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Brief Title: A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer
Official Title: A Phase II, Randomized, Double-Blind Placebo-Controlled Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer
Study ID: NCT04677504
Brief Summary: This study will evaluate the efficacy and safety of atezolizumab with bevacizumab in combination with cisplatin and gemcitabine(CisGem), compared with atezolizumab in combination with CisGem, in participants with advanced biliary tract cancer (BTC) who have not received prior systemic therapy. Treatment will consist of a chemotherapy combination phase followed by a cancer immunotherapy (CIT)/placebo phase.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope Cancer Center, Duarte, California, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Duke Cancer Center, Durham, North Carolina, United States
SCRI-Tennessee Oncology, Nashville, Tennessee, United States
University of Virginia, Charlottesville, Virginia, United States
Nanfang Hospital, Southern Medical University, Guangzhou, , China
Sir Run Run Shaw Hospital Zhejiang University, Hangzhou City, , China
Zhongshan Hospital Fudan University, Shanghai, , China
Queen Mary Hospital; Dept. Of Haematology & Oncology, Hong Kong, , Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc, Shatin, , Hong Kong
Fondazione Pascale; U.O. Sperimentazioni Cliniche, Napoli, Campania, Italy
Azienda Ospedaliero Universitaria di Bologna; Istituto di Ematologia "Lorenzo e Ariosto Seragnoli", Bologna, Emilia-Romagna, Italy
Istituto Clinico Humanitas - Humanitas Cancer Center, Rozzano, Sicilia, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II, Padova, Veneto, Italy
CHA Bundang 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
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej, Bytom, , Poland
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii, Gda?sk, , Poland
Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii, Koszalin, , Poland
NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii, Warszawa, , Poland
Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii, Wroc?aw, , Poland
FSBI "National Medical Research Center of Oncology N.N. Blokhin?, Moscow, Moskovskaja Oblast, Russian Federation
First Moscow State Medical University n.a. I.M. Sechenov, Moscow, Moskovskaja Oblast, Russian Federation
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM", Moskva, Moskovskaja Oblast, Russian Federation
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology), Saint Petersburg, Sankt Petersburg, Russian Federation
Complejo Hospitalario de Navarra; Servicio de Oncologia, Pamplona, Navarra, Spain
Hospital Universitari Vall d'Hebron; Oncology, Barcelona, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Complejo Hospitalario de Orense; Servicio de Oncologia, Orense, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza, , Spain
Taipei Veterans General Hospital; Department of Oncology, Taipei City, , Taiwan
National Taiwan Uni Hospital; Dept of Oncology, Taipei, , Taiwan
Maharaj Nakorn Chiang Mai Hosp; Oncology Unit, Chiangmai, , Thailand
Srinagarind Hospital; Medical Oncology Unit, Khon Kaen, , Thailand
Sunpasitthiprasong Hospital; Oncology and/or Hematology, Ubon Ratchathani, , Thailand
Adana Ac?badem Hospital Oncology Department, Adana, , Turkey
Memorial Ankara Hastanesi, Ankara, , Turkey
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department, Malatya, , Turkey
Koc Universitesi Hastanesi; T?bbi Onkoloji, Zeyt?nburnu, , Turkey
SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU, Kharkiv, Kharkiv Governorate, Ukraine
?Kharkov Regional Oncology Center, Kharkiv, Kharkiv Governorate, Ukraine
SI "Shalimov National Institute of Surgery and Transplantation" of Nat.Acad of Med.Sci of Ukraine, Kyiv, KIEV Governorate, Ukraine
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Royal Free Hospital, London, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Royal Marsden Hospital (Sutton), Sutton, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR