Spots Global Cancer Trial Database for The ABC-HCC Trial: Atezolizumab Plus Bevacizumab vs. Transarterial Chemoembolization (TACE) in Intermediate-stage HepatoCellular Carcinoma
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Trial Identification
Brief Title: The ABC-HCC Trial: Atezolizumab Plus Bevacizumab vs. Transarterial Chemoembolization (TACE) in Intermediate-stage HepatoCellular Carcinoma
Official Title: 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
Study ID: NCT04803994
Conditions
Study Description
Brief 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.
Detailed Description: The main purpose of this phase IIIb study is to test the efficacy and safety of atezolizumab in combination with bevacizumab compared to TACE in patients with intermediate stage liver cancer. Primary efficacy objective is to assess the efficacy of atezolizumab in combination with bevacizumab compared to TACE in patients with intermediate stage liver cancer. The secondary efficacy objective is to further characterize the responses obtained with the respective therapeutic strategy and to assess the impact of each therapeutic strategy on liver function over time. Furthermore the objective is to evaluate the safety and tolerability of each therapeutic strategy and their respective impact on Quality of Life and to identify prognostic and predictive angiogenic and immune related biomarkers (tissue and circulating) for study endpoints. This is a Phase IIIb, randomised, multicenter, open-label study. Approximately 434 patients suffering from intermediate-stage hepatocellular carcinoma will be enrolled in this trial. Patients will be recruited from up to 60 sites in 10 different countries.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
LKH - Univ. Klinikum Graz, Graz, , Austria
Medzinische Universität Innsbruck, Innsbruck, , Austria
Klinikum Klagenfurt am Wörthersee, Klagenfurt, , Austria
Ordensklinikum Linz, Linz, , Austria
Universitätsklinikum St. Pölten, St. Pölten, , Austria
Medizinische Universität Wien, Wien, , 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
Universitätsklinikum Dresden, Dresden, , Germany
Universitätsklinikum Düsseldorf, Düsseldorf, , Germany
Universitätsklinikum Erlangen, Erlangen, , Germany
Klinikum Esslingen, Esslingen, , Germany
Krankenhaus Nordwest, Frankfurt am Main, , Germany
Universitätsklinikum Frankfurt, Frankfurt, , Germany
Universitätsklinikum Freiburg, Freiburg, , Germany
Universitätsmedizin Göttingen, Göttingen, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Klinikum Konstanz, Konstanz, , Germany
Krankenhaus Maria-Hilf Krefeld, Krefeld, , Germany
Uniklinik Köln, Köln, , 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
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, Milano, , 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 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, Malaga, , Spain
Hospital Marqués de Valdecilla, Santander, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Contact Details
Name: Salah Eddin Al-Batran, Prof. Dr.
Affiliation: Institut für Klinische Krebsforschung IKF GmbH, Frankfurt, Germany
Role: STUDY_DIRECTOR
Name: Peter Galle, Prof. Dr.
Affiliation: Universitätsmedizin Mainz, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: Jordi Bruix, Prof. Dr.
Affiliation: Barcelona Clinic Liver Cancer, Universitat de Barcelona, Spain
Role: PRINCIPAL_INVESTIGATOR
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