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Study on Atezolizumab and Bevacizumab for Patients with Intermediate-Stage Liver Cancer

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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 intermediate-stage hepatocellular carcinoma. The trial is investigating the effectiveness and safety of a combination of two medications, atezolizumab and bevacizumab, compared to a procedure called transarterial chemoembolization, or TACE. Atezolizumab, also known by its code name RO5541267, and bevacizumab are both given as solutions for infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of this study is to determine how well the combination of these medications works in treating this stage of liver cancer and to compare it with the existing treatment method, TACE. Participants in the study will receive either the combination of atezolizumab and bevacizumab or undergo the TACE procedure. The study will monitor various aspects such as the time it takes for the treatment strategy to fail, overall survival rates, and the response of the cancer to the treatment. The study will also look at the safety of the treatments and how they affect the quality of life of the participants.

The trial is expected to run for several years, with an estimated end date in 2027. Participants will be closely monitored throughout the study to assess the effectiveness of the treatments and any potential side effects. The goal is to find a more effective treatment option for patients with this type of liver cancer, potentially improving their outcomes and quality of life.

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, the patient is required to provide a signed informed consent form. This document confirms the patient's understanding and agreement to participate in the trial.

    The patient must meet specific laboratory criteria, including acceptable levels of bilirubin and protein in urine, among others, to ensure eligibility for the trial.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm the diagnosis of intermediate-stage hepatocellular carcinoma. This may involve imaging tests such as CT or MRI scans.

    The patient's medical history is reviewed to ensure there are no severe comorbidities or untreated conditions that could interfere with the trial.

  3. Step 3

    Treatment administration

    The patient receives treatment with atezolizumab and bevacizumab, both administered as solutions for infusion through an intravenous route.

    The specific dosage and frequency of administration are determined by the trial protocol and the patient's individual health status.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the patient's response to treatment and to identify any potential side effects.

    Follow-up visits are scheduled to evaluate the patient's overall health, liver function, and progression of the disease.

  5. Step 5

    End of treatment

    The treatment phase concludes based on the trial's duration or if the patient experiences significant changes in health status.

    Final assessments are performed to determine the effectiveness of the treatment and to document any lasting effects.

Who can join the trial?

18 criteria

  • Must have signed an Informed Consent Form, which means you agree to participate in the study after understanding all the details.
  • Must have certain laboratory test results within normal limits or not too abnormal, including tests for liver function, kidney function, and blood components.
  • Women who can have children must have a negative pregnancy test before starting the study.
  • No untreated or partially treated varices, which are swollen veins that can bleed, as confirmed by a recent medical examination.
  • No other severe health conditions that could interfere with the study.
  • Any side effects from previous treatments must be mild or resolved, except for hair loss.
  • If you have active hepatitis B, your virus levels must be low, and you must be on treatment for at least 14 days before starting the study.
  • If you have active hepatitis C, you can participate if you have been treated before the study, but not during the study.
  • Women who can have children must agree to use effective birth control or not have heterosexual intercourse during the study and for a certain period after the study ends.
  • Men must agree to use birth control methods with partners who can have children and not donate sperm during the study and for a certain period after the study ends.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of hepatocellular carcinoma, a type of liver cancer, based on specific medical tests.
  • Must have intermediate-stage liver cancer that cannot be treated with surgery or liver transplant but can be treated with a procedure called TACE.
  • Can have cancer that has come back after previous treatments if more TACE is needed.
  • Must have a Child-Pugh score of class A or B7, which is a way to measure liver function, without needing high doses of a medication called spironolactone.
  • Must have an ECOG performance status of 0-1, which means you are fully active or have some symptoms but can still do light work.
  • Must have adequate organ and bone marrow function, meaning your organs and bone marrow are working well enough.
  • Must have a life expectancy of at least 3 months.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer besides intermediate-stage liver cancer cannot participate.
  • Patients who have had previous treatments that might interfere with the study cannot participate.
  • Patients with severe heart problems cannot participate.
  • Patients with uncontrolled high blood pressure cannot participate.
  • Patients with active infections that require treatment cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of severe allergic reactions to similar medications cannot participate.
  • Patients with any other serious medical conditions that might affect the study cannot participate.
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Investigated drugs

  • Atezolizumab

    is a medication used in this trial to help the body's immune system attack cancer cells. It works by blocking a protein that stops the immune system from working properly, allowing it to better target and destroy cancer cells.

  • Bevacizumab

    is another medication used in combination with atezolizumab. It works by blocking the growth of new blood vessels that tumors need to grow and spread. This helps to slow down or stop the growth of cancer.

  • Transarterial Chemoembolization (TACE)

    is a procedure used in this trial as a comparison to the medications. It involves delivering chemotherapy directly to the liver tumor through the blood vessels, while also blocking the blood supply to the tumor. This helps to shrink the tumor and limit its growth.

What is already known about the treatment

  • Atezolizumab

    Atezolizumab is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness in treating intermediate-stage liver cancer, specifically hepatocellular carcinoma. The medication works by blocking a protein called PD-L1, which helps the immune system detect and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

  • Bevacizumab

    Bevacizumab is also administered intravenously. It is being evaluated in combination with atezolizumab for treating intermediate-stage hepatocellular carcinoma. Bevacizumab works by inhibiting a protein called VEGF, which is involved in the growth of blood vessels that supply nutrients to tumors. This medication is classified as an angiogenesis inhibitor, which means it helps to prevent the formation of new blood vessels that tumors need to grow.

Investigated diseases

Intermediate-stage Hepatocellular Carcinoma – This is a type of liver cancer that occurs when malignant cells form in the tissues of the liver. It is considered intermediate-stage when the cancer has not spread to distant parts of the body but may have grown into nearby blood vessels or lymph nodes. Patients at this stage often have multiple tumors in the liver, and the liver function is usually still adequate. The disease progresses as the tumors grow larger or increase in number, potentially affecting liver function over time. Symptoms may include abdominal pain, weight loss, and jaundice, although some individuals may not experience noticeable symptoms initially. The progression can vary, and monitoring is essential to manage the condition effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512953-26-00Protocol codeABC-HCCEstimated enrolment320 patientsSponsorInstitut fuer Klinische Krebsforschung IKF GmbH

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