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Study of Tremelimumab, Durvalumab, and Drug Combination for Patients with Advanced Liver Cancer

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What is this study about?

This clinical trial is focused on studying treatments for advanced hepatocellular carcinoma (HCC), which is a type of liver cancer. The study will use a combination of treatments including Tremelimumab, Durvalumab (also known as MEDI4736), and a procedure called trans-arterial catheter chemoembolization (TACE). TACE is a method where chemotherapy is delivered directly to the liver tumor through a catheter, which is a thin tube inserted into the body.

The purpose of the study is to evaluate the effectiveness of these treatments in patients with advanced HCC. Participants will receive Tremelimumab on the first day only, followed by Durvalumab and TACE. The study will monitor the patients over a period to see how well the cancer is controlled and to assess the safety of the treatments. The study aims to determine if these treatments can help patients live longer without the cancer getting worse.

Throughout the study, patients will have regular visits and examinations to track their progress and any changes in their health. The study will also explore changes in the immune system by analyzing blood samples over time. This research hopes to provide valuable information on the potential benefits of combining these treatments for people with advanced liver cancer.

1 initial treatment

The study begins with the administration of tremelimumab on Day 1. This medication is given as a single dose through an infusion. Tremelimumab is a type of immunotherapy that helps the immune system fight cancer cells.

2 combination therapy

Following the initial treatment, durvalumab is administered. This medication is also given through an infusion. Durvalumab is another immunotherapy drug that works by blocking a protein that prevents the immune system from attacking cancer cells.

3 trans-arterial catheter chemoembolization (TACE)

The next step involves a procedure called trans-arterial catheter chemoembolization (TACE). This procedure delivers chemotherapy directly to the liver tumor through a catheter, blocking the blood supply to the tumor and allowing the chemotherapy to work more effectively.

4 monitoring and follow-up

Throughout the study, regular monitoring is conducted to assess the response to treatment and any side effects. This includes scheduled visits and examinations. The primary goal is to determine the 6-month progression-free survival, which means the length of time during and after treatment that the cancer does not get worse.

5 study completion

The study is expected to continue until June 2026. During this time, data on safety, overall survival time, and response rates will be collected and analyzed.

Who Can Join the Study?

  • Patients must have a confirmed diagnosis of hepatocellular carcinoma (HCC), which is a type of liver cancer. This can be confirmed through a tissue sample or other medical tests that strongly suggest HCC. A specific type called fibrolamellar variant is also allowed.
  • No previous treatment with systemic therapy for advanced HCC is allowed, except if the patient stopped taking certain medications like sorafenib or lenvatinib due to side effects.
  • Body weight must be more than 30 kilograms.
  • Patients must have normal function of their organs and bone marrow, which includes:
    • Hemoglobin levels of at least 9.0 grams per deciliter (a measure of red blood cells).
    • Absolute neutrophil count (ANC) of at least 1.0 x 109 per liter (a measure of white blood cells).
    • Platelet count of at least 75 x 109 per liter (a measure of cells that help with blood clotting).
    • Serum bilirubin levels no more than 1.5 times the normal limit (a measure related to liver function).
    • AST (SGOT)/ALT (SGPT) levels no more than 2.5 times the normal limit, unless there are liver metastases, in which case it must be no more than 5 times the normal limit (measures of liver enzymes).
    • Creatinine clearance greater than 40 milliliters per minute, which is a measure of kidney function.
  • Patients must have recovered from any side effects of previous treatments, including surgery, to a mild level or back to their normal state.
  • Men and women of all races and ethnic groups can participate.
  • Patients must not have had any other invasive cancers in the past 5 years, except for certain types like non-melanoma skin cancer, non-invasive bladder cancer, or localized prostate cancer that doesn’t need systemic treatment.
  • Patients must be able to understand and agree to sign a written consent form to participate in the study.
  • Female patients must show evidence of being post-menopausal or have a negative pregnancy test if they are pre-menopausal. Post-menopausal status can be confirmed if they have not had a menstrual period for 12 months without another medical reason.
  • Patients must have HCC with disease outside the liver that cannot be removed, transplanted, or destroyed with surgery. The disease should be classified as BCLC group C, which is a staging system for liver cancer.
  • The disease must be suitable for a treatment called transhepatic arterial chemoembolization (TACE), which is a procedure to block the blood supply to the cancer. This decision will be made by a team of specialists.
  • If the patient has liver cirrhosis, a condition where the liver is scarred, they must have a classification of Child-Pugh A or B7, which are measures of liver function.
  • Patients must be older than 18 years.
  • Patients must have an ECOG performance status of 0-1, which means they are fully active or have some symptoms but can still carry out light work. They must also have a life expectancy of at least 12 weeks.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than Advanced Hepatocellular Carcinoma (HCC). HCC is a type of liver cancer.
  • Patients who have not been treated with TACE. TACE stands for Transarterial Chemoembolization, a treatment that delivers chemotherapy directly to the liver.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Site Name City Country Status
Mater Misericordiae University Hospital Dublin Ireland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Ireland Ireland
Not recruiting
01.04.2024

Trial locations

Investigated drugs:

Tremelimumab is a medication used in this trial to help the body’s immune system fight cancer cells. It is given to patients on the first day of the study. Tremelimumab works by blocking a specific protein that can stop the immune system from attacking cancer cells, allowing the immune system to better target and destroy these cells.

Durvalumab is another medication used in this trial. It is designed to help the immune system recognize and attack cancer cells more effectively. Durvalumab works by blocking a protein that cancer cells use to hide from the immune system, making it easier for the body to fight the cancer.

Trans-arterial catheter chemoembolization (TACE) is a procedure used in this trial to treat liver cancer. It involves delivering chemotherapy directly to the liver tumor through a catheter, which is a thin tube. This method helps to block the blood supply to the tumor, causing it to shrink and die, while also delivering high doses of chemotherapy directly to the cancer cells.

Investigated diseases:

Advanced Hepatocellular Carcinoma – This is a type of liver cancer that occurs when malignant cells form in the tissues of the liver. It is considered advanced when the cancer has spread beyond the liver to other parts of the body or when it cannot be removed surgically. The disease often progresses as the cancer cells grow and invade nearby tissues or spread to distant organs. Symptoms may include weight loss, loss of appetite, upper abdominal pain, and jaundice. As the disease advances, it can lead to liver dysfunction and other complications. The progression of the disease can vary depending on several factors, including the overall health of the liver and the extent of the cancer spread.

Trial ID:
2023-510117-26-00
Protocol code:
UCDCRC/23/06
Trial Phase:
Therapeutic exploratory (Phase II)

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