RecruitingPhase 3NCT04803994

The ABC-HCC Trial: Atezolizumab Plus Bevacizumab vs. Transarterial Chemoembolization (TACE) in Intermediate-stage HepatoCellular Carcinoma

The ABC-HCC Trial: A Phase IIIb, Randomized, Multicenter, Open-label Trial of Atezolizumab Plus Bevacizumab Versus Transarterial Chemoembolization (TACE) in Intermediate-stage HepatoCellular Carcinoma

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Enrollment

434 participants

Start Date

Jul 6, 2021

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma

Summary

The ABC-HCC trial is a Phase IIIb, randomised, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab plus bevacizumab versus TACE in patients with intermediate-stage HCC. Approximately 434 patients in two arms of treatment will be enrolled.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for intermediate-stage liver cancer (hepatocellular carcinoma): a newer immunotherapy combination (atezolizumab plus bevacizumab) versus a standard procedure that delivers chemotherapy directly to liver tumors through the blood vessels (TACE), to see which works better. **You may be eligible if...** - You are 18 or older - You have confirmed liver cancer (hepatocellular carcinoma) at an intermediate stage - You have reasonably preserved liver function - You are in good enough health to receive treatment - Your cancer has not spread outside the liver **You may NOT be eligible if...** - You have previously received systemic therapy for liver cancer - Your liver function is severely impaired - Your cancer has spread beyond the liver - You have conditions incompatible with the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab

1200 mg atezolizumab intravenously Q3W (max 32 cycles, up to 24 months)

DRUGBevacizumab

15 mg/kg intravenously Q3W (max 32 cycles, up to 24 months)

PROCEDURETACE

Locoregional therapy will be performed as a standard-of-care procedure

Locations(72)

LKH - Univ. Klinikum Graz

Graz, Austria

Medzinische Universität Innsbruck

Innsbruck, Austria

Klinikum Klagenfurt am Wörthersee

Klagenfurt, Austria

Ordensklinikum Linz

Linz, Austria

Universitätsklinikum St. Pölten

Sankt Pölten, Austria

Medizinische Universität Wien

Vienna, Austria

Institut Sainte-Catherine

Avignon, France

Hôpital Jean-Verdier Avicenne

Bobigny, France

CHU Bordeaux

Bordeaux, France

CHU Clermont-Ferrand CHU Estaing

Clermont-Ferrand, France

Beaujon Hospital

Clichy, France

CHU Grenoble

Grenoble, France

Croix-Rousse Hopital

Lyon, France

Saint Joseph Hopital - Marseille

Marseille, France

Hôpital Universitaire Pitié Salpêtrière

Paris, France

Centre Hépato-biliaire Paul Brousse

Villejuif, France

University Hospital RWTH Aachen

Aachen, Germany

Klinikum St. Marien Amberg

Amberg, Germany

Vivantes Klinikum Neukölln

Berlin, Germany

Universitätsklinikum Bochum

Bochum, Germany

Uniklinik Köln

Cologne, Germany

Universitätsklinikum Dresden

Dresden, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Universitätsklinikum Erlangen

Erlangen, Germany

Klinikum Esslingen

Esslingen am Neckar, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Krankenhaus Nordwest

Frankfurt am Main, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitätsmedizin Göttingen

Göttingen, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Klinikum Konstanz

Konstanz, Germany

Krankenhaus Maria-Hilf Krefeld

Krefeld, Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, Germany

Universitätsmedizin Mainz

Mainz, Germany

Universitätsklinikum Mannheim

Mannheim, Germany

Universitätsklinikum Marburg

Marburg, Germany

Klinikum rechts der Isar München

München, Germany

Klinikum Mutterhaus Trier

Trier, Germany

Krankenhaus der Barmherzigen Brüder Trier

Trier, Germany

Uniklinik Ulm

Ulm, Germany

St. Josefs Hospital Wiesbaden

Wiesbaden, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

Policlinico S. Orsola Bologna

Bologna, Italy

Instituto Tumori della Romagna IRST IRCCS

Meldola, Italy

Policlinico di Milano

Milan, Italy

Instituto di Tumori

Milan, Italy

Università di Pisa (UNIPI)

Pisa, Italy

AOUI Verona

Verona, Italy

Hokkaido University Hospital

Hokkaido, Japan

Kobe University Hospital

Kobe, Japan

Kumamoto University Hospital

Kumamoto, Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Japan

Nagasaki University Hospital

Nagasaki, Japan

Kindai University Hospital

Osaka, Japan

Saitama Medical University Hospital

Saitama, Japan

Fujita Health University Hospital

Toyoake, Japan

Yamaguchi University Hospital

Ube, Japan

Hospital Universitario de Alicante

Alicante, Spain

Hospital Infanta Cristina

Badajoz, Spain

Hospital Germans Trias I Pujol

Badalona, Spain

Hospital Universitari Vall d'Hebrón

Barcelona, Spain

Barcelona Clinic Liver Cancer, Universitat de Bracelona

Barcelona, Spain

Hospital Puerta del Mar

Cadiz, Spain

Hospital de Jaen

Jaén, Spain

Hospital Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Fundación Jimenez Diaz

Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, Spain

Hospital de Alcorcón

Madrid, Spain

Hospital de Málaga

Málaga, Spain

Hospital Marqués de Valdecilla

Santander, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

View Full Details on ClinicalTrials.gov

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