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Study on the Safety and Effects of Durvalumab, Tremelimumab, and Bevacizumab in Patients with Advanced Liver Cancer

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 treatments for advanced liver cancer, specifically a type called Hepatocellular Carcinoma. The study will explore the safety and effects of different medications, including Durvalumab (also known as MEDI4736), Tremelimumab (also known as MEDI1123), and Bevacizumab. These medications are given as solutions through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to assess how safe and tolerable these treatments are when used alone or in combination. Participants will receive either one of the medications by itself or a combination of Durvalumab with either Tremelimumab or Bevacizumab. Some participants may receive a placebo, which is a substance with no active medication. The study will monitor participants over a period to observe any side effects and how the cancer responds to the treatment.

Throughout the study, participants will undergo regular health checks, including blood tests and imaging scans like MRI or CT scans, to track their health and the progress of the cancer. The study aims to gather information on how these treatments can help manage advanced liver cancer and improve patient outcomes. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to provide written informed consent, which means you agree to participate after understanding the study's purpose and procedures.

  2. Step 2

    Screening tests

    You will undergo various screening tests to ensure you meet the study's eligibility criteria. These tests may include blood tests, imaging scans like CT or MRI, and a review of your medical history.

  3. Step 3

    Treatment assignment

    Once eligibility is confirmed, you will be assigned to a treatment group. The study involves different treatments: durvalumab and tremelimumab as monotherapy, or durvalumab combined with tremelimumab or bevacizumab.

  4. Step 4

    Treatment administration

    You will receive the assigned treatment through an intravenous infusion. The frequency and duration of the treatment will depend on the specific group you are in. The study team will provide detailed instructions on the schedule.

  5. Step 5

    Regular monitoring

    Throughout the trial, you will have regular visits for monitoring. This includes checking your health status, conducting blood tests, and possibly imaging scans to assess the treatment's effects.

  6. Step 6

    Reporting side effects

    You will be asked to report any side effects or changes in your health to the study team. This information is crucial for assessing the safety and tolerability of the treatments.

  7. Step 7

    End of treatment

    After completing the treatment phase, you will have a final visit to evaluate your overall health and the study's impact. The study team will discuss the next steps and any follow-up care needed.

Who can join the trial?

22 criteria

  • Must be a male or female aged 18 years or older (20 years or older in Japan).
  • Must agree to provide a sample of tumor tissue for research purposes.
  • Must have adequate organ and bone marrow function. This means:
    • Hemoglobin level of at least 9 g/dL.
    • White blood cell count (absolute neutrophil count) of at least 1,000/µL.
    • Platelet count of at least 75,000/µL.
    • Total bilirubin (a liver function test) no more than 2 times the normal limit.
    • AST and ALT (liver enzymes) no more than 5 times the normal limit.
    • Albumin (a protein in the blood) level of at least 2.8 g/dL.
    • International Normalized Ratio (a blood clotting test) of 1.6 or less.
    • Creatinine clearance (a kidney function test) of at least 50 mL/minute.
    • Females who can have children must use a highly effective method of birth control during the study and for a period after the last dose of the study drug. This also applies to their male partners.
    • Non-sterilized males must use a highly effective method of birth control if they have a female partner who can have children, during the study and for a period after the last dose of the study drug.
    • Must weigh more than 30 kg (about 66 pounds).
    • Must have a life expectancy of at least 12 weeks.
    • Must provide written informed consent to participate in the study.
    • Must have a confirmed diagnosis of Hepatocellular Carcinoma (HCC), which is a type of liver cancer.
    • Must not have received certain prior treatments for HCC, or must have stopped responding to or refused such treatments.
    • Must have a Child-Pugh Score of class A, which is a measure of liver function.
    • Must have an ECOG performance status of 0 or 1, which indicates the level of daily functioning.
    • If infected with Hepatitis B, must be on antiviral therapy to control the infection.
    • If infected with Hepatitis C, must have a confirmed diagnosis.
    • Must have at least one measurable tumor that has not been treated with radiation.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than Hepatocellular Carcinoma (a type of liver cancer).
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to give informed consent or understand the study requirements.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medications.
  • Patients who have had a recent major surgery.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of drug or alcohol abuse.
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Investigated drugs

  • Durvalumab

    is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, it is being tested to see how safe and effective it is for people with advanced liver cancer when used alone or in combination with other treatments.

  • Tremelimumab

    is another immunotherapy medication. It helps your immune system fight cancer by targeting specific proteins that can slow down your immune response. This trial is exploring how well it works on its own and when combined with other treatments for advanced liver cancer.

  • Bevacizumab

    is a medication that works by blocking the growth of new blood vessels that tumors need to grow. By cutting off the blood supply, it can help slow down or stop the growth of cancer. In this study, it is being used in combination with other treatments to see if it can improve outcomes for people with advanced liver cancer.

What is already known about the treatment

  • Durvalumab

    Durvalumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied for its safety and effectiveness in treating advanced liver cancer, specifically hepatocellular carcinoma. The medication works by helping the immune system recognize and attack cancer cells, blocking a protein that usually helps cancer cells hide from the immune system. Durvalumab is classified as an immunotherapy drug, which is a type of treatment that uses the body's own immune system to fight cancer.

  • Tremelimumab

    Tremelimumab is also given as an intravenous infusion, allowing it to enter the bloodstream directly. It is being researched for its potential to treat advanced liver cancer, known as hepatocellular carcinoma. This medication helps the immune system target and destroy cancer cells by inhibiting a protein that normally suppresses immune responses. Tremelimumab is part of the immunotherapy class of drugs, which are designed to boost the body's natural defenses against cancer.

  • Bevacizumab

    Bevacizumab is administered through an intravenous infusion, which means it is delivered directly into the bloodstream. It is being evaluated for its role in treating advanced liver cancer, specifically hepatocellular carcinoma, when used in combination with other medications. Bevacizumab works by blocking a protein that helps tumors form new blood vessels, effectively starving the cancer of the nutrients it needs to grow. It is classified as an anti-angiogenic drug, which means it prevents the formation of new blood vessels that supply tumors.

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, particularly in individuals with cirrhosis due to hepatitis B or C infection, or alcohol abuse. The disease typically progresses by forming a mass in the liver, which can grow and spread to other parts of the body. As the tumor enlarges, it may cause symptoms such as abdominal pain, weight loss, and jaundice. Over time, the cancer can invade blood vessels and metastasize to other organs, complicating the condition. The progression of hepatocellular carcinoma can vary, with some tumors growing slowly and others advancing rapidly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517085-41-00Protocol codeD4190C00022Estimated enrolment11 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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