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Study of Atezolizumab and Bevacizumab for Patients with High-Risk Hepatocellular Carcinoma After Surgery or Ablation

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 (HCC), particularly in patients who are at high risk of the cancer returning after they have had surgery or a procedure called ablation to remove the cancer. The study is testing a combination of two medications, atezolizumab and bevacizumab, to see if they can help prevent the cancer from coming back. Atezolizumab is also known by its code name, RO5541267, and is an antibody that helps the immune system fight cancer. Bevacizumab is another antibody that works by stopping the growth of blood vessels that feed tumors.

The purpose of the study is to compare the effectiveness of the combination of atezolizumab and bevacizumab with a group of patients who will be under active surveillance, meaning they will be closely monitored without receiving the study medications. The study will last for up to 12 months, during which participants will receive the medications through an intravenous (IV) infusion, which means the medicine is given directly into a vein. The study will track how long patients remain free from cancer recurrence and will also monitor overall survival rates and any side effects experienced by participants.

Participants in the study will have regular check-ups and tests to monitor their health and the status of their cancer. The study aims to provide valuable information on whether the combination of atezolizumab and bevacizumab can be an effective treatment option for preventing the return of hepatocellular carcinoma in patients who have already undergone surgery or ablation. This research could potentially lead to new treatment strategies for managing 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

    Joining the study

    Participation begins after a diagnosis of hepatocellular carcinoma (HCC) and undergoing either surgical removal or a procedure to destroy the tumor.

    Eligibility requires a high risk of cancer returning and full recovery from surgery or procedure within four weeks before starting the study.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving medication and the other under observation without medication.

  3. Step 3

    Medication administration

    For those in the medication group, treatment involves two drugs: atezolizumab and bevacizumab.

    Atezolizumab is given as an intravenous infusion, which means it is administered directly into a vein. The dosage is 1,200 mg.

    Bevacizumab is also given as an intravenous infusion, with a concentration of 25 mg/ml.

  4. Step 4

    Treatment duration

    The treatment continues for a specified period, with regular monitoring to assess the response and any side effects.

  5. Step 5

    Monitoring and follow-up

    Participants are regularly monitored for cancer recurrence and overall health status.

    Assessments include checking vital signs, laboratory tests, and the presence of any antibodies against the medication.

  6. Step 6

    Study completion

    The study is expected to conclude by July 16, 2027, with ongoing evaluations of survival rates and recurrence-free survival.

Who can join the trial?

8 criteria

  • Participants must have a first diagnosis of high-risk hepatocellular carcinoma (HCC), which is a type of liver cancer.
  • Participants should have undergone either curative resection (surgical removal of the cancer) or ablation (a procedure to destroy cancer cells) within 4-12 weeks before joining the study.
  • Participants must be at high risk for HCC coming back after resection or ablation.
  • Participants need to have fully recovered from the surgical resection or ablation within 4 weeks before joining the study.
  • Participants should not have MVI (Vp3 or Vp4), which means there should be no major blood vessel invasion by the cancer.
  • Participants must have an ECOG Performance Status of 0 or 1, which indicates they are fully active or have some symptoms but can still carry out light work.
  • Participants should have a Child-Pugh Class A status, which means their liver function is still good.
  • Participants can be of any gender.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer that are not **high-risk hepatocellular carcinoma (HCC)** cannot participate. **Hepatocellular carcinoma** is a type of liver cancer.
  • Patients who have had previous treatments that might interfere with the study results are not eligible.
  • Patients with serious health conditions that could make participation unsafe are excluded.
  • Patients who are unable to follow the study procedures or attend required visits cannot join the study.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients who have participated in another clinical trial recently may be excluded.
  • Patients with allergies to the study medications or similar drugs cannot take part.
  • Patients with certain infections or diseases that could affect the study outcomes are not eligible.
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Investigated drugs

  • Atezolizumab

    is a type of medication known as an anti-PD-L1 antibody. It works by helping the immune system recognize and attack cancer cells. In this trial, it is being used to see if it can help prevent the return of liver cancer after surgery or other treatments.

  • Bevacizumab

    is a medication that targets and inhibits a protein called VEGF, which is involved in the growth of blood vessels that supply tumors. By blocking this protein, bevacizumab can help slow or stop the growth of cancer by cutting off its blood supply. In this trial, it is used in combination with atezolizumab to see if it can improve outcomes for patients with liver cancer.

What is already known about the treatment

  • Atezolizumab

    Atezolizumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating high-risk hepatocellular carcinoma (HCC) after surgical resection or ablation. It is an anti-PD-L1 antibody that works by blocking the interaction between PD-L1 and its receptors, thereby enhancing the immune system's ability to attack cancer cells. Atezolizumab is classified as an immune checkpoint inhibitor and is being evaluated for its potential to improve recurrence-free survival in patients.

  • Bevacizumab

    Bevacizumab is also administered intravenously and is being tested in combination with atezolizumab for high-risk hepatocellular carcinoma (HCC) in clinical trials. It is a monoclonal antibody that inhibits vascular endothelial growth factor (VEGF), which plays a crucial role in the formation of blood vessels that supply tumors. By blocking VEGF, bevacizumab aims to reduce tumor blood supply, thereby inhibiting tumor growth. It is classified as an angiogenesis inhibitor and is being assessed for its effectiveness in preventing cancer recurrence.

Investigated diseases

Hepatocellular Carcinoma – Hepatocellular carcinoma (HCC) is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It is often associated with chronic liver diseases such as hepatitis B or C infections and cirrhosis. The disease typically progresses through stages, starting with localized tumors that can grow and spread within the liver. As it advances, HCC may metastasize to other parts of the body, including the lungs and bones. Symptoms may include abdominal pain, weight loss, and jaundice, but they often appear only in later stages. Early detection is challenging, making regular monitoring crucial for those at high risk.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504303-86-00Protocol codeWO41535Estimated enrolment668 patientsSponsorF. Hoffmann-La Roche AG

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