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Study on the Effect of Durvalumab and Tremelimumab with Radioactive Glass Spheres in Patients with Non-Resectable 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 the effects of two immunotherapy drugs, Durvalumab and Tremelimumab, in combination with a treatment involving radioactive glass spheres, on patients with a type of liver cancer known as Hepatocellular Carcinoma (HCC). The purpose of the study is to evaluate how well these treatments work together in patients whose liver cancer cannot be removed by surgery. The study will compare different treatment strategies, including personalized and standard doses of the radioactive glass spheres, as well as immunotherapy followed by additional treatment as needed.

Participants in the study will receive the treatments over a period of time, with Durvalumab being administered for up to 12 months and Tremelimumab for a shorter duration. The study will monitor the response of the cancer to these treatments, as well as the overall survival and progression of the disease. The study aims to understand how these combined treatments can improve the quality of life and control the disease in patients with non-resectable liver cancer.

Throughout the study, various aspects of the patients' health will be observed, including how long they live without the cancer getting worse and how the treatments affect their liver function. The study will also assess the time it takes for the cancer to progress to a more advanced stage and how the treatments impact the patients' overall well-being. The findings from this study could provide valuable insights into new treatment options for liver cancer patients.

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, eligibility is confirmed based on specific criteria such as a diagnosis of hepatocellular carcinoma (HCC), a life expectancy of at least 12 weeks, and preserved liver function.

    The study involves patients whose disease cannot be treated with surgery or ablation but is eligible for a treatment called TACE, with a tumor burden of less than 50% of liver volume.

  2. Step 2

    Treatment initiation

    The treatment begins with the administration of two immunotherapy drugs: tremelimumab and durvalumab. These are given as a solution for infusion, which means they are delivered directly into the bloodstream through a vein.

    The specific dosage and frequency of these medications are determined by the study protocol and are administered under medical supervision.

  3. Step 3

    Combination with SIRT

    The immunotherapy is combined with a treatment called SIRT, which stands for Selective Internal Radiation Therapy. This involves using radioactive glass spheres to target cancer cells in the liver.

    The study explores different approaches to SIRT: personalized SIRT (p-SIRT), standard-dose SIRT (sd-SIRT), or immunotherapy followed by on-demand loco-regional SIRT (od-SIRT).

  4. Step 4

    Monitoring and assessment

    Throughout the study, the response to treatment is closely monitored. This includes assessing the objective response rate, which measures how well the cancer responds to the treatment compared to historical data.

    Secondary assessments include overall survival, progression-free survival, and quality of life, among others. These are evaluated using specific questionnaires and medical tests.

  5. Step 5

    Study duration

    The study is expected to continue until December 31, 2026. During this time, regular follow-ups and assessments are conducted to gather data on the effectiveness and safety of the treatment.

    Participants are monitored for any changes in liver function and disease progression, ensuring that any adverse effects are managed promptly.

Who can join the trial?

7 criteria

  • Must have a confirmed diagnosis of hepatocellular carcinoma (a type of liver cancer).
  • Must have a life expectancy of at least 12 weeks.
  • The disease should not be treatable with surgery or other curative methods, but should be suitable for a treatment called TACE (a procedure that delivers chemotherapy directly to the liver) with less than 50% of the liver affected by the tumor.
  • Must have an ECOG performance status of 0 or 1, which means the patient is fully active or has some symptoms but can still carry out light work.
  • Must have good liver function, indicated by a Child-Pugh score of A (a scoring system to assess liver disease) and a serum Bilirubin level less than 1.5 times the normal upper limit (Bilirubin is a substance made by the liver).
  • Must be within the age range of 18 to 64 years old.
  • Both male and female patients are eligible to participate.

Who cannot join the trial?

5 criteria

  • Patients with other types of cancer besides hepatocellular carcinoma cannot participate. Hepatocellular carcinoma is a type of liver cancer.
  • Patients who have had surgery to remove the liver cancer are not eligible. Non-resectable means the cancer cannot be removed by surgery.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to give informed consent or understand the study details are excluded. This ensures that participants fully understand what the study involves.
  • Patients with certain medical conditions or treatments that might interfere with the study results are not eligible. This is to ensure the safety and accuracy of the study.
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Investigated drugs

  • Durvalumab

    is a medication used in this trial 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, thereby enhancing the body's natural defenses against cancer.

  • Tremelimumab

    is another medication in the trial that also helps the immune system target and destroy cancer cells. It works by inhibiting a protein that can suppress the immune response, allowing the immune system to better recognize and attack cancer cells.

  • Personalized SIRT (p-SIRT)

    is a therapy that involves delivering radiation directly to the liver tumors. This personalized approach aims to maximize the treatment's effectiveness by tailoring it to the specific characteristics of the patient's cancer.

  • Standard-dose SIRT (sd-SIRT)

    is a form of radiation therapy that targets liver tumors with a standard amount of radiation. This method is used to shrink tumors and control cancer growth.

  • On-demand loco-regional SIRT (od-SIRT)

    is a treatment strategy where radiation is delivered to liver tumors as needed, based on the patient's response to initial treatments. This approach allows for flexibility in managing the cancer based on its progression and the patient's condition.

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 non-resectable hepatocellular carcinoma, a type of liver cancer. It is an immunotherapy drug that works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. By inhibiting this protein, durvalumab allows the immune system to better recognize and attack cancer cells. It is classified as a monoclonal antibody and is part of a class of drugs known as immune checkpoint inhibitors.

  • Tremelimumab

    This medication is also given intravenously and is under investigation in clinical trials for its potential use in treating non-resectable hepatocellular carcinoma. Tremelimumab is an immunotherapy agent that targets the CTLA-4 protein on T-cells, a type of immune cell. By blocking CTLA-4, tremelimumab enhances the immune response against cancer cells. It belongs to the pharmacological class of monoclonal antibodies and is considered 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 infection. The disease typically progresses by forming a mass in the liver, which can grow and spread to other parts of the body. As it advances, it may cause symptoms like abdominal pain, weight loss, and jaundice. The progression can lead to complications such as liver failure or metastasis to other organs. Early stages might not present noticeable symptoms, making regular monitoring crucial for those at risk.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515127-11-00Protocol codeESR-19-14451Estimated enrolment64 patientsSponsorKlinikum Der Universitat Munchen AöR

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