Study on Atezolizumab and Bevacizumab for Patients with Small Hepatocellular Carcinoma Undergoing Radiofrequency 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 study involves the use of two medications, Atezolizumab and Bevacizumab. Atezolizumab is also known by the code name RO5541267, and Bevacizumab has several code names, including BI 695502 and PF-06439535. These medications are being tested in combination with a procedure called percutaneous radiofrequency ablation, which is a technique that uses heat to destroy cancer cells.

The purpose of the study is to compare how well patients do without the cancer coming back over a period of two years. Participants in the study will receive either the medications or a placebo, along with the radiofrequency ablation procedure. The study will follow a specific schedule where participants will receive treatments and undergo regular check-ups, including imaging tests like MRI (Magnetic Resonance Imaging), to monitor their health and the status of the cancer.

The study is designed to help understand if the combination of Atezolizumab and Bevacizumab with radiofrequency ablation can improve outcomes for patients with small HCC. Participants will be monitored closely for any signs of the cancer returning or spreading, and their overall health will be assessed throughout the study period.

1 initial treatment phase

The initial phase involves the administration of atezolizumab as a neoadjuvant treatment. This medication is given through an intravenous infusion. The specific dosage and frequency will be determined by the medical team based on individual patient needs.

2 radiofrequency ablation procedure

Following the initial treatment with atezolizumab, a procedure called percutaneous radiofrequency ablation is performed. This procedure targets small liver tumors, known as hepatocellular carcinoma (HCC), and is conducted by inserting a needle into the tumor to apply heat and destroy cancer cells.

3 adjuvant treatment phase

After the ablation procedure, the adjuvant treatment phase begins. This involves the administration of both atezolizumab and bevacizumab. These medications are given through intravenous infusions. The specific dosage and frequency will be determined by the medical team based on individual patient needs.

4 follow-up and monitoring

Patients will undergo regular follow-up and monitoring to assess recurrence-free survival. This includes magnetic resonance imaging (MRI) scans at 3, 6, 9, 12, 15, 18, 21, and 24 months after randomization. The scans will help detect any recurrence of cancer or the emergence of new nodules.

Who Can Join the Study?

Male or female patients who are 18 years of age or older.
Diagnosis of HCC (Hepatocellular carcinoma) based on imaging following specific guidelines.
Patients with HCC who are eligible for a treatment called ablation, as determined by a group of medical experts. This includes:
- All HCC nodules (small lumps) that are 3 cm or smaller.
- 1 to 3 nodules of HCC.
At least one measurable lesion (abnormal area) in the liver, as seen on an MRI scan, following specific criteria.
Liver function status must be Child-Pugh Class A, which is a way to measure how well the liver is working.
ECOG Performance Status of 0 or 1, which is a scale used to assess how a patient’s disease is affecting their daily living abilities.
Adequate bone marrow, liver, and kidney function, as shown by specific laboratory tests:
- Hemoglobin level greater than 8.5 g/dL.
- Absolute neutrophil count (a type of white blood cell) of 1500/mm³ or more.
- Platelet count of 50,000/mm³ or more.
- Total bilirubin (a substance made by the liver) of 2 mg/dL or less.
- ALT and AST (liver enzymes) levels that are 5 times the upper limit of normal or less.
- Serum creatinine (a waste product in the blood) level that is 1.5 times the upper limit of normal or less.
- Lipase (an enzyme) level that is 2 times the upper limit of normal or less.
- Prothrombin time (a blood clotting test) greater than 50%.
- Glomerular Filtration Rate (GFR, a test to check kidney function) of 35 mL/min/1.73 m² or more.
Life expectancy of 3 months or more.
Women who can have children and men must agree to use effective birth control methods.
Patients must be part of a Social Security System.

Who Cannot Join the Study?

Patients with any other type of cancer besides hepatocellular carcinoma cannot participate. Hepatocellular carcinoma is a type of liver cancer.
Patients who have had a recurrence of cancer within the last 2 years are not eligible. Recurrence means the cancer has come back after treatment.
Patients who are under 18 years old or over 65 years old cannot join the study.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients with severe liver disease, other than the cancer being studied, are excluded. Severe liver disease means the liver is not working well.
Patients who have had a liver transplant cannot take part in the study.
Patients who are currently participating in another clinical trial are not eligible.
Patients with a history of severe allergic reactions to any of the study medications are excluded. Severe allergic reactions can cause serious symptoms like difficulty breathing.
Patients with uncontrolled high blood pressure are not allowed to participate. Uncontrolled high blood pressure means it is not being managed well with treatment.
Patients with active infections that require treatment are excluded. Active infections mean infections that are currently causing symptoms and need medical care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier De Perpignan	Perpignan	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Saint Joseph	Marseille	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hopital Beaujon	Clichy	France
Cbkbbf Hlhmyitoacj Rfypbplj Dkraufllrtzyco	Angers	France
Cpyxfb Hwqhtzdxson Ulnolpcjboeaf Du Dfhwj	Dijon	France
Chxf Dj Nzvbt	Vandoeuvre Les Nancy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	23.02.2021

Trial locations

Investigated drugs:

Atezolizumab is a medication used in this trial to help the body’s immune system fight cancer cells. It is given to patients both before and after a procedure to remove liver tumors. The goal is to prevent the cancer from coming back.

Bevacizumab is another medication used in this trial. It works by stopping the growth of new blood vessels that tumors need to grow. It is given to patients after the procedure to help prevent the cancer from returning.

Percutaneous Radiofrequency Ablation is a procedure used in this trial to treat small liver tumors. It involves using heat to destroy cancer cells. This procedure is combined with the medications to improve the chances of stopping the cancer from coming back.

Investigated diseases:

Hepatocellular carcinoma

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, such as cirrhosis or hepatitis. The disease may initially present with symptoms like abdominal pain, weight loss, or jaundice. As it progresses, the cancer can grow and spread to other parts of the liver or to distant organs. The progression of the disease can lead to liver dysfunction and other complications. Monitoring typically involves imaging studies to track tumor growth and spread.

Trial ID:

2024-519113-59-00

NCT ID:

NCT04727307

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Atezolizumab and Bevacizumab for Patients with Small Hepatocellular Carcinoma Undergoing Radiofrequency Ablation

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