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Study of Durvalumab, Tremelimumab, and Lenvatinib with TACE for Patients with Liver Cancer (Hepatocellular Carcinoma)

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 locoregional hepatocellular carcinoma (HCC). The study is exploring the effectiveness of a combination of treatments compared to a standard procedure called transarterial chemoembolization (TACE). The treatments being tested include Durvalumab, also known by its code name MEDI4736, Tremelimumab, and Lenvatinib. These treatments are being used together with TACE to see if they can improve outcomes for patients with this type of liver cancer.

The purpose of the study is to determine if the combination of these treatments is better than TACE alone in helping patients live longer without their cancer getting worse. The study will involve patients receiving either the combination of treatments or TACE alone. Some patients may also receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments. The study will take place over a period of time, with regular check-ups and assessments to monitor the patients' health and the progress of their cancer.

Participants in the study will receive the treatments through different methods. Durvalumab and Tremelimumab are given as a solution for infusion, which means they are administered directly into the bloodstream through a vein. Lenvatinib is taken orally in the form of hard capsules. The study aims to provide valuable information on whether this combination of treatments can offer a better option for patients with locoregional hepatocellular carcinoma.

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 such as the absence of disease outside the liver and the ability to undergo a procedure called transarterial chemoembolization (TACE).

  2. Step 2

    Initial treatment phase

    The initial treatment involves the administration of durvalumab and tremelimumab through an intravenous infusion. This means the medication is delivered directly into the bloodstream through a vein.

    In some cases, lenvatinib is also given. This medication is taken orally in the form of capsules.

  3. Step 3

    Transarterial chemoembolization (TACE)

    TACE is a procedure used to treat liver cancer. It involves delivering chemotherapy directly to the liver tumor and blocking the blood supply to the tumor.

  4. Step 4

    Ongoing treatment

    The treatment with durvalumab and tremelimumab continues, with the potential addition of lenvatinib as prescribed by the study protocol.

    The frequency and duration of these treatments are determined by the study guidelines and the patient's response to the treatment.

  5. Step 5

    Monitoring and assessment

    Regular monitoring is conducted to assess the progression of the disease and the patient's overall health. This includes imaging tests and other evaluations as required by the study.

  6. Step 6

    Completion of study participation

    The study is estimated to conclude by February 26, 2027. Participation may end earlier based on individual circumstances or study requirements.

Who can join the trial?

9 criteria

  • The patient must have **locoregional hepatocellular carcinoma (HCC)**, which is a type of liver cancer that has not spread beyond the liver.
  • There should be **no evidence of extrahepatic disease**, meaning the cancer has not spread outside the liver.
  • The disease should not be treatable with **curative surgery, transplantation, or curative ablation**. This means the cancer cannot be completely removed or destroyed by these methods.
  • The disease must be treatable with **TACE**, a procedure that delivers chemotherapy directly to the liver.
  • The patient should have a **Child-Pugh score class A**, which indicates good liver function, and an **ECOG performance status of 0 or 1**, meaning the patient is fully active or has some symptoms but can still carry out light work.
  • The disease must be **measurable by mRECIST criteria**, which are specific guidelines used to assess the size and response of tumors.
  • The patient must have **adequate organ and marrow function**, meaning their organs and bone marrow are working well enough to handle the treatment.
  • Both **male and female** patients can participate.
  • The study includes patients from certain age groups, typically adults.

Who cannot join the trial?

7 criteria

  • Patients who have other types of cancer besides locoregional hepatocellular carcinoma (HCC). This is a type of liver cancer that is limited to a specific area.
  • Patients who have had previous treatments that might interfere with the study results.
  • Patients with serious health conditions that could make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have allergies to the study medications.
  • Patients who are participating in another clinical trial at the same time.
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Investigated drugs

Durvalumab is a medication used to help the immune system detect and fight cancer cells. It works by blocking a specific protein that prevents the immune system from attacking cancer cells, allowing the body to better target and destroy them. Tremelimumab is another medication that helps the immune system fight cancer. It works by targeting a protein that can suppress the immune response, thereby enhancing the body's ability to attack cancer cells. Lenvatinib is a medication that helps slow down the growth of cancer cells. It works by blocking certain proteins that cancer cells need to grow and spread, which can help control the progression of the disease. Transarterial Chemoembolization (TACE) is a procedure used to treat liver cancer. It involves delivering chemotherapy directly to the liver tumor through the blood vessels, while also blocking the blood supply to the tumor to help shrink it.

What is already known about the treatment

  • Durvalumab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating locoregional hepatocellular carcinoma (HCC). It is an immune checkpoint inhibitor that works by blocking the PD-L1 protein, helping the immune system to detect and attack cancer cells. Durvalumab is classified as a monoclonal antibody and is being evaluated for its potential to improve progression-free survival in combination with other treatments.

  • Tremelimumab

    Administered intravenously, tremelimumab is under investigation in clinical trials for locoregional hepatocellular carcinoma (HCC). It functions as an immune checkpoint inhibitor by targeting the CTLA-4 protein, which enhances the immune system's ability to fight cancer. Tremelimumab is a monoclonal antibody and is being studied for its potential to improve treatment outcomes when used with other therapies.

  • Lenvatinib

    This medication is taken orally and is being explored in clinical trials for its role in treating locoregional hepatocellular carcinoma (HCC). Lenvatinib is a tyrosine kinase inhibitor that works by blocking certain proteins involved in cancer cell growth and blood vessel formation. It is classified as a targeted therapy and is being assessed for its effectiveness in combination with other treatments to improve patient outcomes.

Investigated diseases

Locoregional Hepatocellular Carcinoma (HCC) – This is a type of liver cancer that originates in the liver cells and is confined to the liver and its surrounding region. It typically begins as a single tumor or multiple small tumors within the liver. As the disease progresses, the cancerous cells can invade nearby blood vessels and tissues. The growth of these tumors can lead to liver dysfunction and may cause symptoms such as abdominal pain, weight loss, and jaundice. Over time, the cancer may spread to nearby lymph nodes or other parts of the body. The progression of the disease can vary, with some cases remaining stable for a period before advancing.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508701-24-00Protocol codeD910VC00001Estimated enrolment725 patientsSponsorAstraZeneca AB

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