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Study on the Safety and Effectiveness of TheraSphere, Durvalumab, and Tremelimumab 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 the treatment of Hepatocellular Carcinoma (HCC), which is a type of liver cancer. The study will use a combination of treatments starting with a special type of radiation therapy called TheraSphere, followed by two medications: durvalumab (also known as Imfinzi) and tremelimumab (also known as Imjudo). These medications are part of a group of treatments known as immunotherapy, which helps the body's immune system fight cancer.

The purpose of the study is to evaluate how effective and safe this combination of treatments is for patients with HCC. Participants will first receive the TheraSphere treatment, which involves delivering tiny radioactive beads directly to the liver tumor. After this, they will receive the immunotherapy drugs durvalumab and tremelimumab through an infusion, which is a way of delivering medication directly into the bloodstream. The study will monitor the participants over a period to see how well the treatment works and to check for any side effects.

Throughout the study, doctors will assess the response of the cancer to the treatment using imaging techniques and other medical evaluations. The study aims to understand the overall response rate, which includes complete and partial responses to the treatment, and to track any adverse events or serious side effects that may occur. This research will help determine if this combination of treatments can be a beneficial option for people with HCC.

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, the patient will undergo initial assessments to confirm eligibility. This includes checking liver function, blood counts, and overall health status.

    The patient must provide written informed consent before any study-related procedures begin.

  2. Step 2

    TheraSphere treatment

    The patient will receive a treatment called TheraSphere, which involves delivering radiation directly to the liver tumor. This is done through a procedure that targets the tumor with tiny glass beads containing radioactive material.

  3. Step 3

    Immunotherapy with durvalumab and tremelimumab

    Following the TheraSphere treatment, the patient will begin immunotherapy. This involves receiving two medications: durvalumab and tremelimumab.

    Durvalumab is administered as a solution for infusion at a concentration of 50 mg/mL. Tremelimumab is also given as a solution for infusion at a concentration of 20 mg/mL.

    These medications are given through an infusion, which is a method of delivering medication directly into the bloodstream over a set period.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the patient's health and response to treatment will be closely monitored. This includes regular check-ups and imaging tests to assess the tumor's response.

    The patient will also be monitored for any side effects or adverse reactions to the treatments.

  5. Step 5

    End of study

    The study is expected to conclude by July 2027. At the end of the study, the patient's overall health and treatment outcomes will be evaluated.

    The patient may receive additional follow-up care as needed based on their health status and response to the treatments.

Who can join the trial?

29 criteria

  • Participants must be at least 18 years old at the time of screening.
  • Must have proper kidney and bone marrow function, which includes:
    • Hemoglobin (a protein in red blood cells) level of at least 9.0 grams per deciliter.
    • Absolute neutrophil count (a type of white blood cell) of at least 1.0 x 109 per liter.
    • Platelet count (cells that help with blood clotting) of at least 50 x 109 per liter.
    • Creatinine clearance (a measure of kidney function) of at least 40 milliliters per minute.
    • Absolute lymphocyte count (another type of white blood cell) of at least 0.5 x 109 per liter.
    • Must provide written informed consent and any necessary local authorizations before any study-related procedures.
    • Must have proper liver function, which includes:
      • Child-Pugh A (a score used to assess liver disease severity).
      • Albumin-bilirubin (ALBI) score of -2 or less, with some exceptions for certain conditions like Gilbert's syndrome.
      • AST and ALT (liver enzymes) levels less than 3 times the upper limit of normal.
      • Body weight must be more than 30 kilograms and body mass index (BMI) of at least 18 kg/m2.
      • Life expectancy of at least 6 months.
      • Must have hepatocellular carcinoma (HCC), diagnosed by imaging or tissue sample.
      • Not a candidate for liver surgery, thermal ablation, or liver transplant at the time of study entry.
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which indicates the level of daily functioning.
      • At least one HCC lesion that can be measured by specific criteria (mRECIST).
      • Dosimetry criteria for tumors and normal tissue must be determined.
      • Tumor volume must be 35% or less of the whole liver volume.
      • Future remnant liver volume (FRLV) must be 30% or more of the whole liver volume.
      • Patients with past episodes of fluid buildup in the abdomen (ascites) or brain function changes (encephalopathy) should be symptom-free and not on supportive treatment at study entry.
      • Patients with previous liver surgery or treatment must have completed it at least 6 months before starting the study treatment.
      • Previous transarterial chemoembolization (TACE) is allowed if:
        • It was done at least 8 months before starting the study treatment.
        • The result was a complete response (CR).
        • The current tumor is not a recurrence of the previously treated lesion.
        • No portal vein thrombosis (PVT) or specific types (Vp0, Vp1, or Vp2) are allowed.
        • Patients with hepatitis B (HBV) or hepatitis C (HCV) must have documented virus levels and receive appropriate treatment.
        • Patients with HIV are eligible if the infection is well controlled and there are no AIDS-related complications, with CD4+ T-cell counts of at least 350 cells per microliter.
        • Negative pregnancy test for females who can have children.
        • Must use adequate contraception for the patient and their sexual partner.

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 follow the study procedures or attend the required visits.
  • Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have an allergy or reaction to the study medications.
  • Patients who have a history of certain heart, lung, or other serious health problems.
  • Patients who are taking medications that might interfere with the study treatment.
  • Patients who have an active infection that requires treatment.
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Investigated drugs

  • TheraSphere

    is a type of therapy that uses tiny glass beads filled with a radioactive substance. These beads are delivered directly to the liver to target and destroy cancer cells in patients with hepatocellular carcinoma (HCC). This treatment aims to reduce the size of the tumor and limit its growth.

  • Durvalumab (Imfinzi®)

    is a medication that helps the immune system recognize and attack cancer cells. It is used to treat certain types of cancer by blocking a protein that prevents the immune system from attacking cancer cells. In this trial, it is used after TheraSphere to enhance the body's immune response against liver cancer.

  • Tremelimumab (Imjudo®)

    is another medication that works with the immune system to fight cancer. It targets a specific protein on immune cells, helping them to better identify and destroy cancer cells. In this trial, it is used in combination with durvalumab to improve the effectiveness of the immune response in treating hepatocellular carcinoma.

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 hepatocellular carcinoma, a type of liver cancer. It is an approved immunotherapy drug that works by blocking a protein called PD-L1, which helps the immune system detect and attack cancer cells. Durvalumab is classified as a monoclonal antibody and is used to enhance the body's immune response against cancer.

  • Tremelimumab

    This medication is also given intravenously and is under investigation in clinical trials for hepatocellular carcinoma. It is an immunotherapy drug that targets the CTLA-4 protein, which can inhibit the immune system's ability to fight cancer. By blocking CTLA-4, tremelimumab helps activate the immune system to attack cancer cells. It is classified as a monoclonal antibody and is used to boost the immune response in cancer treatment.

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. 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 like abdominal pain, weight loss, and jaundice. The progression of the disease can lead to liver dysfunction and complications related to the spread of cancer cells. Early stages may not present noticeable symptoms, making regular monitoring crucial for those at risk.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508945-41-00Protocol codeS2472Estimated enrolment110 patientsSponsorBiocompatibles UK Limited

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