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Study of Atezolizumab, Bevacizumab, and Tiragolumab for Patients with Untreated Advanced or Metastatic 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 Hepatocellular Carcinoma (HCC). The study is evaluating the effectiveness of a combination of medications, including Atezolizumab, Bevacizumab, and Tiragolumab. Atezolizumab and Bevacizumab are already used in treating certain cancers, while Tiragolumab is being tested for its potential benefits. Some participants will receive a placebo instead of Tiragolumab to help researchers understand the effects of the actual medication.

The purpose of the study is to assess how well these medications work together in patients who have not yet received treatment for their advanced or spreading liver cancer. Participants will receive the medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will compare the outcomes of those receiving the full combination of medications to those receiving only Atezolizumab and Bevacizumab, with or without Tiragolumab.

Throughout the study, participants will be monitored to see how their cancer responds to the treatment and to track their overall health. The study aims to determine if the combination of these medications can help control the cancer and improve survival rates. The trial will continue for a set period, during which participants will have regular check-ups and assessments to ensure their safety and to gather important data on the treatment's effectiveness.

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, eligibility is confirmed based on specific criteria, including the diagnosis of hepatocellular carcinoma (HCC) and other health assessments.

    Participants must have no prior systemic treatment for HCC and meet other health and virology status requirements.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the combination of atezolizumab, bevacizumab, and tiragolumab or atezolizumab and bevacizumab alone.

    This process is double-blind, meaning neither the participants nor the researchers know which treatment is being administered.

  3. Step 3

    Treatment administration

    The medications are administered through intravenous infusion. Atezolizumab is given as a 1,200 mg solution, and bevacizumab is provided as a 25 mg/ml concentrate.

    Tiragolumab, if included in the treatment, is also administered via infusion. The frequency and duration of these infusions are determined by the study protocol.

  4. Step 4

    Monitoring and assessments

    Participants undergo regular monitoring to assess the progression of the disease and overall health status.

    This includes evaluating progression-free survival (PFS) and overall survival (OS), as well as other health indicators.

  5. Step 5

    Follow-up

    Participants continue to be monitored for any adverse effects and the effectiveness of the treatment.

    The study aims to collect data on the incidence and severity of any side effects, as well as the presence of anti-drug antibodies.

  6. Step 6

    Completion of the study

    The study is estimated to conclude by September 2026, with ongoing assessments and data collection until that time.

    Final evaluations will be conducted to determine the overall outcomes and effectiveness of the treatments.

Who can join the trial?

10 criteria

  • The patient must have **Hepatocellular Carcinoma (HCC)**, which is a type of liver cancer.
  • The cancer must be **locally advanced** (spread within the liver) or **metastatic** (spread to other parts of the body) and/or **unresectable** (cannot be removed by surgery). The diagnosis should be confirmed by a tissue sample or specific clinical criteria for liver disease.
  • The patient should not have received any previous **systemic treatment** (treatment that affects the whole body) for their advanced or metastatic liver cancer.
  • The patient must have a **measurable disease**, meaning there is at least one tumor that can be measured to see if it changes in size during the study.
  • The patient should have an **ECOG performance status** of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • The patient must be **Child-Pugh Class A**, indicating good liver function.
  • The patient should have **adequate hematologic and end-organ function**, meaning their blood and organs are working well enough to participate in the study.
  • The patient must have a **negative HIV test** at the start of the study.
  • The patient must have documented **hepatitis status**, confirmed by tests for hepatitis B and C viruses.
  • Both male and female patients must agree to use specific methods of **contraception** during the study.

Who cannot join the trial?

7 criteria

  • Patients with other types of cancer besides Hepatocellular Carcinoma (HCC) cannot participate. HCC is a type of liver cancer.
  • Patients who have had a different cancer treatment recently may not be eligible.
  • Patients with severe heart problems or uncontrolled high blood pressure may be excluded.
  • Patients with serious infections or immune system issues might not be able to join.
  • Pregnant or breastfeeding women are not allowed to participate.
  • Patients with a history of severe allergic reactions to similar medications may be excluded.
  • Patients who are unable to follow the study procedures or attend regular check-ups might not be eligible.
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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 the trial. It works by blocking the growth of new blood vessels that tumors need to grow and spread. By cutting off the blood supply, it helps to slow down or stop the growth of the cancer.

  • Tiragolumab

    is an investigational medication being tested in this trial. It is designed to enhance the immune system's ability to fight cancer by targeting a specific protein that can suppress immune responses. This may help the immune system to better recognize and attack cancer cells.

What is already known about the treatment

  • Atezolizumab

    Atezolizumab is administered intravenously and is currently used in clinical trials for various cancers, including hepatocellular carcinoma. It is an approved medication in the medical literature for certain types of cancer. The main therapeutic indication is to treat advanced or metastatic cancers. Atezolizumab works by blocking the PD-L1 protein, which helps the immune system detect and attack cancer cells. It is classified as an immune checkpoint inhibitor.

  • Bevacizumab

    Bevacizumab is given through intravenous infusion and is widely recognized in medical literature for its role in cancer treatment. It is primarily indicated for use in various types of cancer, including hepatocellular carcinoma. Bevacizumab functions by inhibiting the vascular endothelial growth factor (VEGF), which reduces the blood supply to tumors, thereby slowing their growth. It is classified as an angiogenesis inhibitor.

  • Tiragolumab

    Tiragolumab is administered intravenously and is currently under investigation in clinical trials for its potential use in cancer therapy. It is not yet widely recognized in medical literature as it is still being studied. The main therapeutic indication is for use in combination with other drugs to treat advanced cancers. Tiragolumab targets the TIGIT protein, which may enhance the immune system's ability to fight cancer. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Hepatocellular Carcinoma – Hepatocellular carcinoma 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 B and C infections. 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 of the disease can lead to liver dysfunction and complications related to tumor growth. Early detection is challenging, and the disease is often diagnosed at an advanced stage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503422-39-00Protocol codeCO44668Estimated enrolment659 patientsSponsorF. Hoffmann-La Roche AG

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