Study on Durvalumab and Tremelimumab for Liver Cancer Patients Undergoing Electroporation Ablation

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What is this study about?

This clinical trial is focused on studying a type of liver cancer known as Hepatocellular Carcinoma (HCC). The trial will explore the effects of two medications, Durvalumab and Tremelimumab, in patients who are undergoing a treatment called electroporation ablation, which aims to destroy cancer cells. Durvalumab is also known by its code name MEDI4736. The purpose of the study is to assess how well these medications work in preventing the cancer from coming back within a year after treatment.

Participants in the study will receive Durvalumab and Tremelimumab before their main cancer treatment, which is referred to as the neoadjuvant phase. After the main treatment, they will continue to receive Durvalumab in what is called the adjuvant phase. The medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The study will monitor the patients’ health and the cancer’s response to the treatment over time.

The trial will also look at various aspects of the treatment process, such as changes in the size and characteristics of the cancer nodules, the rate of cancer recurrence, and overall survival rates one year after the procedure. Additionally, the study will track any side effects related to the treatment and how well patients adhere to the treatment schedule. This research aims to provide valuable insights into the effectiveness of combining these medications with electroporation ablation for treating Hepatocellular Carcinoma.

1 initial visit and consent

Upon joining the study, you will attend an initial visit where the study details will be explained. You will be asked to provide written informed consent, confirming your understanding and willingness to participate.

During this visit, your eligibility will be confirmed through various tests, including blood tests and imaging scans, to ensure you meet the study criteria.

2 neoadjuvant treatment phase

You will begin the neoadjuvant treatment phase, which involves receiving two medications: durvalumab and tremelimumab. These medications are administered through an intravenous infusion, which means they are given directly into your bloodstream through a vein.

The specific dosage and frequency of these medications will be determined by the study protocol, and you will receive them over a set period before the main procedure.

3 imaging and assessment

After completing the neoadjuvant treatment, you will undergo imaging tests such as a CT scan or MRI. These tests will help assess changes in the tumor size and characteristics.

The results will be used to evaluate the effectiveness of the neoadjuvant treatment and to plan the next steps in your care.

4 electroporation ablation procedure

You will undergo an electroporation ablation procedure, which is a treatment aimed at destroying cancer cells in the liver. This procedure is performed with curative intent, meaning it aims to eliminate the cancer.

The procedure will be scheduled based on your specific medical condition and the results of the previous assessments.

5 adjuvant treatment phase

Following the ablation procedure, you will enter the adjuvant treatment phase. During this phase, you will receive durvalumab infusions to help prevent cancer recurrence.

The frequency and duration of these infusions will be determined by the study protocol, and you will continue to receive them for a specified period.

6 follow-up visits and monitoring

You will have regular follow-up visits to monitor your health and the effectiveness of the treatment. These visits will include physical examinations, blood tests, and imaging studies.

The primary goal is to assess your local recurrence-free survival at one year and to monitor for any potential side effects or complications from the treatment.

Who Can Join the Study?

Male or female patients who are 18 years of age or older.
Have a certain level of white blood cells called neutrophils (ANC ≥ 1.0 × 10⁹/L).
Have a certain level of platelets (≥ 75 × 10⁹/L), which are cells that help with blood clotting.
Have a serum bilirubin level ≤ 1.5 times the normal limit. Bilirubin is a substance made by the liver. This does not apply to patients with a condition called Gilbert’s syndrome.
Have AST (SGOT) and ALT (SGPT) levels ≤ 5 times the normal limit. These are enzymes that show how well the liver is working.
Have a creatinine clearance level > 40 mL/min, which shows how well the kidneys are working. This can be measured or calculated using a formula.
Be willing and able to follow the study rules, including attending treatment sessions and check-ups.
Have at least one tumor lesion that can be measured and has not been treated with radiation before. This must be checked by a CT or MRI scan within 28 days before joining the study.
If infected with HCV (Hepatitis C Virus), patients must be managed according to international guidelines.
If infected with HBV (Hepatitis B Virus), patients must receive antiviral therapy if needed.
Provide written informed consent to participate in the study.
Have a confirmed diagnosis of HCC (Hepatocellular Carcinoma) through tests.
Have newly diagnosed or recurrent HCC that meets specific size and number criteria, and be eligible for a procedure called IRE (Irreversible Electroporation).
Have adequate bone marrow, liver, and kidney function as shown by specific lab tests.
Have a life expectancy of at least 3 months.
Women who can have children must agree to use one effective method of contraception until 3 months after the last treatment and avoid pregnancy.
Be affiliated with a Social Security System.
Have a hemoglobin level ≥ 9.0 g/dL, which is a protein in red blood cells that carries oxygen.

Who Cannot Join the Study?

Patients with any other type of cancer besides hepatocellular carcinoma (a type of liver cancer) cannot participate.
Patients who have had another cancer within the last 5 years, except for certain skin cancers or in situ cervical cancer, are excluded.
Patients with severe heart disease or uncontrolled high blood pressure are not eligible.
Patients with active infections, including hepatitis B, hepatitis C, or HIV, cannot join the study.
Patients who have had an organ transplant are excluded.
Patients with autoimmune diseases, which are conditions where the immune system attacks the body, are not eligible.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial are excluded.
Patients with a history of severe allergic reactions to similar drugs are not eligible.
Patients with any other serious medical condition that might interfere with the 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
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Cbpjtp Hoqmdmqkzht Rbnvznkp Ddfzpvlxyrhrpz	Angers	France
Hwjmgqty Usgxtvoixmnkmq Sxfjmowwsx &hknreu Hyxrayf di Hfsrdlfcspq	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	28.03.2024

Trial locations

Investigated drugs:

Durvalumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, Durvalumab is used both before and after a procedure called electroporation ablation, which aims to destroy liver cancer cells. The goal is to see if Durvalumab can help prevent the cancer from coming back after treatment.

Tremelimumab is another immunotherapy medication. It helps your immune system fight cancer by blocking a specific protein that usually stops the immune system from attacking cancer cells. In this trial, Tremelimumab is used before the electroporation ablation procedure to see if it can help improve the effectiveness of the treatment in preventing the cancer from returning.

Hepatocellular carcinoma – Hepatocellular carcinoma is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It often develops in the context of chronic liver disease, particularly in individuals with cirrhosis due to hepatitis B, hepatitis C, or alcohol consumption. The disease typically progresses through stages, starting with small nodules that can grow and spread within the liver. As the cancer advances, it may invade blood vessels and spread to other parts of the body. Symptoms may include abdominal pain, weight loss, and jaundice, although they often appear only in later stages. The progression of the disease can vary, with some tumors growing slowly and others more rapidly.

Trial ID:

2024-515768-30-01

Protocol code:

APHP220729

NCT ID:

NCT06045975

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Durvalumab and Tremelimumab for Liver Cancer Patients Undergoing Electroporation Ablation

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