Spots Global Cancer Trial Database for Phase 3 Study of Tislelizumab Versus Sorafenib in Participants With Unresectable HCC
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Trial Identification
Brief Title: Phase 3 Study of Tislelizumab Versus Sorafenib in Participants With Unresectable HCC
Official Title: RATIONALE-301: A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma
Study ID: NCT03412773
Conditions
Study Description
Brief Summary: This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese participants. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese participants are recruited in this Phase 3 study.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Southern California Research Center, Coronado, California, United States
St. Jude Heritage Healthcare, Fullerton, California, United States
University of California - Hematology and Oncology, Los Angeles, California, United States
Chao Family Comprehensive Cancer Center, Orange, California, United States
Inland Empire Liver Foundation, Rialto, California, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Healthcare Research Network III, LLC, Tinley Park, Illinois, United States
Ochsner Medical Center (OMC) - New Orleans ACCRU Network Sit, New Orleans, Louisiana, United States
University Medical Center New Orleans, New Orleans, Louisiana, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
UMass Memorial Medical Center, Worcester, Massachusetts, United States
Umdnj-Njms, Newark, New Jersey, United States
Northwell Health/Monter Cancer Center, Lake Success, New York, United States
White Plains Hospital Center for Cancer Care - Oncology, White Plains, New York, United States
Precision Cancer Research / Dayton Physicians Network, Kettering, Ohio, United States
Hahnemann University Hospital - Gastroenterology Hepatology, Philadelphia, Pennsylvania, United States
Cancer Treatment Centers of America - Oncology, Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center (VUMC), Nashville, Tennessee, United States
The Mays Cancer Center, San Antonio, Texas, United States
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
Anhui Provincial Hospital, Hefei, Anhui, China
The First Affiliated Hospital Of Anhui Medical University, Hefei, Anhui, China
Anhui Medical University - The Second Hospital, Hefei, Anhui, China
Beijing Cancer Hospital, Beijing, Beijing, China
Chinese PLA General Hospital, Beijing, Beijing, China
302 Military Hospital of China, Beijing, Beijing, China
Beijing YouAn Hospital, Capital Medical University, Beijing, Beijing, China
Cancer Hopital Chinese Academy of Medical Sciences, Beijing, Beijing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China
Guangdong General Hospital, Guangzhou, Guangdong, China
Nanfang Hospital, Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital , Sun Yat-sen University, Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Wuhan Union Hospital, Wuhan, Hubei, China
Nanjing Bayi Hospital, Nanjing, Jiangsu, China
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Jilin Cancer Hospital, Changchun, Jilin, China
The First Hospital of Jilin University, Changchun, Jilin, China
The Affiliated Hospital Of Qingdao University, Qingdao, Shandong, China
Weifang People's Hospital, Weifang, Shandong, China
Shanghai Cancer Hospital of Fudan University, Shanghai, Shanghai, China
Zhongshan Hospital Fudan University, Shanghai, Shanghai, China
The First Affiliated Hospital Of XI'AN Jiaotong University, Xian, Shanxi, China
Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, Sichuan, Sichuan, China
Zhongnan Hospital of Wuhan University, Wuhan, Wuhan, China
The First Affiliated Hospital of Zhejiang University, HangZhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Peking Union Medical College Hospital, Beijing, , China
The First Affiliated Hospital of Chongqing Medical University, Chongqing, , China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, , China
Fakultni nemocnice Brno, Brno, Brno-Mesto, Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice v Motole, Praha 5, , Czechia
CHU Amiens-Hopital Nord - Hépato-Gastroentérologie, Somme, Amiens, France
CHU Cote De Nacre - Hepato-Gastro-Enterologie Et N, Caen, Cedex 05, Basse-Normandie, France
Hôpital Privé des Côtes d'Armor - Service oncologie, Plérin, Bretagne, France
Hopital Robert DEBRE, CHU Reims, Reims, Champagne-Ardenne, France
Hospitalier Jean Minjoz, Besançon, Franche-Comté, France
CHU de Grenoble Alpes, La Tronche, Isere, France
Bichat-Beaujon Service Inter Hospitalier De Cancerologie, Clichy Cedex, Lie-de-France, France
Hopital Paul Brousse- Aphp Hopitaux Universitairees Paris Su, Villejuif, Lie-de-France, France
