Study on the Safety of Atezolizumab and Bevacizumab for Liver Transplant Patients with Advanced Liver Cancer

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What is this study about?

This clinical trial is focused on studying the safety of a treatment combination for patients who have undergone a liver transplant and are now facing advanced liver cancer, known as hepatocellular carcinoma. The treatment being tested includes two medications: atezolizumab and bevacizumab. These medications are given as a solution through an infusion into the vein, which means they are administered directly into the bloodstream.

The purpose of the study is to evaluate how safe this combination of medications is for patients who have had a liver transplant and are dealing with a return of liver cancer. The study will observe patients over a period of six months to see how their bodies respond to the treatment. During this time, the patients will also receive a standard treatment to help prevent their bodies from rejecting the transplanted liver. The study aims to ensure that the treatment does not cause any harmful effects on the liver or the overall health of the patients.

Throughout the study, patients will be monitored regularly to check for any side effects or changes in their condition. This will include regular imaging tests, like CT scans, to track the progress of the cancer and assess the overall health of the patients. The study will also look at how long patients live without the cancer getting worse and how the treatment affects their quality of life. The goal is to gather information that can help improve treatment options for patients with advanced liver cancer who have had a liver transplant.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and previous medical history.

Participants must have undergone a liver transplant more than six months ago and have a diagnosis of advanced liver cancer that cannot be treated with surgery or local therapies.

2 treatment initiation

The treatment involves two medications: atezolizumab and bevacizumab, both administered through an intravenous (IV) infusion.

The specific dosage and frequency of administration are determined by the medical team based on individual health conditions.

3 treatment duration

The treatment is planned to continue for a period of up to 24 months, with regular assessments to monitor the response and any side effects.

Participants are required to attend regular appointments for imaging tests, such as CT scans, every three months to evaluate the progression of the disease.

4 safety and monitoring

Safety is a primary concern, and the study aims to assess the rate of acute cellular rejection (ACR) at six months.

Participants will be monitored for any adverse effects, and their quality of life will be evaluated regularly using a standardized questionnaire.

5 end of treatment

The study is expected to conclude by December 2028, with the final assessments of treatment effectiveness and safety.

Participants will have a final evaluation to determine the overall outcome of the treatment and any long-term effects.

Who Can Join the Study?

Patients must be between 18 and 90 years old.
Patients must have had a liver transplant more than 6 months ago.
Patients must have an ECOG Performance Status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest.
Women who can have children and men must agree to use effective birth control during treatment and for a certain time after treatment ends: 5 months for atezolizumab and 6 months for bevacizumab.
Patients must have a Child-Pugh class A liver function, indicating good liver function.
Patients must have a diagnosis of HCC recurrence according to specific medical criteria.
Patients must have advanced HCC that cannot be treated with surgery or local treatments.
Patients must have at least one measurable untreated tumor.
The treatment plan with Atezo-Beva must be proposed as the first option in a meeting with multiple specialists.
Patients must have adequate blood and organ function, shown by specific lab test results:

ANC (a type of white blood cell) must be at least 1.5 x 10⁹/L without support.
Lymphocyte count must be at least 0.5 x 10⁹/L.
Platelet count must be at least 75 x 10⁹/L without transfusion.
Hemoglobin must be at least 90 g/L. Patients can receive a transfusion to meet this level.
AST and ALT (liver enzymes) must be no more than 5 times the normal limit.
Serum bilirubin must be no more than 3 times the normal limit.
Creatinine clearance must be at least 40 mL/min, which measures kidney function.
For patients not on blood thinners, INR or aPTT (blood clotting tests) must be no more than 2 times the normal limit.
Urine dipstick for protein must show less than 2+ protein. If more, a 24-hour urine test must show less than 1 gram of protein.

Who Cannot Join the Study?

Patients who have not had a liver transplant. A liver transplant is a surgery to replace a diseased liver with a healthy one from another person.
Patients who do not have advanced hepatocellular carcinoma. This is a type of liver cancer that has progressed to a more serious stage.
Patients who are not receiving a standardized immunosuppressive treatment. This treatment helps prevent the body from rejecting the new liver after a transplant.
Patients who are not experiencing a recurrence of hepatocellular carcinoma after a liver transplant. Recurrence means the cancer has come back after treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Hospital Paul Brousse	Villejuif	France
Cznwxb Hjymruwaeps Rxggzgkp Uurfleqepyyxb Do Tflqu	Tours	France
Cbp Cvxyi Rpeiqhjrcip	Lyon	France
Hwpylfgv Uhyfqgbnnrimii Ssuegqjhjz &zqxmiz Hirlrtz dt Hetcswlzecd	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	02.12.2024

Trial locations

Investigated drugs:

Atezolizumab is a medication used to help the immune system fight cancer cells. It works by blocking a protein that stops the immune system from attacking cancer cells, allowing the body to better target and destroy them.

Bevacizumab is a medication that helps prevent the growth of new blood vessels that tumors need to grow. By blocking these blood vessels, it can help slow down or stop the growth of cancer.

The trial is studying the combination of these two medications in patients who have had a liver transplant and are experiencing a return of liver cancer. The goal is to see if this combination is safe for these patients while they are also receiving standard treatments to prevent their body from rejecting the transplanted liver.

Investigated diseases:

Hepatocellular Carcinoma – This 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 body, potentially affecting liver function. In advanced stages, it may lead to complications such as liver failure or metastasis to other organs.

Trial ID:

2024-514400-14-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety of Atezolizumab and Bevacizumab for Liver Transplant Patients with Advanced Liver Cancer

What is this study about?

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