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Brief Title: A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab
Official Title: A Phase III, Open-Label, Randomized Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab
Study ID: NCT04770896
Brief Summary: This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medizinische Universität Innsbruck; Universitätsklinik für Innere Medizin I, Innsbruck, , Austria
Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU, Salzburg, , Austria
Universitätsklinikum St. Pölten; Innere Medizin 2, St. Pölten, , Austria
Klinik Favoriten; Abteilung für Chirurgie, Wien, , Austria
Imeldaziekenhuis, Bonheiden, , Belgium
AZ KLINA, Brasschaat, , Belgium
Hospital Erasme, Bruxelles, , Belgium
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
UZ Gent, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
AZ Delta (Campus Rumbeke), Roeselare, , Belgium
Hospital Sao Rafael - HSR, Salvador, BA, Brazil
Sociedade beneficente de senhoras Hospital Sirio Libanes, Brasilia, DF, Brazil
Hospital Felicio Rocho, Belo Horizonte, MG, Brazil
Clinicas Oncologicas Integradas - COI, Rio De Janeiro, RJ, Brazil
Hospital Moinhos de Vento, Porto Alegre, RS, Brazil
Hospital Sao Lucas - PUCRS, Porto Alegre, RS, Brazil
YNOVA Pesquisa Clinica, Florianopolis, SC, Brazil
Centro Paulista de Oncologia, Sao Paulo, SP, Brazil
Beneficencia Portuguesa de Sao Paulo, São Paulo, SP, Brazil
Multiprofile Hospital for Active Treatment Uni Hospital; Department of medicinal oncology, Panagyurishte, , Bulgaria
Complex Oncological Center - Plovdiv, EOOD; Second Internal Department, Plovdiv, , Bulgaria
MHAT Sveta Sofia; Department of medical oncology, Sofia, , Bulgaria
MHAT SofiaMed; OOD, Sofia, , Bulgaria
SHATOD Dr. Marko Antonov Markov-Varna, EOOD; Department of Medicinall Onchotherapy and Palliative, Varna, , Bulgaria
Tom Baker Cancer Centre-Calgary, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Centro de Estudios Clínicos SAGA, Santiago, , Chile
Hospital Clinico de La Universidad de Chile J.J.A.; Oncologia, Santiago, , Chile
Pontificia Universidad Catolica de Chile; Clinica San Carlos de Apoquindo, Santiago, , Chile
The Fifth Medical Center of People's Liberation Army General Hospital, Beijing City, , China
Peking University People's Hospital, Beijing, , China
Hunan Cancer Hospital, Changsha CITY, , China
West China Hospital - Sichuan University, Chengdu City, , China
Sichuan Provincial Cancer Hospital, Chengdu, , China
Fujian Provincial Hospital, Fuzhou City, , China
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou City, , China
Sun Yet-sen University Cancer Center, Guangzhou City, , China
Nanfang Hospital, Southern Medical University, Guangzhou, , China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou City, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Anhui Province Cancer Hospital, Hefei City, , China
Shandong Provincial Hospital, Jinan, , China
Shandong Cancer Hospital, Jinan, , China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University), Nanjing City, , China
Zhongshan Hospital Fudan University, Shanghai, , China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, , China
Shengjing Hospital of China Medical University, ShenYang, , China
Tianjin Cancer Hospital, Tianjin, , China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan City, , China
Clinica CIMCA, San José, , Costa Rica
ICIMED Instituto de Investigación en Ciencias Médicas, San José, , Costa Rica
Clinical Hospital Centre Zagreb, Zagreb, , Croatia
AirForce Specialized Hospital; Clinical Oncology, Cairo, , Egypt
North Estonia Medical Centre, Oncology and hematology Clinic; Department of Chemotherapy, Tallinn, , Estonia
