Study of Durvalumab and Tremelimumab with Y-90 SIRT for Patients with Intermediate Stage Liver Cancer

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What is this study about?

This clinical trial is focused on studying a type of liver cancer known as intermediate stage hepatocellular carcinoma (HCC). The study is exploring the effects of two medications, durvalumab (also known by its code name MEDI4736) and tremelimumab, when used together with a treatment called Y-90 SIRT. Y-90 SIRT is a form of radiation therapy that targets the liver. The purpose of the study is to assess how well this combination works in treating patients with this type of liver cancer.

Participants in the study will receive the medications durvalumab and tremelimumab through an intravenous infusion, which means the medicine is given directly into a vein. The study will observe the effects of these medications over a period of time to see how the cancer responds. Some participants may also receive a placebo, which is a substance with no active medication, to compare the results. The study aims to understand the anti-tumor activity of the treatment combination within six months.

The trial will monitor the participants’ health and the cancer’s response to the treatment. This includes regular check-ups and tests to ensure the safety and effectiveness of the treatment. The study is designed to help researchers learn more about how these medications can be used to treat HCC and improve outcomes for patients with this condition.

1 initial treatment phase

The treatment involves the administration of two medications: durvalumab and tremelimumab. These are given as an intravenous (IV) infusion, which means they are delivered directly into the bloodstream through a vein.

The specific dosage and frequency of these medications will be determined by the healthcare team based on individual patient needs and the study protocol.

2 combination with locoregional therapy

In addition to the medications, a procedure called Y-90 SIRT (Selective Internal Radiation Therapy) may be used. This involves delivering radiation directly to the liver tumors.

The combination of the medications and Y-90 SIRT aims to enhance the treatment effect on the liver cancer.

3 monitoring and follow-up

Regular follow-up visits will be scheduled to monitor the response to treatment and any side effects. This includes physical examinations, blood tests, and imaging studies such as CT scans or MRIs.

The primary goal is to assess the objective response rate (ORR) within 6 months, which measures how well the cancer responds to the treatment.

4 completion of study treatment

After completing the treatment phase, further assessments will be conducted to evaluate the overall effectiveness and safety of the treatment.

Patients will continue to be monitored for any long-term effects and overall survival (OS) outcomes.

Who Can Join the Study?

Must be able to provide written consent and any required local authorization before any study-related procedures.
Must have a performance status of 1 or less on the ECOG scale, which measures how well you can perform daily activities.
Must have a life expectancy of at least 12 weeks.
Must have adequate blood counts and organ function, including:
- Hemoglobin level of at least 9.0 g/dL.
- Absolute neutrophil count of at least 1.5 x 10⁹/L.
- Platelets count of at least 75 x 10⁹/L.
- Serum bilirubin level no more than 1.5 times the normal limit.
- AST and ALT levels no more than 2.5 times the normal limit, unless there are liver metastases, then no more than 5 times the normal limit.
- International normalized ratio (INR) of 1.25 or less.
- Albumin level of at least 31 g/L.
- Creatinine clearance greater than 40 mL/min, which measures kidney function.
Female patients who can have children must have a negative pregnancy test and use effective birth control if sexually active.
Men who are sexually active with women who can have children must use effective birth control during the study and for 7 months after the last dose of study drugs.
If you have Hepatitis B or Hepatitis C, you must meet specific criteria and be monitored for viral levels during the study.
Must be willing and able to follow the study protocol, including attending scheduled visits and examinations.
Must be at least 18 years old at the time of study entry.
Must weigh more than 30 kg (about 66 pounds).
Must have multinodular or large, solitary HCC that cannot be removed by surgery or treated with local ablation.
Must have a confirmed diagnosis of HCC through a tissue sample.
Must be scheduled to receive locoregional therapy as part of standard care.
Must have at least one measurable site of disease as defined by specific imaging criteria.
Must not have received any prior systemic anti-cancer therapy.
Must have a Child-Pugh A classification, which assesses liver function.

Who Cannot Join the Study?

Patients who have had previous treatments with systemic anti-cancer therapy. This means any treatment that affects the whole body, like chemotherapy.
Patients who are eligible for resection or local ablation. Resection is a surgery to remove part of the liver, and local ablation is a treatment that destroys cancer cells in a specific area.
Patients with medical conditions that make it unsafe to participate in the study.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who are pregnant or breastfeeding.
Patients with other active cancers that require treatment.
Patients with severe infections or other serious health problems.
Patients who have had a recent heart attack or have severe heart disease.
Patients with a history of severe allergic reactions to similar treatments.
Patients with uncontrolled high blood pressure or diabetes.
Patients with severe liver disease that is not related to the cancer being studied.
Patients with a history of drug or alcohol abuse that could interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
University Hospital Jena KöR	Jena	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Muenchen Klinik gGmbH	Munich	Germany
Ubzukrqqqgqiqvhgmywqt Edhsm Afh	Essen	Germany
Usrwvqqztv Hzxmfinr Cofkzzy	Cologne	Germany
Ulernvgysudhdndetbwbe Mdfpxuub Anj	Munster	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	28.04.2021

Trial locations

Investigated drugs:

Durvalumab is a type of immunotherapy that helps the body’s immune system recognize and attack cancer cells. It is used in this trial to treat liver cancer by enhancing the immune response against the tumor.

Tremelimumab is another immunotherapy drug that works by stimulating the immune system to fight cancer cells. In this trial, it is combined with durvalumab to potentially improve the effectiveness of the treatment for liver cancer.

Y-90 SIRT (Yttrium-90 Selective Internal Radiation Therapy) is a form of radiation therapy that delivers radiation directly to the liver tumor. This therapy aims to shrink the tumor by targeting it with radioactive particles.

DEB-TACE (Drug-Eluting Bead Transarterial Chemoembolization) is a procedure that delivers chemotherapy directly to the liver tumor while blocking its blood supply. This method helps to concentrate the treatment in the tumor area and reduce its size.

Intermediate stage hepatocellular carcinoma (HCC) – This is a type of liver cancer that occurs when malignant cells form in the tissues of the liver. In the intermediate stage, the cancer is typically characterized by multiple tumors or a large solitary tumor that cannot be removed surgically. Patients at this stage are not eligible for local ablation, which is a procedure to destroy cancer cells. The disease progresses as the tumors grow and potentially spread to other parts of the liver or body. It is often diagnosed in individuals with underlying liver conditions such as cirrhosis or chronic hepatitis. The progression of the disease can lead to a decline in liver function over time.

Trial ID:

2024-513950-32-00

Protocol code:

IMMUWIN

NCT ID:

NCT04522544

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Durvalumab and Tremelimumab with Y-90 SIRT for Patients with Intermediate Stage Liver Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?