CHU Nantes -hopital hotel Dieu, Nantes, Loire-Atlantique, France
CHU Saint Etienne, Rahon, Lyon, France
CHRU De Lille - Hôpital Claude Huriez, Lille, Nord, France
CHU de Nice - Hôpital de l'Archet II, Nice, Provence-Alpes-Côte-d'Azur, France
CHU Saint Eloi - Pôle Digestif, Bretagne, Rennes Cedex, France
Gustave Roussy - Medical Oncology, Villejuif, Val-de-Marne, France
Hospital of Poitiers, Poitiers, Vienne, France
Krankenhaus Nordwest gGmbH, Frankfurt/Main, Hessen, Germany
Maria Gonzalez-Carmona, Bonn, Nordrhein-Westfalen, Germany
Stefan Pluntke, Essen, Nordrhein-Westfalen, Germany
Universitätsklinikum Düsseldorf, Düsseldorf, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitätsklinikum Köln, Köln, , Germany
Universitätsklinikum Leipzig AöR, Leipzig, , Germany
Universitätsmedizin Mainz, Mainz, , Germany
IRCCS Saverio De Bellis, AO Gastroenterologia, Castellana Grotte, Bari, Italy
Medical Oncology, Feltre, Belluno, Italy
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele di Catania, Catania, Catani, Italy
Ospedale S.Bortolo, AULSS n.6 Vicenza, Vicenza, Veneto, Italy
Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Malattie, Bologna, , Italy
PO di Cremona, ASST di Cremona - Oncologia - Cremona - Radiology, Cremona, , Italy
Ospedale Vito Fazzi, ASL Lecce, Lecce, , Italy
AOU Policlinico di Modena, Modena, , Italy
IRCCS Policlinico San Matteo, Pavia, , Italy
Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncologia, Pavia, , Italy
Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS, Roma, , Italy
PO Umberto I, AO Ordine Mauriziano, Torino, , Italy
Fujita Health University Hospital, Toyoake, Aiti [Aichi], Japan
Ehime Prefectural Central Hospital - Gastroenterology, Matsuyama, Ehime, Japan
Ogaki Municipal Hospital, Ogaki, Gihu [Gifu], Japan
Hokkaido University Hospital - Gastroenterology, Sapporo, Hokkaidô [Hokkaido], Japan
Kanazawa University Hospital, Kanazawa-shi, Isikawa [Ishikawa], Japan
Yokohama City University Medical Center, Yokohama, Kanagawa, Japan
Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
University Hospital, Kyoto Prefectural Univ of Medicine, Kyoto-shi, Kyôto [Kyoto], Japan
Nagasaki Medical Center, Omura, Nagasaki, Japan
Kinki University Hospital, Faculty of Medicine - Hematology & Clinical Oncology, Osaka-sayama, Osaka, Japan
Osaka University Hospital, Suita, Osaka, Japan
Chiba University Hospital, Chiba, Tiba [Chiba], Japan
Sasaki Foundation Kyoundo Hospital, Chiyoda-Ku, Tokyo, Japan
Nihon University Itabashi Hospital - Gastroenterological surgery, Itabashi-ku, Tôkyô [Tokyo], Japan
JRC Medical Center, Shibuya-ku, Tôkyô [Tokyo], Japan
National Center for Global Health and Medicine, Shinjuku-ku, Tôkyô [Tokyo], Japan
Kyushu Medical Center, Fukuoka, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Iwate Medical University Hospital, Morioka, , Japan
Hyogo College of Medicine Hospital, Nishinomiya-shi, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Tottori University Hospital, Tottori, , Japan
Wakayama Medical University, Wakayama-shi, , Japan
Osaka City General Hospital, Osaka, Ôsaka [Osaka], Japan
Osaka National Hospital, Osaka, Ôsaka [Osaka], Japan
Osaka City University Hospital, Osaka, Ôsaka [Osaka], Japan
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Warszawa, Mazowieckie, Poland
Clinical Research Center Sp. z o.o., Medic-R Sp. K., Poznan, Wielkopolskie, Poland
Uniwersyteckie Centrum Kliniczne, Gdańsk, , Poland
Wojewodzki Szpital Specjalistyczny im. Gromkowskiego we Wroclawiu, Wroclaw, , Poland
Institut Catalá d´Oncología (I.C.O.), Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Vall d'Hebrón, Barcelona, , Spain
Hospital Universitario Madrid Sanchinarro Centro integral Oncologico Clara Campal (CIOCC), Madrid, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Gastroenterology, Kaohsiung, , Taiwan
Kaohsiung Medical University - Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
Tri-Service General Hospital - Neihu Branch, New Taipei, , Taiwan
China Medical University Hospital - Transplantology - Taichung, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Chi Mei Medical Center - YongKang, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital, Taipei, , Taiwan
Queen Elizabeth Hospital - Clinical Reasearch, Birmingham, , United Kingdom
Royal Free Hospital London NHS Trust, London, , United Kingdom
King's College Hospital NHS Foundation Trust, London, , United Kingdom
The Christie NHS Foundation Trust - Oak Road Treatment Centre, Withington, , United Kingdom
Contact Details
Name: Yaxi Chen, MD
Affiliation: BeiGene
Role: STUDY_DIRECTOR
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