Tartu University Hospital; Clinic of Hematology and Oncology, Tartu, , Estonia
Docrates Cance Center; Docrates, Helsinki, , Finland
TAYS Radius rakennus; onkologinen lääketutkimusyksikkö, Tampere, , Finland
Turku Uni Central Hospital; Oncology Clinics, Turku, , Finland
CHU Grenoble Sud; Service hépato-gastroentérologie, GRENOBLE Cedex 9, , France
CHRU de Lille - Hopital Claude Huriez, Lille, , France
Aphm; Cpcet, Marseille, , France
CH Saint Eloi, Montpellier, , France
CHU de Nantes - Hotel Dieu, Nantes, , France
CHU Nice - Hôpital de l'Archet 2; service Hepato gastro enterologie, Nice Cedex, , France
APHP - Hopital Saint Antoine, Paris, , France
CHU Bordeaux, Pessac, , France
Centre Eugene Marquis; Service d'oncologie; Direction de la Recherche Clinique, Rennes, , France
CHU de Toulouse - Hôpital Rangueil, Toulouse Cedex 09, , France
Hopitaux de Brabois - Gastro-Entereologie, Vandoeuvre-les-nancy, , France
Hopital Paul Brousse; Centre Hepatologie Biliaire, Villejuif, , France
Klinikum Esslingen; Allg. Innere Med., Onkologie, Hämatologie, Gastroenterologie und Infektiologie, Esslingen, , Germany
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I, Frankfurt, , Germany
Med. Hochschule Hannover; Gastroenterologie, Hannover, , Germany
Uniklinik Mainz; I. Medizinische Klinik, Mainz, , Germany
Universität Tübingen; Med. Klinik; Innere Medizin I, Tübingen, , Germany
Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I, Ulm, , Germany
Laiko General Hospital Athen; Uni Clinic of Gastrenterology, Athens, , Greece
Agioi Anargiroi Hospital of Kifissia; University Internal Medicine Clinic, Nea Kifissia, , Greece
Anticancer Hospital of Thessaloniki " Theagenio", Thessaloniki, , Greece
Hippokratio Hospital; 4Th Internal Medicine Dpt, Thessaloniki, , Greece
HealthCare Global Enterprises Limited; Medical Oncology, Banglore, Karnataka, India
Tata Memorial Hospital; Dept of Medical Oncology, Mumbai, Maharashtra, India
Rambam Health Care Campus; Oncology, Haifa, , Israel
Rabin Medical Center; Oncology Dept, Petah Tikva, , Israel
Sourasky Medical Center; Oncology Department, Tel-Aviv, , Israel
Fondazione Pascale; U.O. Sperimentazioni Cliniche, Napoli, Campania, Italy
Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica, Napoli, Campania, Italy
Ospedale del Mare; UOC di Oncologia, Napoli, Campania, Italy
A.O. S. Orsola Malpighi; Ambulatorio Epatocarcinoma (Bolondi), Bologna, Emilia-Romagna, Italy
Azienda Ospedaliera San Camillo Forlanini, Roma, Lazio, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Lazio, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia, Milano, Lombardia, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Piemonte, Italy
A.O.U. Policlinico Paolo Giaccone; Gastroenterologia ed Epatologia, Palermo, Sicilia, Italy
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1, Firenze, Toscana, Italy
Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2, Pisa, Toscana, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda, Padova, Veneto, Italy
Fujita Health University Hospital, Aichi, , Japan
Chiba University Hospital, Chiba, , Japan
National Cancer Center Hospital East, Chiba, , Japan
Kurume University Hospital, Fukuoka, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
Japanese Red Cross Society Himeji Hospital, Hyogo, , Japan
Yokohama City University Medical Center, Kanagawa, , Japan
Osaka University Hospital, Osaka, , Japan
Kindai University Hospital, Osaka, , Japan
Jichi Medical University Hospital, Tochigi, , Japan
Toranomon Hospital, Tokyo, , Japan
Japanese Red Cross Musashino Hospital, Tokyo, , Japan
National Cancer Center, Goyang-si, , Korea, Republic of
