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Brief Title: A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation
Official Title: A Phase III, Multicenter, Randomized, Open-Label Study of Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation
Study ID: NCT04102098
Brief Summary: This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Kaiser Permanente Los Angeles, Los Angeles, California, United States
Mercy Medical Center, Baltimore, Maryland, United States
Henry Ford Health System, Detroit, Michigan, United States
Columbia University Medical Center, New York, New York, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
The University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Swedish Cancer Inst., Seattle, Washington, United States
St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
Riverina Cancer Care Centre, Wagga Wagga, New South Wales, Australia
Lkh-Univ. Klinikum Graz, Graz, , Austria
Klinikum Klagenfurt am Wörtersee; Abt.Gastroenterologie&Hepatologie,Endokrinologie, Klagenfurt, , Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie, Wien, , Austria
Imeldaziekenhuis, Bonheiden, , 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 do Cancer UOPECCAN; Pesquisa Clínica, Cascavel, PR, Brazil
Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil
Hospital Alemao Oswaldo Cruz; Oncologia, Sao Paulo, SP, Brazil
Gordon & Leslie Diamond Health Care Centre, Vancouver, British Columbia, Canada
McGill University Health Centre - Glen Site, Montreal, Quebec, Canada
Peking Union Medical College Hospital, Beijing City, , China
Beijing Cancer Hospital, Beijing, , China
Affiliated Hospital of Bengbu Medical College, Bengbu, , China
The First Hospital of Jilin University, Changchun City, , China
West China Hospital, Sichuan University, Chengdu, , China
Daping Hospital of Third Military Medical University, Chongqing, , China
The Second Affiliated Hospital of Dalian Medical University, Dalian, , China
Mengchao Hepatobiliary Hospital Of Fujian Medical University, Fuzhou City, , China
Fujian Cancer Hospital, Fuzhou, , China
Sun Yet-sen University Cancer Center, Guangzhou City, , China
Cancer Center of Guangzhou Medical University, Guangzhou, , China
Zhujiang Hospital, Southern Medical University, Guangzhou, , China
Nanfang Hospital, Southern Medical University, Guangzhou, , China
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department, Hangzhou City, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Anhui Province Cancer Hospital, Hefei City, , China
Anhui Provincial Hospital, Hefei, , China
The Second Affiliated Hospital of Anhui Medical University, Hefei, , China
Shandong Cancer Hospital, Jinan, , China
The 81st Hospital of P.L.A., Nanjing City, , China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing City, , China
Zhongda Hospital Affiliated to Southeast University, Nanjing, , China
Guangxi Cancer Hospital of Guangxi Medical University, Nanning City, , China
The First Affiliate Hospital of Guangxi Medical University, Nanning, , China
Zhongshan Hospital Fudan Unvierstiy, Shanghai City, , China
Huashan Hospital Affiliated to Fudan University, Shanghai City, , China
Fudan University Shanghai Cancer Center, Shanghai City, , China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, , China
The First Affiliated Hospital of China Medical University, Shenyang City, , China
Shengjing Hospital of China Medical University, ShenYang, , China
Tianjin Cancer Hospital, Tianjin, , China
The Tumor Hospital of Xinjiang Medical University, Urumqi, , China
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan City, , China
Renmin Hospital of Wuhan University, Wuhan, , China
Zhongnan Hospital of Wuhan University, Wuhan, , China
Hubei Cancer Hospital, Wuhan, , China
Northern Jangsu People's Hospital, Yangzhou City, , China
Clinica CIMCA, San José, , Costa Rica
Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika, Brno, , Czechia
Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni, Praha, , Czechia
Hopital Jean Minoz; Oncologie, Besancon, , France
Hôpital Avicenne - Groupement Hospitalier Universitaire Paris Seine St Denis; Service d'Hépatologie, Bobigny Cedex, , France
Hôpital Albert Michallon, La Tronche, , France
Fondation Hopital Saint Joseph; Gastro-Enterologie, Marseille, , France
