Study on Atezolizumab and Bevacizumab for Patients with Unresectable Liver Cancer

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What is this study about?

This clinical trial is focused on studying a type of liver cancer called unresectable hepatocellular carcinoma, which means the cancer cannot be removed with surgery. The study is testing the effectiveness of two medications, atezolizumab and bevacizumab, which are given together. Atezolizumab is also known by its code name, RO5541267. These medications are administered through a process called infusion, where the medicine is slowly introduced into the bloodstream through a vein.

The purpose of the study is to evaluate how well these medications work when used alone or in combination with a procedure called transarterial chemoembolization (TACE). TACE is a treatment that delivers chemotherapy directly to the liver tumor while blocking the blood supply to the tumor, which can help shrink it. The study will compare two approaches: starting with atezolizumab and bevacizumab and adding TACE if the disease progresses, or starting with all treatments at once.

Participants in the study will receive the treatments over a period of up to 24 months. The study will monitor the response of the cancer to the treatments, as well as the overall health and quality of life of the participants. The goal is to determine the best way to use these treatments to manage liver cancer that cannot be surgically removed.

1 initial treatment phase

Upon joining the study, the treatment begins with the administration of two medications: atezolizumab and bevacizumab. These medications are given as a solution through a vein, known as an intravenous infusion.

The dosage for atezolizumab is 1,200 mg, and for bevacizumab, it is 25 mg/ml. The frequency and duration of these infusions will be determined by the study protocol and the healthcare team overseeing the trial.

2 monitoring and assessment

Throughout the trial, regular monitoring and assessments are conducted to evaluate the response to the treatment. This includes various tests and imaging studies to check the progress of the disease.

The healthcare team will assess the effectiveness of the treatment and any side effects experienced. Adjustments to the treatment plan may be made based on these assessments.

3 on-demand selective tace

If there is any progression of the disease, an additional procedure called selective transarterial chemoembolization (sdTACE) may be performed. This procedure targets the liver tumor directly with chemotherapy and blocks its blood supply.

The decision to perform sdTACE will be based on the results of the monitoring and assessment phase.

4 follow-up and conclusion

After completing the treatment phases, follow-up visits will be scheduled to monitor long-term effects and overall health. These visits help in understanding the overall impact of the treatment on the disease.

The trial is expected to continue until the end of 2027, with regular updates provided to participants about their health status and any new findings from the study.

Who Can Join the Study?

Signed informed consent from the patient.
Age of 18 years or older at the time of signing the consent form.
Ability to follow the study protocol, as judged by the study doctor.
Life expectancy of at least 12 weeks.
Diagnosis of hepatocellular carcinoma (HCC), confirmed by a tissue sample or specific imaging tests.
The disease cannot be treated with surgery or local treatments but is suitable for a procedure called transarterial chemoembolization (TACE), with less than 50% of the liver affected by the tumor.
At least one tumor that can be measured and has not been treated yet.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which means the patient is fully active or has some symptoms but does not need bed rest during the day.
Child-Pugh class A or B7, which is a score that assesses liver function.
Adequate blood and organ function based on specific lab tests, including:
- White blood cell count, platelet count, and hemoglobin levels within certain limits.
- Liver enzymes and bilirubin levels not too high.
- Kidney function within acceptable range.
- Low levels of protein in urine.
Negative test for HIV at screening.
Documented status of hepatitis infection, with specific requirements for those with active hepatitis B.
For women who can become pregnant: a negative pregnancy test and agreement to use effective birth control methods or remain abstinent during the study and for a period after.
For men: agreement to use birth control methods or remain abstinent and not donate sperm during the study and for a period after.

Who Cannot Join the Study?

Patients with non-resectable hepatocellular carcinoma (HCC) cannot participate. This means the liver cancer cannot be removed by surgery.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who do not meet other specific health criteria set by the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Klinikum Nuernberg	Nürnberg	Germany
Klinikum Esslingen GmbH	Esslingen Am Neckar	Germany
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Universitaetsklinikum Magdeburg AöR	Magdeburg	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Ludwig Maximilian University Of Munich	Munich	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Uxxkbrfphw Mwsupbv Cqtbjf Hjapcjuzsxampcrnh	Hamburg	Germany
Uugkzbebym Hfromnpt Cobxqta	Cologne	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	10.06.2020

Trial locations

Investigated drugs:

Atezolizumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, atezolizumab is used to treat patients with liver cancer that cannot be removed by surgery. The goal is to see if it can help control the cancer and improve the patient’s response to treatment.

Bevacizumab is a medication that targets the blood vessels that supply nutrients to tumors. By blocking these blood vessels, bevacizumab can help slow down or stop the growth of cancer. In this study, it is used alongside atezolizumab to see if the combination can be more effective in treating liver cancer.

Transarterial Chemoembolization (TACE) is a procedure used 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. In this trial, TACE is used either after treatment with atezolizumab and bevacizumab or at the same time as these medications, to see which approach works better for patients with liver cancer.

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 progresses as the cancerous cells multiply and form a tumor, which can grow and spread to other parts of the liver and beyond. As the tumor enlarges, it may disrupt liver function and lead to symptoms such as abdominal pain, weight loss, and jaundice. Over time, the cancer can invade blood vessels and metastasize to other organs. The progression of hepatocellular carcinoma can vary, with some tumors growing slowly and others advancing more rapidly.

Trial ID:

2024-512682-14-00

Protocol code:

AIO-HEP-0418-DEMAND

NCT ID:

NCT04224636

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Atezolizumab and Bevacizumab for Patients with Unresectable Liver Cancer

What is this study about?

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