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A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

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研究单位: [1]Incyte Corporation [2]Mayo Clinic Arizona,Phoenix,Arizona,United States,85054 [3]Marin Cancer Care,Greenbrae,California,United States,94904 [4]Georgetown University-Lombardi Comprehensive Cancer Center,Washington,District of Columbia,United States,20007 [5]Mayo Clinic-Florida,Jacksonville,Florida,United States,32224 [6]Mount Sinai Medical Center Comprehensive Cancer Center,Miami Beach,Florida,United States,33140 [7]Winship Cancer Institute of Emory University,Atlanta,Georgia,United States,30322 [8]University of Chicago Medical Center,Chicago,Illinois,United States,60637-1447 [9]Parkview Research Center,Fort Wayne,Indiana,United States,46845 [10]University of Iowa Hospital and Clinics,Iowa City,Iowa,United States,52242 [11]The University of Kansas Cancer Center,Westwood,Kansas,United States,66205 [12]Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci,New Orleans,Louisiana,United States,70121 [13]Johns Hopkins Oncology Center,Baltimore,Maryland,United States,21287 [14]Boston Medical Center,Boston,Massachusetts,United States,02118 [15][16Beth Israel Deaconess Medical Center,Boston,Massachusetts,United States,02215 [16]Barbara Ann Karmanos Cancer Hospital,Detroit,Michigan,United States,48201 [17]Henry Ford Hospital,Detroit,Michigan,United States,48202 [18]Karmanos Cancer Institute,Farmington Hills,Michigan,United States,48334 [19]Mayo Clinic,Rochester,Minnesota,United States,55905 [20]Comprehensive Cancer Centers of Nevada-Twain,Las Vegas,Nevada,United States,89169 [21]Summit Medical Group,Florham Park,New Jersey,United States,07932 [22]Icahn School of Medicine At Mount Sinai,New York,New York,United States,10029 [23]White Plains Hospital,White Plains,New York,United States,10601 [24]University Hospitals Cleveland Medical Center,Cleveland,Ohio,United States,44106 [25]Cleveland Clinic Foundation,Cleveland,Ohio,United States,44195 [26]Providence Portland Med. Ctr,Portland,Oregon,United States,97213 [27]Oregon Health & Science University,Portland,Oregon,United States,97239 [28]Fox Chase Cancer Center,Philadelphia,Pennsylvania,United States,19111 [29]Greenville Hospital System University Medical Center Institute For Translational Oncology Research,Greenville,South Carolina,United States,29605 [30]Baylor Scott and White Research Institute,Dallas,Texas,United States,75246 [31]Houston Methodist Research Institute,Houston,Texas,United States,77030 [32]Riverside Regional Medical Center,Newport News,Virginia,United States,23601 [33]Virginia Commonwealth University,Richmond,Virginia,United States,23229 [34]Virginia Mason Medical Center,Seattle,Washington,United States,98101 [35]West Virginia University Cancer Institute,Morgantown,West Virginia,United States,26506 [36]Aurora Research Institute,Wauwatosa,Wisconsin,United States,53226 [37]Landeskrankenhaus Universitatsklinikum Graz,Graz,Austria,08036 [38]Innsbruck University Hospital,Innsbruck,Austria,A-6020 [39]Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz,Linz,Austria,04010 [40]Salzburger Universitatsklinikum,Salzburg,Austria,05020 [41]Landeskrankenhaus Steyr,Steyr,Austria,04400 [42]Allgemeines Krankenhaus Der Stadt Wien,Vienna,Austria,01090 [43]Ulb Hospital Erasme,Bruxelles,Belgium,01070 [44]Universitair Ziekenhuis Brussel,Bruxelles,Belgium,01090 [45]Universitair Ziekenhuis Gent,Gent,Belgium,09000 [46]Hospital de Jolimont,Haine-st-paul,Belgium,07100 [47]Az Groeninge Campus Kennedylaan,Kortrijk,Belgium,08500 [48]Universitaire Ziekenhuis Leuven - Gasthuisberg,Leuven,Belgium,03000 [49]Chu Ucl Namur University Hospital