will receive regular check-ups to monitor their health and the progress of their cancer. The study aims to provide valuable information on whether the addition of Ipilimumab offers a significant benefit in treating hepatocellular carcinoma. Participants will be closely observed for any side effects or changes in their quality of life during the treatment period. This research could potentially lead to improved treatment options for patients with this type of liver cancer.

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

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the treatments being tested.

  2. Step 2

    Treatment administration

    You will receive medications through an intravenous infusion, which means the medicine will be given directly into your vein. The medications used in this study are ipilimumab, bevacizumab, and atezolizumab.

    The specific combination and dosage of these medications will depend on the group you are assigned to. The treatment will be administered in cycles, with each cycle lasting a few weeks.

  3. Step 3

    Monitoring and assessments

    Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and imaging tests to assess how the treatment is affecting your condition.

    The main goal during the first 24 weeks (9 cycles) is to evaluate the response to the treatment, which could be a complete response, partial response, or no change.

  4. Step 4

    Continuation and follow-up

    If the treatment is effective and you are tolerating it well, you may continue to receive it as part of the study. Your overall survival and quality of life will be assessed over time.

    The study aims to compare the effectiveness of the treatment combinations in terms of overall survival and other health outcomes.

  5. Step 5

    End of participation

    Your participation in the study will conclude either when the study ends or if you choose to withdraw. You will be informed about the results of the study and any potential implications for your future treatment.

Who can join the trial?

15 criteria

  • Must be at least 18 years old.
  • Women who can have children must agree to use birth control during the trial and for at least 6 months after stopping the trial treatments. Men who have sex with women who can have children must also agree to use birth control during the trial and for at least 6 months after stopping the trial treatments.
  • Must be able to understand, sign, and date the informed consent form before being randomly assigned to a treatment group.
  • Must be part of a social security scheme.
  • Must have a confirmed diagnosis of hepatocellular carcinoma (HCC) through a biopsy done less than two years ago. If not confirmed, a liver biopsy is required.
  • Must have a WHO performance status of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
  • HCC must not be treatable by surgery, heat treatment, liver transplant, or certain palliative treatments for intermediate stage HCC.
  • Must have advanced or intermediate HCC after failure or inability to use a specific treatment called CEL.
  • Must have normal levels of Troponin-T, a protein that helps diagnose heart problems.
  • Must not have visible fluid buildup in the abdomen (ascites) or a history of liver failure-related brain issues (encephalopathy).
  • Must have adequate liver function, with specific blood test results: AST and ALT levels no more than 5 times the upper normal limit, total bilirubin no more than 35 micromoles per liter, albumin at least 28 grams per liter, and a Child-Pugh A score if cirrhosis is present.
  • Must have adequate blood and kidney function, with specific test results: hemoglobin more than 8.5 grams per deciliter, platelets more than 60 billion per liter, neutrophils more than 1.5 billion per liter, and creatinine clearance at least 40 milliliters per minute.
  • Must have controlled heart disease for at least 6 months.
  • Must have at least one measurable tumor according to specific criteria (RECIST v1.1).
  • Must have had an esophageal endoscopy within the last 6 months. If varicose veins are found, they should be treated with beta-blockers unless there are reasons not to use them.

Who cannot join the trial?

11 criteria

  • Patients who have a different type of cancer other than hepatocellular carcinoma cannot participate.
  • Patients who have had another cancer treatment within the last 4 weeks are not eligible.
  • Patients with severe heart problems, such as heart failure or a recent heart attack, cannot join the study.
  • Patients with uncontrolled high blood pressure are not allowed to participate.
  • Patients with active infections, including HIV or hepatitis, are excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the trial.
  • Patients with a history of severe allergic reactions to similar medications are not eligible.
  • Patients with significant liver disease, other than hepatocellular carcinoma, are excluded.
  • Patients who have had a major surgery within the last 4 weeks cannot participate.
  • Patients with a history of drug or alcohol abuse within the last 6 months are not eligible.
  • Patients who are unable to follow the study procedures or attend scheduled visits are excluded.
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Investigated drugs

  • Ipilimumab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, Ipilimumab is being tested to see if it can improve the treatment of liver cancer when added to other medications.

  • Atezolizumab

    is another immune checkpoint inhibitor. It helps your immune system fight cancer by blocking a protein that prevents your immune cells from attacking cancer cells. This medication is already used in treating some types of cancer, and the trial is exploring its effectiveness in liver cancer.

  • Bevacizumab

    is a medication that works by blocking the growth of blood vessels that supply nutrients to tumors. By cutting off the blood supply, it can help slow down or stop the growth of cancer. In this trial, Bevacizumab is being used in combination with other medications to see if it can improve outcomes for patients with liver cancer.

What is already known about the treatment

  • Ipilimumab

    Ipilimumab is administered as an intravenous infusion, meaning it is given directly into a vein through a drip. It is currently being studied in clinical trials for its potential benefits in treating hepatocellular carcinoma, a type of liver cancer. The main therapeutic use of Ipilimumab is to help the immune system attack cancer cells more effectively. At the molecular level, it works by blocking a protein called CTLA-4, which normally helps keep the immune system in check, thereby boosting the body's immune response against cancer cells. Ipilimumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.

  • Atezolizumab

    Atezolizumab is given as an intravenous infusion, which involves delivering the medication directly into the bloodstream through a vein. It is being explored in clinical trials for its effectiveness in treating hepatocellular carcinoma, a form of liver cancer. The primary therapeutic role of Atezolizumab is to enhance the immune system's ability to fight cancer. It achieves this by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. Atezolizumab is part of a class of drugs known as immune checkpoint inhibitors, which are a type of cancer immunotherapy.

  • Bevacizumab

    Bevacizumab is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently under investigation in clinical trials for its potential to treat hepatocellular carcinoma, a type of liver cancer. The main therapeutic purpose of Bevacizumab is to inhibit the growth of blood vessels that supply nutrients to tumors, effectively starving the cancer cells. It works by blocking a protein called VEGF, which is responsible for the formation of new blood vessels. Bevacizumab is classified as an angiogenesis inhibitor, a type of targeted cancer therapy.

Investigated diseases

Hepatocellular carcinoma – Hepatocellular carcinoma is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It typically begins as a single tumor that grows larger over time, but it can also start as multiple small cancer nodules throughout the liver. As the disease progresses, it can invade nearby blood vessels and spread to other parts of the body, such as the lungs and bones. The progression of hepatocellular carcinoma is often associated with underlying liver conditions, such as cirrhosis or chronic hepatitis infection. Symptoms may include abdominal pain, weight loss, and jaundice, which can worsen as the disease advances. The growth rate and pattern of spread can vary significantly among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2022-501217-31-00Protocol codePRODIGE81-TRIPLETEstimated enrolment574 patientsSponsorFondation Franc.Cancerologie Digestive

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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