Study on the Effectiveness of Durvalumab and Bevacizumab with TACE in Patients with Localized Liver Cancer

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What is this study about?

This clinical trial is focused on studying a type of liver cancer called locoregional hepatocellular carcinoma. The study is investigating the effectiveness of a treatment method known as transarterial chemoembolization (TACE) when used in combination with two medications, durvalumab and bevacizumab. Durvalumab, also known by its code name MEDI4736, and bevacizumab are both medications that help the immune system fight cancer. The trial will compare the results of using these medications with TACE against using TACE with a placebo.

The purpose of the study is to see how well the combination of durvalumab and bevacizumab works with TACE in treating this type of liver cancer. Participants in the study will receive treatment over a period of time, and their health will be monitored to assess the effectiveness of the treatment. The study will look at various outcomes, such as how long patients live without the cancer getting worse and their overall survival rates.

Throughout the study, participants will receive the treatments through an intravenous method, which means the medication is given directly into a vein. The study aims to provide valuable information on whether this combination of treatments can improve the management of locoregional hepatocellular carcinoma compared to the current standard treatment options.

1 joining the study

Upon joining the study, participation is confirmed based on specific criteria, including the absence of disease outside the liver and the ability to undergo a procedure called transarterial chemoembolization (TACE).

2 treatment assignment

Participants are randomly assigned to receive either a combination of durvalumab and bevacizumab with TACE or TACE with a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

3 treatment administration

The treatment involves the administration of durvalumab and bevacizumab through an intravenous infusion. The frequency and dosage are determined by the study protocol and are administered under medical supervision.

Participants receiving the placebo will undergo the same procedure without the active medications.

4 monitoring and follow-up

Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects. This includes medical examinations and imaging tests to evaluate the progression of the disease.

Participants are required to attend scheduled follow-up visits as outlined in the study protocol.

5 study completion

The study is expected to continue until August 31, 2026. Participants will be informed about the outcomes and any further steps after the study concludes.

Who Can Join the Study?

The patient must have a type of liver cancer called Locoregional Hepatocellular Carcinoma (HCC).
The cancer should not have spread outside the liver (no evidence of extrahepatic disease).
The cancer cannot be treated with surgery, liver transplant, or a procedure that destroys the cancer cells, but it can be treated with a method called transarterial chemoembolization (TACE).
The patient should have a Child-Pugh score of class A to B7. This score helps doctors understand how well the liver is working.
The patient should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale that measures how well the patient can perform daily activities.
The cancer must be measurable using specific criteria called mRECIST.
The patient must have organs and bone marrow that are working well enough (adequate organ and marrow function).
Both men and women can participate in the study.
The study includes adults, typically those who are 18 years or older.
The study may include people who are considered vulnerable, meaning they might need extra protection or care.

Who Cannot Join the Study?

Patients with other types of cancer besides locoregional hepatocellular carcinoma (HCC) cannot participate. Locoregional hepatocellular carcinoma (HCC) 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 are not eligible.
Individuals with severe or uncontrolled medical conditions that could affect their safety or the study outcomes cannot join.
Patients who are pregnant or breastfeeding are excluded from the study.
Participants who are unable to follow the study procedures or attend the required visits are not eligible.
Individuals with a history of allergic reactions to the study drugs or similar medications cannot participate.
Patients with active infections that require treatment are not eligible.
Individuals with a compromised immune system, which means their body’s defense against infections is weakened, cannot join the study.
Patients who have participated in another clinical trial within a certain time frame before this study are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Navarra	Pamplona	Spain
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hopital Beaujon	Clichy	France
Hôpital Avicenne	Bobigny	France
Universita’ Di Pisa	Pisa	Italy
Centre Hospitalier Universitaire De Nice	Nice	France
Azienda USL Toscana Sud Est	Arezzo	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hopital Saint Eloi	Montpellier	France
Clpi Dk Nllqm	Vandoeuvre Les Nancy	France
Hsbfmjao Uffuwgqrpcbfs Dbddwvgb	Donostia / San Sebastian	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	12.01.2024
Italy	Not recruiting	12.01.2024
Spain	Not recruiting	12.01.2024

Trial locations

Investigated drugs:

Durvalumab is a medication used in this trial to help the body’s immune system attack cancer cells. It is a type of immunotherapy that works by blocking a protein that stops the immune system from working properly, allowing it to better target and destroy cancer cells.

Bevacizumab is another medication used in this trial, which helps to prevent the growth of new blood vessels that tumors need to grow. By blocking these blood vessels, bevacizumab can help to slow down or stop the growth of cancer.

Transarterial Chemoembolization (TACE) is a procedure used in this trial 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. This helps to shrink the tumor and limit its growth.

Investigated diseases:

Hepatocellular carcinoma

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 is often associated with chronic liver diseases, such as cirrhosis or hepatitis. The disease progresses as the cancerous cells multiply and form tumors, which can disrupt liver function. Over time, these tumors may grow larger or spread to nearby tissues and organs. Symptoms can include abdominal pain, weight loss, and jaundice. The progression of the disease can vary, with some cases remaining stable for a period before advancing.

Trial ID:

2023-509053-32-00

Protocol code:

EMERALD-1

NCT ID:

NCT03778957

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Durvalumab and Bevacizumab with TACE in Patients with Localized Liver Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?