Mont-Godinne,Yvoir,Belgium,05530 [50]Tom Baker Cancer Centre,Calgary,Alberta,Canada,T2N 4N2 [51]Cancercare Manitoba,Winnipeg,Manitoba,Canada,R3E 0V9 [52]Nova Scotia Health Authority/Qeii Health Sciences Centre,Halifax,Nova Scotia,Canada,B3H 4K4 [53]Princess Margaret Cancer Center,Toronto,Ontario,Canada,MG5 2M9 [54]McGill University Health Centre Research Institute,Montreal,Quebec,Canada,H4A 3J1 [55]Peking Union Medical College Hospital,Beijing,China,100032 [56]West China Hospital Sichuan University,Chengdu,China,610041 [57]Fujian Cancer Hospital,Fuzhou,China,350005 [58]Sun Yat-Sen Memorial Hospital Sun Yat-Sen University,Guangdong,China,510000 [59]Sun Yat-Sen Memorial Hospital Sun Yat-Sen University,Guangzhou,China,510000 [60]Shulan Hangzhou Hospital Co Ltd,Hangzhou,China,310000 [61]The Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou,China,310009 [62]Heilongjiang Province Cancer Hospital,Harbin,China,150081 [63]University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital),Hefei,China,230001 [64]Kunming 1St People'S Hospital,Kunming,China,650032 [65]Jiangsu Province Hospital,Nanjing,China,210029 [66]The Affiliated Hospital of Qingdao University,Shandong,China,266071 [67]Zhongshan Hospital Fudan University,Shanghai,China,200032 [68]Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai,China,200092 [69]Xinhua Hospital,Shanghai,China,200092 [70]Sichuan Cancer Hospital,Sichuan,China,610041 [71]Tianjin Medical University Cancer Institute Hospital,Tianjin,China,300060 [72]Tongji Hospital Huazhong University of Science and Technology,Wuhan,China,430030 [73]Hubei Cancer Hospital,Wuhan,China,430079 [74]Northern Jiangsu Peoples Hospital,Yangzhou,China,225001 [75]Herlev Og Gentofte Hospital,Herlev,Denmark,02730 [76]Docrates Cancer Center,Helsinki,Finland,00180 [77]Helsinki University Central Hospital,Helsinki,Finland,00290 [78]Tampere University Hospital,Tampere,Finland,33521 [79]Institut Sainte Catherine,Avignon Cedex 9,France,84918 [80]Chu Besancon Hospital Jean Minjoz,Besançon,France,25030 [81]Institut Bergonie,Bordeaux Cedex,France,33076 [82]Hopital Beaujon,Clichy,France,92110 [83]Chu de Limoges - Hospital Dupuytren,Limoges Cedex,France,87042 [84]Hopital Prive Jean Mermoz,Lyon Cedex 08,France,69373 [85]Chu Hopital de La Timone,Marseille Cedex 5,France,13385 [86]Centre Hospitalier Universitaire de Nantes,Nantes,France,44000 [87]Centre Antoine Laccassagne,Nice Cedex 02,France,06189 [88]Hospital Universitaire Pitie-Salpetriere,Paris Cedex 13,France,75013 [89]Hopital Europeen Georges Pompidou (Hegp),Paris Cedex 15,France,75015 [90]Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque,Pessac Cedex,France,336600 [91]Hospital de La Miletrie,Poitiers Cedex,France,86021 [92]Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume,Rouen Cedex,France,76031 [93]University Hospital of Saint Etienne,Saint Etienne,France,42055 [94]Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau,Saint Herblain,France,44800 [95]Chu Toulouse Hopital Rangueil,Toulouse Cedex 9,France,31059 [96]Chu Vandoeuvre-Les-Nancy Hopital Brabois,Vandoeuvre Les Nancy,France,54511 [97]Institut Gustave Roussy,Villejuif Cedex,France,94805 [98]University Medical Center Rwth Aachen,Aachen,Germany,52074 [99]Charite - Campus Virchow-Klinikum,Berlin,Germany,13353 [100]Charite Universitaetsmedizin Berlin - Campus Charite Mitte,Berlin,Germany,13353 [101]Universitatsklinikum Bonn Aoer,Bonn,Germany,53127 [102]Klinikum Bremen-Nord,Bremen,Germany,28755 [103]University Clinic Carl Gustav Carus Technical University Dresden,Dresden,Germany,01307 [104]Klinikum Der Johann Wolfgang Goethe University,Frankfurt,Germany,60590 [105]University Medical Center Freiburg,Freiburg,Germany,79106 [106]Universitatsklinikum