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Study on the Effectiveness of Durvalumab and Bevacizumab for Patients with Liver Cancer at High Risk of Recurrence After Surgery or Ablation

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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 designed for patients who have already undergone successful treatment to remove or destroy the cancer, such as surgery or a procedure called ablation. The main goal is to see if the medication durvalumab, either alone or combined with another drug called bevacizumab, can help prevent the cancer from coming back. These medications are given through an infusion, which means they are delivered directly into the bloodstream through a vein.

Participants in the study will be randomly assigned to receive either the medication or a placebo. The study will last for up to 12 months, during which time the participants will receive regular infusions and be closely monitored by the research team. The researchers aim to find out if the treatment can improve the time patients remain free from cancer recurrence, which is known as recurrence-free survival.

The study will also look at other important outcomes, such as overall survival and the time it takes for the cancer to return. By comparing the results of those receiving the medication to those receiving a placebo, the study hopes to provide valuable information on the effectiveness and safety of using durvalumab and bevacizumab as additional therapy for patients with Hepatocellular Carcinoma who are at high risk of the cancer returning.

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, confirmation of a diagnosis of hepatocellular carcinoma (HCC) is required. This includes successful completion of curative therapy, such as resection or ablation.

    Imaging tests are conducted to confirm a disease-free status within 28 days before randomization.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either durvalumab alone or in combination with bevacizumab, or a placebo.

    The purpose is to evaluate the effectiveness of the treatments in preventing cancer recurrence.

  3. Step 3

    Treatment administration

    Durvalumab is administered as an intravenous infusion. The dosage and frequency are determined by the study protocol.

    Bevacizumab is also administered intravenously if assigned to the combination treatment group.

    Participants receiving the placebo will receive an intravenous infusion that does not contain active medication.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the treatment's effectiveness and any side effects.

    Follow-up includes imaging and other tests to evaluate recurrence-free survival and overall survival.

  5. Step 5

    Study completion

    The study is estimated to conclude by May 31, 2027.

    Participants will continue to be monitored for recurrence and overall health outcomes until the study's end.

Who can join the trial?

9 criteria

  • The patient must have a type of liver cancer called Hepatocellular Carcinoma (HCC) that has been confirmed through specific tests.
  • The patient must have completed treatment aimed at curing the cancer, such as surgery to remove the tumor or a procedure to destroy it.
  • The patient must have a test done to show that there is no sign of cancer within 28 days before starting the study.
  • The patient must have a performance status of ECOG 0-1, which means they are fully active or have some symptoms but can still do light work.
  • The patient must have a Child-Pugh score of 5 or 6, which is a way to measure how well the liver is working.
  • If the patient has a Hepatitis B virus (HBV) infection, they must take antiviral medication to control the virus before and during the study, and for 6 months after the last treatment.
  • If the patient has a Hepatitis C virus (HCV) infection, they must be managed according to local medical practices during the study.
  • The patient must have organs and bone marrow that are working well enough, as defined by the study's specific requirements.
  • The study is open to both male and female patients.

Who cannot join the trial?

8 criteria

  • Patients who have not had their liver cancer confirmed through specific tests called histology or cytology. These tests involve examining cells or tissues under a microscope.
  • Patients who have not completed a treatment aimed at curing their liver cancer, such as resection (surgical removal of the tumor) or ablation (destroying the tumor with heat or other methods).
  • Patients who are not within the specified age range for the study.
  • Patients who are not willing or able to follow the study procedures and requirements.
  • Patients who have other medical conditions or are taking medications that might interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a history of certain other diseases or conditions that might affect the study results.
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Investigated drugs

  • Durvalumab

    is a medication used in this trial as a monotherapy or in combination with another drug. It is designed to help the body's immune system detect and fight cancer cells more effectively. In this study, it is being tested to see if it can help prevent the return of liver cancer after surgery or other treatments.

  • Bevacizumab

    is another medication used in combination with durvalumab in this trial. It works by blocking the growth of blood vessels that supply nutrients to tumors, which can help slow or stop the growth of cancer. The study is investigating whether using bevacizumab with durvalumab can improve outcomes for patients who have had liver cancer removed or treated.

What is already known about the treatment

  • Durvalumab

    Durvalumab is administered as an intravenous infusion. It is currently being studied in clinical trials as a potential treatment for hepatocellular carcinoma, particularly for patients at high risk of recurrence after surgery or ablation. The medication works by blocking a protein called PD-L1, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor.

  • Bevacizumab

    Bevacizumab is also given through an intravenous infusion. It is being evaluated in combination with durvalumab for its effectiveness in preventing the recurrence of hepatocellular carcinoma. Bevacizumab functions by inhibiting a protein called VEGF, which is involved in the formation of new blood vessels that tumors need to grow. It is classified as an angiogenesis inhibitor.

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 often develops in the context of chronic liver disease, particularly in individuals with cirrhosis due to hepatitis B or C infection, or alcohol abuse. The disease may initially present with symptoms such as abdominal pain, weight loss, or jaundice. As it progresses, the tumor can grow and spread to other parts of the liver or beyond. Early stages might not show significant symptoms, making it challenging to detect without regular monitoring. The progression of HCC can vary, with some tumors growing slowly while others may advance more rapidly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507689-26-00Protocol codeD910DC00001Estimated enrolment897 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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