Study of Atezolizumab, Bevacizumab, and Tiragolumab for Patients with Untreated Advanced or Metastatic Liver Cancer

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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 is evaluating the effectiveness of a combination of medications, including Atezolizumab, Bevacizumab, and Tiragolumab. Atezolizumab and Bevacizumab are already used in treating certain cancers, while Tiragolumab is being tested for its potential benefits. Some participants will receive a placebo instead of Tiragolumab to help researchers understand the effects of the actual medication.

The purpose of the study is to assess how well these medications work together in patients who have not yet received treatment for their advanced or spreading liver cancer. Participants will receive the medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will compare the outcomes of those receiving the full combination of medications to those receiving only Atezolizumab and Bevacizumab, with or without Tiragolumab.

Throughout the study, participants will be monitored to see how their cancer responds to the treatment and to track their overall health. The study aims to determine if the combination of these medications can help control the cancer and improve survival rates. The trial will continue for a set period, during which participants will have regular check-ups and assessments to ensure their safety and to gather important data on the treatment’s effectiveness.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including the diagnosis of hepatocellular carcinoma (HCC) and other health assessments.

Participants must have no prior systemic treatment for HCC and meet other health and virology status requirements.

2 randomization

Participants are randomly assigned to receive either the combination of atezolizumab, bevacizumab, and tiragolumab or atezolizumab and bevacizumab alone.

This process is double-blind, meaning neither the participants nor the researchers know which treatment is being administered.

3 treatment administration

The medications are administered through intravenous infusion. Atezolizumab is given as a 1,200 mg solution, and bevacizumab is provided as a 25 mg/ml concentrate.

Tiragolumab, if included in the treatment, is also administered via infusion. The frequency and duration of these infusions are determined by the study protocol.

4 monitoring and assessments

Participants undergo regular monitoring to assess the progression of the disease and overall health status.

This includes evaluating progression-free survival (PFS) and overall survival (OS), as well as other health indicators.

5 follow-up

Participants continue to be monitored for any adverse effects and the effectiveness of the treatment.

The study aims to collect data on the incidence and severity of any side effects, as well as the presence of anti-drug antibodies.

6 completion of the study

The study is estimated to conclude by September 2026, with ongoing assessments and data collection until that time.

Final evaluations will be conducted to determine the overall outcomes and effectiveness of the treatments.

Who Can Join the Study?

The patient must have Hepatocellular Carcinoma (HCC), which is a type of liver cancer.
The cancer must be locally advanced (spread within the liver) or metastatic (spread to other parts of the body) and/or unresectable (cannot be removed by surgery). The diagnosis should be confirmed by a tissue sample or specific clinical criteria for liver disease.
The patient should not have received any previous systemic treatment (treatment that affects the whole body) for their advanced or metastatic liver cancer.
The patient must have a measurable disease, meaning there is at least one tumor that can be measured to see if it changes in size during the study.
The patient should have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
The patient must be Child-Pugh Class A, indicating good liver function.
The patient should have adequate hematologic and end-organ function, meaning their blood and organs are working well enough to participate in the study.
The patient must have a negative HIV test at the start of the study.
The patient must have documented hepatitis status, confirmed by tests for hepatitis B and C viruses.
Both male and female patients must agree to use specific methods of contraception during the study.

Who Cannot Join the Study?

Patients with other types of cancer besides Hepatocellular Carcinoma (HCC) cannot participate. HCC is a type of liver cancer.
Patients who have had a different cancer treatment recently may not be eligible.
Patients with severe heart problems or uncontrolled high blood pressure may be excluded.
Patients with serious infections or immune system issues might not be able to join.
Pregnant or breastfeeding women are not allowed to participate.
Patients with a history of severe allergic reactions to similar medications may be excluded.
Patients who are unable to follow the study procedures or attend regular check-ups might not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Clinico San Carlos	Madrid	Spain
Centre Hospitalier Universitaire De Lille	Lille	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario De Navarra	Pamplona	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hospital Universitario Central De Asturias	Oviedo	Spain
Hopital Saint Antoine	Paris	France
ID Clinic	Myslowice	Poland
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Universitaetsklinikum Magdeburg AöR	Magdeburg	Germany
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Hopital Saint Joseph	Marseille	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Hospital Universitario De Jaen	Jaen	Spain
Klinikum Esslingen GmbH	Esslingen Am Neckar	Germany
Hospital Clinico Universitario De Valencia	Valencia	Spain
Pia Fondazione Di Culto E Religione Card G Panico	Tricase	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Centre Hospitalier Universitaire De Nantes	Nantes	France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Area De Salud De Burgos Y Soria	Burgos	Spain
Hospital Paul Brousse	Villejuif	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Ctnfgnijk Umlayqezvrajys Ssruwzett	Woluwe-Saint-Lambert	Belgium
Cdqu Dw Nxshm	Vandoeuvre Les Nancy	France
Csygrhprgz Pfqmdns Lektnwyuz Scq z ohla	Gdansk	Poland
Cuiuij Hltwwuiexui Uealjwxqalabh Rjmdf	Reims	France
Iumrowpf Czjhrq Dnmopbnzpnkdwiwya	L'hospitalet De Llobregat	Spain
Cqkrxr Hhacnblpotk Vlhbist	Valence	France
Csoszro Urhgcfczmml Ds Nbuiclp	Madrid	Spain
Ckfrmu Hfqhdpfddzx Ew Uttdyzdbfqvba Dd Lhqriij	Limoges	France
Ukgmkmgqkn Od Akqaabq	Edegem	Belgium
Hwjxbrwg Vnme dcningct	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.08.2023
France	Not recruiting	01.08.2023
Germany	Not recruiting	01.08.2023
Italy	Not recruiting	01.08.2023
Poland	Not recruiting	01.08.2023
Spain	Not recruiting	01.08.2023

Trial locations

Investigated drugs:

Atezolizumab is a medication used in this trial to help the body’s immune system attack cancer cells. It works by blocking a protein that stops the immune system from working properly, allowing it to better target and destroy cancer cells.

Bevacizumab is another medication used in the trial. It works by blocking the growth of new blood vessels that tumors need to grow and spread. By cutting off the blood supply, it helps to slow down or stop the growth of the cancer.

Tiragolumab is an investigational medication being tested in this trial. It is designed to enhance the immune system’s ability to fight cancer by targeting a specific protein that can suppress immune responses. This may help the immune system to better recognize and attack cancer cells.

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 B and C infections. The disease may initially present with symptoms like abdominal pain, weight loss, or jaundice. As it progresses, the tumor can grow and spread to other parts of the liver or beyond. The progression of the disease can lead to liver dysfunction and complications related to tumor growth. Early detection is challenging, and the disease is often diagnosed at an advanced stage.

Trial ID:

2023-503422-39-00

Protocol code:

CO44668

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Atezolizumab, Bevacizumab, and Tiragolumab for Patients with Untreated Advanced or Metastatic Liver Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?