Hamburg Eppendorf,Hamburg,Germany,20246 [107]Asklepios Klinik Altona,Hamburg,Germany,22763 [108]Hannover Medical School,Hannover,Germany,30625 [109]Universitaetsklinikum Des Saarlandes,Homburg / Saar,Germany,66421 [110]Universitatsklinikum Koln,Koln,Germany,50937 [111]Universitatsklinikum Leipzig Aor,Leipzig,Germany,04103 [112]Klinikum Ludwigsburg,Ludwigsburg,Germany,71640 [113]Otto-Von-Guericke-Universitat Magdeburg,Magdeburg,Germany,39120 [114]Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii,Mainz,Germany,55131 [115]University Hospital Grosshadern Munich,Munich,Germany,81377 [116]Klinikum Nuernberg,Nuernberg,Germany,90419 [117]Universitaetsklinikum in Tubingen,Tubingen,Germany,72076 [118]University Hospital Tuebingen,Tubingen,Germany,72076 [119]Universitatkinikums Ulm,ULM,Germany,89081 [120]St. Vincent'S University Hospital,Dublin 4,Ireland,D04 Y8V0 [121]Soroka University Medical Center,Beer-sheva,Israel,84001 [122]Rambam Health Care Campus,Haifa,Israel,3109601 [123]Hadassah University Hospital,Jerusalem,Israel,9112001 [124]Rabin Medical Center - Beilinson Hospital,Petach Tikva,Israel,4941492 [125]Tel Aviv Sourasky Medical Center,Tel Aviv,Israel,64239 [126]Azienda Ospedaliero Universitaria Ospedali Riuniti,Ancona,Italy,60126 [127]Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari,Bari,Italy,70124 [128]Ospedale Papa Giovanni Xxiii,Bergamo,Italy,24127 [129]Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi,Bologna,Italy,40138 [130]Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo,Candiolo,Italy,10060 [131]Presidio Ospedaliero Garibaldi Nesima,Catania,Italy,95100 [132]Ospedale Degli Infermi - Faenza,Faenza,Italy,48018 [133]Irccs Azienda Ospedaliera Universitaria San Martino,Genova,Italy,16132 [134]Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano,Milano,Italy,20133 [135]Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele,Milan,Italy,20132 [136]European Institute of Oncology,Milan,Italy,20141 [137]Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda,Milan,Italy,20162 [138]A.O.U. Di Modena - Policlinico,Modena,Italy,41124 [139]Istituto Nazionale Tumori Irccs Fondazione Pascale,Napoli,Italy,80131 [140]Universita Degli Studi Della Campania Luigi Vanvitelli U.O.C. Oncologia Medica,Napoli,Italy,80138 [141]Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano,Orbassano,Italy,10043 [142]Iov - Istituto Oncologico Veneto Irccs,Padova,Italy,35128 [143]Presidio Ospedaliero Pescara,Pescara,Italy,65124 [144]Azienda Ospedaliera Universitaria Pisana,Pisa,Italy,56126 [145]Fondazione Policlinico Universitario Agostino Gemelli Irccs,Roma,Italy,00137 [146]Istituto Nazionale Tumori Regina Elena Irccs,Roma,Italy,00144 [147]Universita Campus Bio Medico Di Roma,Rome,Italy,00128 [148]Azienda Ospedaliera San Camillo Forlanini,Rome,Italy,00152 [149]Irccs Istituto Clinico Humanitas,Rozzano,Italy,20089 [150]Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte,Siena,Italy,53100 [151]Centro Ricerche Cliniche Di Verona (Crc),Verona,Italy,37134 [152]San Bartolo Hospital,Vicenza,Italy,36100 [153]University of Tokyo Hospital,Bunkyo,Japan,113-8655 [154]Chiba University Hospital,Chiba,Japan,260-8677 [155]Chiba Cancer Center,Chiba,Japan,260-8717 [156]National Hospital Organization Kyushu Cancer Center,Fukuoka-shi,Japan,812-8582 [157]National Hospital Organization Kyushu Cancer Center,Fukuoka,Japan,811-1395 [158]Hiroshima University Hospital,Hiroshima-shi,Japan,734-8551 [159]Hokkaido University Hospital,Hokkaido,Japan,060-8648 [160]Hyogo College of Medicine Hospital,Hyogo,Japan,663-8501 [161]Kanazawa University Hospital,Ishikawa,Japan,920-8641 [162]Teikyo University Hospital,Itabashi-ku,Japan,173-8606 [163]Kobe University Hospital,Kobe-shi,Japan,650-0017 [164]Cancer Institute Hospital of Jfcr,Koto-ku,Japan,135-8550 [165]Kyoto University Hospital,Kyoto-shi,Japan,606-8507 [166]Nho Shikoku Cancer Center,Matsuyama-shi,Japan,791-0280 [167]Kyorin University Hospital,Mitaka-shi,Japan,181-8611 [168]Aichi Cancer Center Hospital,Nagoya-shi,Japan,464-8681 [169]Niigata Cancer Center Hospital,Niigata,Japan,951-8566 [170]Osaka International Cancer Institute,Osaka-shi,Japan,541-8567 [171]Kindai University Hospital,Osakasayama City,Japan,589-8511 [172]Saitama Cancer Center,Saitama,Japan,362-0806 [173]Tohoku University Hospital,Sendai-shi,Japan,980-8574 [174]Jichi Medical University Hospital,Shimotsuke-shi,Japan,329-0498 [175]Keio University Hospital,Shinjuku-ku,Japan,160-8582 [176]Shizuoka Cancer Center,Shizuoka,Japan,411-8777 [177]Osaka University Hospital,Suita-shi,Japan,565-0871 [178]Toyama University Hospital,Toyama,Japan,930-0194 [179]Yamaguchi University Hospital,UBE,Japan,755-8505 [180]Wakayama Medical University Hospital,Wakayama,Japan,641-8509 [181]Yokohama City University Medical Center,Yokohama-shi,Japan,232-0024 [182]Kanagawa Cancer Center,Yokohama-shi,Japan,241-8515 [183]Oita University Hospital,Yufu-shi,Japan,879-5593 [184]Amsterdam University Medical Centre,Amsterdam,Netherlands,1100 DD [185]Maastricht Umc+,Maastricht,Netherlands,6202 AZ [186]Erasmus Medical Center,Rotterdam,Netherlands,3015 CE [187]Umc Utrecht,Utrecht,Netherlands,3584 CX [188]Oslo University Hospital,Oslo,Norway,00450 [189]Hospital de La Santa Creu I Sant Pau,Barcelona,Spain,08026 [190]Hospital General Universitario Vall D Hebron,Barcelona,Spain,08035 [191]Hospital Clinic Barcelona Main,Barcelona,Spain,08036 [192]Hospital Clinic Barcelona Main,Barcelona,Spain,08036 [193]Hospital Universitario Reina Sofia,Cordoba,Spain,14004 [194]Hospital Universitario Reina Sofia,Córdoba,Spain,14004 [195]Hospital Materno Teresa Herrera,La Coruña,Spain,15006 [196]Hospital General Universitario Gregorio Maranon,Madrid,Spain,28007 [197]Hospital Universitario Ramon Y Cajal,Madrid,Spain,28034 [198]Hospital Universitario Hm Sanchinarro,Madrid,Spain,28050 [199]Hospital Regional Universitario de Malaga,Málaga,Spain,29010 [200]Clinica Universidad de Navarra (Cun),Pamplona,Spain,31008 [201]Hospital Universitari Parc Tauli,Sabadell,Spain,08208 [202]HOSPITAL UNiVERSITARIO DONOSTIA,San Sebastian,Spain,20014 [203]Hospital Universitario Marques de Valdecilla,Santander,Spain,39008 [204]Hospital General Universitario de Valencia,Valencia,Spain,46014 [205]Sahlgrenska University Hospital,Göteborg,Sweden,413 46 [206]Karolinska Institute Universitetssjukhuset Solna,Solna,Sweden,171 64 [207]Inselspital - Universitaetsspital Bern,Bern,Switzerland,03010 [208]Universitatsspital Zurich,Zuerich,Switzerland,08091 [209]Aberdeen Royal Infirmary,Aberdeen,United Kingdom,AB25 2ZN [210]Addenbrooke'S Hospital,Cambridge,United Kingdom,CB2 0QQ [211]Velindre Cancer Centre,Cardiff,United Kingdom,CF14 2TL [212]University Hospital Coventry and Warwickshire,Coventry,United Kingdom,CV2 2DX [213]The Royal Marsden Nhs Foundation Trust - Chelsea,London,United Kingdom,SW3 6JJ [214]Imperial College Healthcare Nhs Trust - Hammersmith Hospital,London,United Kingdom,W12 0HS [215]University College London Hospitals (Uclh),London,United Kingdom,WC1E 6BT [216]Kent Oncology Centre - Maidstone Hospital,Maidstone,United Kingdom,ME16 9QQ [217]The Christie Nhs Foundation Trust,Manchester,United Kingdom,M20 4BV [218]The Royal Marsden Nhs Foundation Trust - Sutton,Sutton,United Kingdom,SM2 5PT

关键词: Cholangiocarcinoma fibroblast growth factor receptor inhibitor FGFR FGFR rearrangement

研究目的:
The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.

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