Study on the Effectiveness and Safety of Bevacizumab, Atezolizumab, and RO7247669 in Patients with Resectable Liver Cancer

1 1 1 1

What is this study about?

This clinical trial is focused on studying the effects of a treatment for Hepatocellular Carcinoma, a type of liver cancer. The study will explore the use of different combinations of immunotherapy drugs, which are treatments that help the body’s immune system fight cancer. The medications being tested include Avastin (bevacizumab), Tecentriq (atezolizumab), Tiragolumab, and a drug with the code name RO7247669. These drugs are given as a solution through an intravenous (IV) infusion, which means they are administered directly into the bloodstream.

The purpose of the study is to evaluate how effective these immunotherapy combinations are in treating patients with liver cancer that can be surgically removed. Participants in the study will receive one of the treatment combinations before their surgery. The study will monitor the response of the cancer to the treatment and any side effects that may occur. The goal is to see if these treatments can improve the chances of successful surgery and recovery.

Throughout the study, participants will be closely observed by medical professionals to ensure their safety and to gather information on how well the treatments work. The study will continue for several years, allowing researchers to collect comprehensive data on the effectiveness and safety of these immunotherapy combinations for treating Hepatocellular Carcinoma.

1 joining the study

Upon joining the study, the diagnosis of hepatocellular carcinoma (HCC) must be confirmed either through a biopsy or clinical criteria. The cancer should be operable with the intent to cure, as determined by the medical team.

The patient must have a measurable tumor and a performance status indicating they are well enough to participate. No previous treatments for HCC should have been administered.

2 treatment phase

The treatment involves a combination of immunotherapy drugs administered through intravenous infusion. The medications include bevacizumab, ro7247669, atezolizumab, and tiragolumab. Each drug is given as a solution for infusion.

The specific dosage and frequency of administration will be determined by the study protocol and the medical team overseeing the treatment.

3 surgical evaluation

After the treatment phase, the patient will be evaluated to determine if the cancer can be surgically removed. The goal is to achieve an R0 resection, meaning no cancer cells are left behind.

The evaluation will include imaging tests and assessments by the surgical team.

4 surgery

If the evaluation is favorable, surgery will be scheduled to remove the tumor. The timing and extent of the surgery will depend on the response to the treatment and the patient’s overall health.

The surgical team will aim to minimize complications and ensure a successful recovery.

5 post-operative care

Following surgery, the patient will receive care to monitor for any complications and to support recovery. This may include hospital stays, follow-up visits, and additional treatments if necessary.

The patient’s progress will be tracked to assess the long-term outcomes of the treatment and surgery.

Who Can Join the Study?

The patient must have a confirmed diagnosis of Hepatocellular Carcinoma (HCC), which is a type of liver cancer. This can be confirmed either by a tissue sample (histologically) or by clinical criteria set by the American Association for the Study of Liver Diseases (AASLD) for patients with liver scarring (cirrhosis).
The patient’s HCC must be suitable for a type of surgery called R0 surgical resection, which aims to remove all cancer with the intent to cure, as determined by the doctors involved in the patient’s care.
The patient must have a measurable disease, meaning there is at least one tumor that can be measured, according to specific guidelines called Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
The patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. This is a scale used to assess how well a patient can perform daily activities, with 0 meaning fully active and 1 meaning some restrictions but still able to do light work.
The patient must be classified as Child-Pugh Class A, which is a score used to assess the severity of liver disease, indicating the liver is functioning well.
The patient must not have received any previous local or whole-body treatment for HCC.

Who Cannot Join the Study?

Patients with other types of cancer besides Hepatocellular Carcinoma (a type of liver cancer) cannot participate.
Patients who have received certain treatments that might interfere with the study cannot participate.
Patients with severe or uncontrolled medical conditions that could affect their safety or the study results cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of allergic reactions to the study drugs cannot participate.
Patients who are unable to follow the study procedures or attend the required visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Vienna	Vienna	Austria
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Klinik Favoriten	Vienna	Austria
Landeskrankenanstalten-Betriebsgesellschaft Kabeg	Klagenfurt am Wörthersee	Austria
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Paul Brousse	Villejuif	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Gmqurg Upkfeyeqej Fcwavxfux	Frankfurt	Germany
Umuyufkmszjxgxsuysnpq Eloex Amx	Essen	Germany
Huskuiwk Uxltkfcdxstrj Mopqlgv Dg Vbfugyyfhk	Santander	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	31.12.2023
France	Not recruiting	31.12.2023
Germany	Not recruiting	31.12.2023
Spain	Not recruiting	31.12.2023

Trial locations

Investigated drugs:

Atezolizumab is an immunotherapy medication used in this trial. It works by helping the immune system recognize and attack cancer cells more effectively. It is often used in combination with other treatments to enhance its effectiveness against cancer.

Bevacizumab is another medication involved in the trial. It is designed to slow the growth of new blood vessels that tumors need to grow and spread. By blocking these blood vessels, bevacizumab can help to starve the tumor of nutrients and slow its growth.

Tiragolumab is an investigational drug being studied in this trial. It is a type of immunotherapy that targets specific proteins on cancer cells, helping the immune system to better identify and destroy these cells.

Cabozantinib is a medication that targets multiple pathways involved in cancer cell growth and spread. It is used to inhibit the growth of cancer cells and reduce the size of tumors.

Ipilimumab is an immunotherapy drug that works by activating the immune system to attack cancer cells. It is often used in combination with other immunotherapies to improve the body’s ability to fight 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 typically progresses by forming a mass in the liver, which can grow and spread to other parts of the body. As the tumor enlarges, it may cause symptoms like abdominal pain, weight loss, and jaundice. The progression of the disease can lead to liver dysfunction and complications related to the tumor’s growth. Early stages may not present noticeable symptoms, making regular monitoring crucial for those at risk.

Trial ID:

2022-502840-11-00

Protocol code:

GO44457

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Effectiveness and Safety of Bevacizumab, Atezolizumab, and RO7247669 in Patients with Resectable Liver Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?