Study on Durvalumab and Tremelimumab for Patients with Advanced Liver Cancer Not Treatable by Surgery

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What is this study about?

This clinical trial is focused on studying treatments for advanced liver cancer, specifically a type called hepatocellular carcinoma (HCC). The study is investigating the effectiveness and safety of two immune therapy drugs, durvalumab and tremelimumab, either given alone or together, compared to the standard treatment, sorafenib. These treatments are being tested in patients who have not received any prior systemic therapy for their liver cancer, which means they have not been treated with medications that affect the entire body.

The purpose of the study is to see how well these treatments work and how safe they are for patients with advanced liver cancer that cannot be removed by surgery. Participants in the study will be randomly assigned to receive either durvalumab alone, durvalumab with tremelimumab, or sorafenib. The study will monitor the patients over time to assess their overall survival, which is the length of time they live after starting the treatment, as well as other factors like how long they live without the cancer getting worse.

This study is designed to provide important information about new treatment options for advanced liver cancer. It will help determine if the new immune therapy drugs can offer better outcomes compared to the current standard treatment. The study is expected to continue until the end of 2024, with recruitment of participants starting in mid-2024.

1 joining the study

Upon joining the study, the patient is randomly assigned to one of the treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving any of the treatments being tested.

2 treatment with durvalumab

If assigned to the durvalumab group, the patient receives durvalumab as a solution for infusion. This medication is administered intravenously, meaning it is given through a vein.

The dosage and frequency of administration are determined by the study protocol and are monitored by the healthcare team.

3 treatment with durvalumab and tremelimumab

If assigned to the combination therapy group, the patient receives both durvalumab and tremelimumab as solutions for infusion. Both medications are administered intravenously.

The healthcare team provides specific instructions regarding the dosage and frequency of these medications.

4 treatment with sorafenib

If assigned to the sorafenib group, the patient takes sorafenib in the form of film-coated tablets. This medication is taken orally, meaning it is swallowed.

The dosage and frequency are specified in the study protocol and are overseen by the healthcare team.

5 monitoring and follow-up

Throughout the study, the patient’s health and response to treatment are closely monitored. This includes regular check-ups, tests, and assessments to evaluate the effectiveness and safety of the treatment.

The primary goal is to assess overall survival, which is the time from the start of treatment until death from any cause. Secondary goals include measuring progression-free survival, time to progression, objective response rate, disease control rate, and duration of response.

6 end of study participation

The study is estimated to conclude by December 31, 2024. At the end of the study, the patient’s participation is complete, and the final assessments are conducted to gather data on the treatment’s long-term effects.

Who Can Join the Study?

The patient must have advanced hepatocellular carcinoma (HCC), which is a type of liver cancer.
The diagnosis of HCC must be confirmed through a process called histopathological confirmation, which involves examining tissue under a microscope.
The patient should not have received any prior systemic therapy for HCC. Systemic therapy refers to treatment that affects the entire body, like chemotherapy.
The cancer should be at Barcelona Clinic Liver Cancer (BCLC) stage B (not eligible for local treatments) or stage C. These stages describe the extent of the cancer.
The patient must have a Child-Pugh Score class A, which is a way to assess liver function.
The patient should have an ECOG performance status of 0 or 1 at enrollment. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
The patient must be within the age range of 18 to 64 years old.
Both male and female patients are eligible to participate.
The study may include vulnerable populations, which means groups that might need special protection or care.

Who Cannot Join the Study?

Patients with other types of cancer besides advanced hepatocellular carcinoma (HCC) cannot participate. HCC is a type of liver cancer.
Patients who have received certain treatments for HCC before may not be eligible.
Patients with severe heart problems or uncontrolled high blood pressure are excluded.
Patients with active infections, such as hepatitis B or C, or HIV, cannot join the study.
Patients with autoimmune diseases, where the immune system attacks the body, are not eligible.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to similar medications are excluded.
Patients with brain metastases, which means cancer has spread to the brain, are not eligible.
Patients who have had another cancer within the last 5 years, except for certain skin cancers, cannot join.
Patients with a history of drug or alcohol abuse may be excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Medizinische Hochschule Hannover	Hanover	Germany
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Navarra	Pamplona	Spain
Institut Gustave Roussy	Villejuif	France
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Universitaetsklinikum Aachen AöR	Aachen	Germany
Hopital Beaujon	Clichy	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Uybqhioyurunclzahyood Ekgkl Apj	Essen	Germany
Acefwhx Ohtpzygycze “yt Rlcnzc	Benevento	Italy
Ufiqjucmnq Hmaghbgc Cmnthda	Cologne	Germany
Coja Df Nozha	Vandoeuvre Les Nancy	France
Kvvrnrch dvk Ueepexjqgwnf Maavoxtj Aie	Munich	Germany
Izodabwe di Clwzscjxyxkd Heqcduuzafd Umcejxcnkorsl dt Sudgd Eduqqdt (djcejfc	Saint Priest En Jarez	France
Icbuhnpd Pqaeafcbayhweve Cztlfl Cnzdvw	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	18.06.2024
Germany	Not recruiting	18.06.2024
Italy	Not recruiting	18.06.2024
Spain	Not recruiting	18.06.2024

Trial locations

Investigated drugs:

Durvalumab is an immune therapy drug used in this trial to help the body’s immune system fight advanced liver cancer. It 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.

Tremelimumab is another immune therapy drug used in combination with durvalumab in this trial. It also helps the immune system attack cancer cells by targeting a different protein that can inhibit immune responses. Together with durvalumab, it aims to enhance the body’s ability to fight liver cancer.

Sorafenib is the standard first-line treatment for advanced liver cancer that cannot be removed by surgery. It is a type of medication known as a kinase inhibitor, which works by blocking certain proteins that promote cancer cell growth. In this trial, sorafenib is used as a comparison to evaluate the effectiveness of the new immune therapy drugs.

Investigated diseases:

Hepatocellular carcinoma

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 surgically removed. 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 various factors, including the overall health of the liver and the extent of the cancer spread.

Trial ID:

2024-512212-21-00

Protocol code:

D419CC00002

NCT ID:

NCT03298451

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Durvalumab and Tremelimumab for Patients with Advanced Liver Cancer Not Treatable by Surgery

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