CHU Bordeaux - Hôpital Haut-Lévêque; Service d?Hépato-Gastroentérologie et d Oncologie digestive, Pessac, , France
Hopital Robert Debre; Gastro Enterologie, Reims, , France
Hopital de Pontchaillou; Service Hepato Gastro Enterologie, Rennes, , France
CHU de Toulouse - Hôpital Rangueil, Toulouse Cedex 09, , France
Hopitaux de Brabois - Gastro-Entereologie, Vandoeuvre-les-nancy, , France
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I.; Onkologische Gastroenterologie, Bonn, , Germany
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I, Frankfurt, , Germany
Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie, Regensburg, , Germany
Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I, Ulm, , Germany
Queen Mary Hospital; Dept. Of Haematology & Oncology, Hong Kong, , Hong Kong
Prince of Wales Hospital; Department of Clinical Onocology, Shatin, , Hong Kong
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica, Parma, Emilia-Romagna, Italy
Ospedale Maggiore Policlinico; U.O.C. di Oncologia Medica, Milano, Lombardia, Italy
Asst Santi Paolo E Carlo, Milano, Lombardia, Italy
Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2, Pisa, Toscana, Italy
Chiba University Hospital, Chiba, , Japan
Ehime Prefectural Central Hospital, Ehime, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
Sapporo Kosei Genaral Hospital, Hokkaido, , Japan
Hyogo Medical University Hospital, Hyogo, , Japan
Japanese Red Cross Society Himeji Hospital, Hyogo, , Japan
Kanazawa University Hospital, Ishikawa, , Japan
Yokohama City University Medical Center, Kanagawa, , Japan
Kanagawa Cancer Center, Kanagawa, , Japan
Kitasato University Hospital, Kanagawa, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Osaka Red Cross Hospital, Osaka, , Japan
Kindai University Hospital, Osaka, , Japan
Tokushima University Hospital, Tokushima, , Japan
Toranomon Hospital, Tokyo, , Japan
The University of Tokyo Hospital, Tokyo, , Japan
Japanese Red Cross Musashino Hospital, Tokyo, , Japan
Pusan National University Hospital, Busan, , Korea, Republic of
Kyungpook National University Hospital, Daegu, , Korea, Republic of
CHA Bundang Medical Center, Gyeonggi-do, , Korea, Republic of
Ajou University Medical Center, Gyeonggi-do, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul St Mary's Hospital, Seoul, , Korea, Republic of
Borame Medical Center, Seoul, , Korea, Republic of
Ulsan University Hosiptal, Ulsan, , Korea, Republic of
Centro Medico Dalinde, Cdmx, Mexico CITY (federal District), Mexico
Filios Alta Medicina, Monterrey, Nuevo LEON, Mexico
Oaxaca Site Management Organization, Oaxaca de Juárez, Oaxaca, Mexico
Maastricht University Medical Center, Maastricht, , Netherlands
Auckland City Hospital, Auckland, , New Zealand
Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel, Lima, , Peru
Instituto Nacional de Enfermedades Neoplasicas, Lima, , Peru
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Onkologii i Radioterapii,, Warszawa, , Poland
First Moscow State Medical University n.a. I.M. Sechenov, Moscow, Moskovskaja Oblast, Russian Federation
Group of companies "Medci", Moskva, Moskovskaja Oblast, Russian Federation
Clinical hospital #1, FBHI Volga district medical center, Federal Medical and Biological Agency, Nizhny Novgorod, Niznij Novgorod, Russian Federation
Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology, Pesochny, Sankt Petersburg, Russian Federation
National Cancer Centre, Singapore, , Singapore
Tan Tock Seng Hospital; Oncology, Singapore, , Singapore
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain
Hospital Universitario Infanta Cristina; Servicio de Oncologia, Badajoz, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Changhua Christian Hospital, Chang Hua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, , Taiwan
National Taiwan Uni Hospital; Dept of Oncology, Taipei, , Taiwan
Taipei Veterans General Hospital; Gastroenterology Division, Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology, Taoyuan, , Taiwan
Rajavithi Hospital; Division of Medical Oncology, Bangkok, , Thailand
Siriraj Hospital; Medical Oncology Unit, Bangkok, , Thailand
Chiang Rai Prachanukroh Hospital; Department Of Medicine, Chiang Rai, , Thailand
Chulabhorn Hospital; Medical Oncology, Lak Si, , Thailand
Adana Baskent University Hospital; Medical Oncology, Adana, , Turkey
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR