Phase
Condition
Digestive System Neoplasms
Gall Bladder Cancer
Biliary Tract Cancer
Treatment
Placebo
Bevacizumab
Gemcitabine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Considered to be eligible to receive platinum-based chemotherapy, in theinvestigator's judgment
Documentation of recurrent/metastatic or locally advanced unresectable disease basedon computed tomography (CT) or magnetic resonance imaging (MRI) scans
Histologically or cytologically confirmed diagnosis of iCCA, eCCA, or GBC
No prior systemic therapy for advanced BTC
At least one measurable untreated lesion (per RECIST v1.1)
Adequate biliary drainage with no evidence of ongoing infection
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Life expectancy of > 3 months
Adequate hematologic and end-organ function
For women of childbearing potential: agreement to remain abstinent (refrain fromheterosexual intercourse) or use contraceptive methods, and agreement to refrainfrom donating eggs
For men: agreement to remain abstinent (refrain from heterosexual intercourse) oruse a condom, and agreement to refrain from donating sperm
Exclusion
Exclusion Criteria:
Recurrent disease <=6 months after curative surgery or <= 6 months after thecompletion of adjuvant therapy
Prior local regional therapy such as radioembolization
Combined or mixed hepatocellular/cholangiocarcinoma
Clinically significant hepatic encephalopathy within the 12 months prior to Day 1 ofCycle 1
National Cancer Institute Common Terminoogy Criteria for Adverse Events Grade >= 2peripheral neuropathy
Prior bleeding event due to untreated or incompletely treated esophageal and/orgastric varices within 6 months prior to Day 1 of Cycle 1
Pregnant or breastfeeding, or intending to become pregnant during the study orwithin 5 months after the final dose of atezolizumab or within 6 months after thefinal dose of bevacizumab, cisplatin or gemcitabine
Active or history of autoimmune disease or immune deficiency
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-inducedpneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis onscreening chest computed tomography scan
History of malignancy other than BTC within 5 years prior to screening, with theexception of malignancies with a negligible risk of metastasis or death
Symptomatic, untreated, or actively progressing CNS metastases
For patients with lung metastases, if one of the following criteria applies: Large,centrally located pulmonary metastases; Clear tumor infiltration into the thoracicgreat vessels seen on imaging; Clear cavitation of pulmonary lesions seen on imaging
Active tuberculosis
Co-infection with HBV and HCV
Treatment with systemic immunostimulatory agents or immunosuppressive medication
Inadequately controlled arterial hypertension
History of hypertensive crisis or hypertensive encephalopathy
Significant vascular disease
Evidence of bleeding diathesis or significant coagulopathy
Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)
Preexisting renal impairment, myelosuppression, or hearing impairment
Study Design
Connect with a study center
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario L1G 2B9
CanadaSite Not Available
Sunnybrook Odette Cancer Centre; Clinical Trials
Toronto, Ontario M4N 3M5
CanadaSite Not Available
McGill University Health Center
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Centre Universitaire de sante de l'Estrie (CHUS)
Sherbrooke, Quebec J1H 5N4
CanadaSite Not Available
Beijing Union Hospital
Beijing, 100730
ChinaSite Not Available
the First Hospital of Jilin University
Changchun, 130021
ChinaSite Not Available
Nanfang Hospital, Southern Medical University
Guangzhou, 510515
ChinaSite Not Available
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou City, 310016
ChinaSite Not Available
Harbin Medical University Tumor Hospital
Harbin City, 150081
ChinaSite Not Available
Nan Tong Tumor Hospital
Nantong,
ChinaSite Not Available
Nan Tong Tumor Hospital
Nantong City, 226361
ChinaSite Not Available
Zhongshan Hospital Fudan University
Shanghai, 200032
ChinaSite Not Available
Centre Antoine Lacassagne
Nice, 06189
FranceSite Not Available
Chu La Miletrie; Gastro Enterologie Endoscopies
Poitiers, 86021
FranceSite Not Available
CHU de Saint-Etienne - Hopital Nord
Saint Etienne, 42055
FranceSite Not Available
Institut Gustave Roussy; Gastro-Enterologie
Villejuif, 94805
FranceSite Not Available
Queen Mary Hospital; Dept. Of Haematology & Oncology
Hong Kong,
Hong KongSite Not Available
Prince of Wales Hosp; Dept. Of Clinical Onc
Shatin,
Hong KongSite Not Available
Fondazione Pascale; U.O. Sperimentazioni Cliniche
Napoli, Campania 80100
ItalySite Not Available
Azienda Ospedaliero Universitaria di Bologna; Istituto di Ematologia "Lorenzo e Ariosto Seragnoli"
Bologna, Emilia-Romagna 40139
ItalySite Not Available
Azienda Ospedaliera S. Gerardo; Gastroenterologia
Monza, Lombardia 20900
ItalySite Not Available
Istituto Clinico Humanitas - Humanitas Cancer Center
Rozzano, Sicilia 20089
ItalySite Not Available
Azienda Ospedaliero Universitaria Pisana; Unita Operativa Medica
Pisa, Toscana 56126
ItalySite Not Available
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padova, Veneto 35128
ItalySite Not Available
CHA Bundang Medical Center
Gyeonggi-do, 13496
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, 463-707
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
Bydgoszcz, 85-796
PolandSite Not Available
SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej
Bytom, 41-902
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Gda?sk, 80-214
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Gdansk, 80-214
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Gdańsk, 80-214
PolandSite Not Available
Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii
Koszalin, 75-581
PolandSite Not Available
NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii
Warszawa, 02-034
PolandSite Not Available
Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii
Wroc?aw, 53-413
PolandSite Not Available
Dolnośląskie Centrum Onkologii; Oddział Onkologii Klinicznej i Chemioterapii
Wrocław, 53-413
PolandSite Not Available
FSBI "National Medical Research Center of Oncology N.N. Blokhin?
Moscow, Moskovskaja Oblast 115478
Russian FederationSite Not Available
First Moscow State Medical University n.a. I.M. Sechenov
Moscow, Moskovskaja Oblast 119991
Russian FederationSite Not Available
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
Moskva, Moskovskaja Oblast 111123
Russian FederationSite Not Available
Clinical hospital #1, FBHI Volga district medical center, Federal Medical and Biological Agency
Nizhny Novgorod, Niznij Novgorod 603109
Russian FederationSite Not Available
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
Saint Petersburg, Sankt Petersburg 197758
Russian FederationSite Not Available
Hospital General Universitario de Elche; Servicio de Oncologia
Elche, Alicante 03203
SpainSite Not Available
Complejo Hospitalario de Navarra; Servicio de Oncologia
Pamplona, Navarra 31008
SpainSite Not Available
Hospital Universitari Vall d'Hebron; Oncology
Barcelona, 08035
SpainSite Not Available
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, 28034
SpainSite Not Available
Complejo Hospitalario de Orense; Servicio de Oncologia
Orense, 32005
SpainSite Not Available
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, 50009
SpainSite Not Available
National Taiwan Uni Hospital; Dept of Oncology
Taipei, 100
TaiwanSite Not Available
Taipei Veterans General Hospital; Department of Oncology
Taipei City, 112201
TaiwanSite Not Available
Chang Gung Memorial Hospital-Linkou; Dept of Oncology
Taoyuan County, 333
TaiwanSite Not Available
Maharaj Nakorn Chiang Mai Hosp; Oncology Unit
Chiangmai, 50200
ThailandSite Not Available
Srinagarind Hospital; Medical Oncology Unit
Khon Kaen, 40002
ThailandSite Not Available
Sunpasitthiprasong Hospital; Oncology and/or Hematology
Ubon Ratchathani, 34000
ThailandSite Not Available
Adana Ac?badem Hospital Oncology Department
Adana, 01130
TurkeySite Not Available
Memorial Ankara Hastanesi
Ankara, 06520
TurkeySite Not Available
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, 34300
TurkeySite Not Available
Ege Uni Medical Faculty Hospital; Oncology Dept
Izmir, 35100
TurkeySite Not Available
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya, 44280
TurkeySite Not Available
Koc Universitesi Hastanesi; T?bbi Onkoloji
Zeyt?nburnu, 34010
TurkeySite Not Available
Koc Universitesi Hastanesi; Tıbbi Onkoloji
Zeyti̇nburnu, 34010
TurkeySite Not Available
SI "Shalimov National Institute of Surgery and Transplantation" of Nat.Acad of Med.Sci of Ukraine
Kyiv, KIEV Governorate 03126
UkraineSite Not Available
?Kharkov Regional Oncology Center
Kharkiv, Kharkiv Governorate 61070
UkraineSite Not Available
SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU
Kharkiv, Kharkiv Governorate 61018
UkraineSite Not Available
Bristol Royal Infirmary
Bristol, BS2 8HW
United KingdomSite Not Available
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
United KingdomSite Not Available
Royal Free Hospital
London, NW3 2QS
United KingdomSite Not Available
Churchill Hospital
Oxford, OX3 7LJ
United KingdomSite Not Available
Royal Marsden Hospital (Sutton)
Sutton, SM2 5PT
United KingdomSite Not Available
Newport Beach UC Irvine Medical Center
Costa Mesa, California 92627
United StatesSite Not Available
City of Hope Cancer Center
Duarte, California 91010
United StatesSite Not Available
Kaiser Permanente Los Angeles
Los Angeles, California 90027
United StatesSite Not Available
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
United StatesSite Not Available
UC Irvine Medical Center
Orange, California 92868
United StatesSite Not Available
California Pacific Med Center
San Francisco, California 94115
United StatesSite Not Available
City of Hope-South Pasadena
South Pasadena, California 91030
United StatesSite Not Available
City of Hope; Upland
Upland, California 91786
United StatesSite Not Available
MedStar Washington Hosp Center
Washington, District of Columbia 20010
United StatesSite Not Available
University of Iowa
Iowa City, Iowa 52242
United StatesSite Not Available
Hematology Oncology Clinic
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Duke Cancer Center
Durham, North Carolina 27710
United StatesSite Not Available
SCRI-Tennessee Oncology
Nashville, Tennessee 37203
United StatesSite Not Available
Sarah Cannon Research Institute / Tennessee Oncology
Nashville, Tennessee 37203
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22903
United StatesSite Not Available

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