CHA Bundang Medical Center, Gyeonggi-do, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Uni Malaya Medical Center; Clinical Oncology Unit, Menara Timur, Kuala Lumpur, FED. Territory OF Kuala Lumpur, Malaysia
Institute Kanser Negara (IKN), Putrajaya, FED. Territory OF Kuala Lumpur, Malaysia
Beacon International Specialist Centre; Clinical Research Department, Level 2, Petaling Jaya, Selangor, Selangor, Malaysia
Cebu Doctors' University Hospital; Research Office, Cebu City, , Philippines
Makati Medical Center, Makati City, , Philippines
The Medical City; Cancer Center, Pasig City, , Philippines
Chelyabinsk Regional Clinical Oncology Dispensary, Chelyabinsk, Moskovskaja Oblast, Russian Federation
FSBI "National Medical Research Center of Oncology N.N. Blokhin?, Moscow, Moskovskaja Oblast, Russian Federation
Moscow City Oncology Hospital #62; Outpatient Care Center, Moscow, Moskovskaja Oblast, Russian Federation
Group of companies "Medci", Moskva, Moskovskaja Oblast, Russian Federation
I.M.Sechenov First Moscow State Medical University (1st MSMU), Moskva, Moskovskaja Oblast, Russian Federation
Clinical Hospital Lapino (LLC Haven), Yudino, Moskovskaja Oblast, Russian Federation
LLC "Oncology scientific centre", Pesochny, Sankt Petersburg, Russian Federation
University Medical Center Ljubljana; Clinical Dept. of Gastroenterology, Ljubljana, , Slovenia
Corporacio Sanitaria Parc Tauli; Servicio de Hepatologia, Sabadell, Barcelona, Spain
Hospital Son Llatzer; Servicio de Oncologia, Palma de Mallorca, Islas Baleares, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia, Santiago de Compostela, LA Coruña, Spain
Clinica Universitaria de Navarra; Servicio de Hepatologia, Pamplona/iruña, Navarra, Spain
Hospital Universitari Vall d'Hebron; Servicio de Hepatologia, Barcelona, , Spain
Hospital Universitario Reina Sofia; Servicio de Hepatologia, Cordoba, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Aparato Digestivo, Madrid, , Spain
Clinica Universidad de Navarra Madrid; Servicio de Oncología, Madrid, , Spain
Hospital Clinico San Carlos; Servicio de Oncologia, Madrid, , Spain
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC, Madrid, , Spain
Hospital Universitario la Fe; Servicio de Oncologia, Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza, , Spain
Inselspital Bern Medizin Gastroenterologie, Bern, , Switzerland
Universitätsspital Zürich Medizin Gastroenterologie; Klinik für Gastroenterologie und Hepatologie, Zürich, , Switzerland
Chi-Mei Medical Centre; Hematology & Oncology, Tainan, , Taiwan
National Taiwan University Hospital; Oncology, Zhongzheng Dist., , Taiwan
Chulalongkorn Hospital; Medical Oncology, Bangkok, , Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok, , Thailand
Adana Ac?badem Hospital Oncology Department, Adana, , Turkey
Memorial Ankara Hastanesi, Ankara, , Turkey
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji, Bakirkoy / Istanbul, , Turkey
Uludag Uni Hospital; Oncology, Bursa, , Turkey
Medipol Mega Üniversite Hastanesi Göztepe, Istanbul, , Turkey
Ege Uni Medical Faculty Hospital; Oncology Dept, Izmir, , Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Sihhiye/Ankara, , Turkey
Ac?badem Altunizade Hastanesi; Oncology, Üsküdar, , Turkey
Queen Elizabeth Hospital; Hepatobiliary Unit, Birmingham, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, , United Kingdom
Royal Free Hospital, London, , United Kingdom
King College Hospital NHS Foundation Trust, London, , United Kingdom
Hammersmith Hospital; Clinical trials unit, London, , United Kingdom
Christie Hospital Nhs Trust; Medical Oncology, Manchester, , United Kingdom
Freeman Hospital; Gastroenterology & Liver Unit, Newcastle Upon Tyne, , United Kingdom
Churchill Hospital; Department of Oncology, Oxford, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR