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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Technische Universitaet Dresden Dresden Germany
Medizinische Hochschule Hannover Hanover Germany
IRCCS Humanitas Research Hospital Rozzano Italy
Universitaetsmedizin Goettingen Goettingen Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Oncopole Claudius Regaud Toulouse France
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E. Vila Real Portugal
Hospital Universitario Ramon Y Cajal Madrid Spain
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
Hospital Universitario Reina Sofía Cordoba Spain
Ospedale San Raffaele S.r.l. Milan Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Hospital Clinic De Barcelona Barcelona Spain
Klinikum Chemnitz gGmbH Chemnitz Germany
Centre Hospitalier Universitaire De Montpellier Montpellier France
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Azienda USL Toscana Sud Est Arezzo Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Universitaetsklinikum Leipzig AöR Leipzig Germany
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Umilxhohly Henugtjzm Phsxm Sezvirisymf Cboqhaw Fhnj Paris France
Uxfvnjfkevgouflbqpihu Dvjakuwmsba Ajh Duesseldorf Germany
Cjeh Dj Nuanf Vandoeuvre Les Nancy France
Hmiavhje Uhhfwgypfafem Dxgdskxz Donostia / San Sebastian Spain
Gkjqaf Uegyeckfac Faqeradtd Frankfurt Germany
Certbs Hbsfvhgnlme Roisrxxp Dpjsghkmgvochk Angers France
Hdtbszai Vycy duvnnwhp Barcelona Spain
Hudjtqyh Uxidctgmjvryhu Sbxwazfdot &qqayzj Hjrqkmt df Hseswemtosa STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
11.03.2024
France France
Not recruiting
11.03.2024
Germany Germany
Not recruiting
11.03.2024
Italy Italy
Not recruiting
11.03.2024
Portugal Portugal
Not recruiting
11.03.2024
Spain Spain
Not recruiting
11.03.2024

Trial locations

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.

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 ID:
2023-508701-24-00
Protocol code:
D910VC00001
NCT ID:
NCT05301842
Trial Phase:
Therapeutic confirmatory (Phase III)

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