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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]Beth 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 Mason Medical Center,Seattle,Washington,United States,98101 [34]West Virginia University Cancer Institute,Morgantown,West Virginia,United States,26506 [35]Aurora Research Institute,Wauwatosa,Wisconsin,United States,53226 [36]Landeskrankenhaus Universitatsklinikum Graz,Graz,Austria,08036 [37]Innsbruck University Hospital,Innsbruck,Austria,A-6020 [38]Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz,Linz,Austria,04010 [39]Salzburger Universitatsklinikum,Salzburg,Austria,05020 [40]Landeskrankenhaus Steyr,Steyr,Austria,04400 [41]Allgemeines Krankenhaus Der Stadt Wien,Vienna,Austria,01090 [42]Ulb Hospital Erasme,Bruxelles,Belgium,01070 [43]Universitair Ziekenhuis Brussel,Bruxelles,Belgium,01090 [44]Universitair Ziekenhuis Gent,Gent,Belgium,09000 [45]Hospital de Jolimont,Haine-st-paul,Belgium,07100 [46]Az Groeninge Campus Kennedylaan,Kortrijk,Belgium,08500 [47]Universitaire Ziekenhuis Leuven - Gasthuisberg,Leuven,Belgium,03000 [48]Chu Ucl Namur University Hospital Mont-Godinne,Yvoir,Belgium,05530 [49]University of Calgary - Cumming School of Medicine,Calgary,Alberta,Canada,T2N 4N1 [50]Cancercare Manitoba,Winnipeg,Manitoba,Canada,R3E 0V9 [51]Nova Scotia Health Authority/Qeii Health Sciences Centre,Halifax,Nova Scotia,Canada,B3H 4K4 [52]Princess Margaret Cancer Center,Toronto,Ontario,Canada,MG5 2M9 [53]Peking Union Medical College Hospital,Beijing,China,100032 [54]West China Hospital Sichuan University,Chengdu,China,610041 [55]Fujian Cancer Hospital,Fuzhou,China,350005 [56]Sun Yat-Sen Memorial Hospital Sun Yat-Sen University,Guangdong,China,510000 [57]Sun Yat-Sen Memorial Hospital Sun Yat-Sen University,Guangzhou,China,510000 [58]Shulan Hangzhou Hospital Co Ltd,Hangzhou,China,310000 [59]The Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou,China,310009 [60]Heilongjiang Province Cancer Hospital,Harbin,China,150081 [61]University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital),Hefei,China,230001 [62]Kunming 1St People'S Hospital,Kunming,China,650032 [63]Jiangsu Province Hospital,Nanjing,China,210029 [64]The Affiliated Hospital of Qingdao University,Shandong,China,266071 [65]Zhongshan Hospital Fudan University,Shanghai,China,200032 [66]Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai,China,200092 [67]Xinhua Hospital,SHanghai,China,200092 [68]Sichuan Cancer Hospital,Sichuan,China,610041 [69]Tianjin Medical University Cancer Institute Hospital,Tianjin,China,300060 [70]Tongji Hospital Huazhong University of Science and Technology,Wuhan,China,430030 [71]Hubei Cancer Hospital,Wuhan,China,430079 [72]Northern Jiangsu Peoples Hospital,Yangzhou,China,225001 [73]Herlev Og Gentofte Hospital,Herlev,Denmark,02730 [74]Docrates Cancer Center,Helsinki,Finland,00180 [75]Helsinki University Central Hospital,Helsinki,Finland,00290 [76]Tampere University Hospital,Tampere,Finland,33521 [77]Institut Sainte Catherine,Avignon Cedex 9,France,84918 [78]Chu Besancon Hospital Jean Minjoz,Besancon,France,25030 [79]Institut Bergonie,Bordeaux Cedex,France,33076 [80]Hopital Beaujon,Clichy,France,92110 [81]Hopital Prive Jean Mermoz,Lyon Cedex 08,France,69373 [82]Chu Hopital de La Timone,Marseille Cedex 5,France,13385 [83]Centre Hospitalier Universitaire de Nantes,Nantes,France,44000 [84]Centre Antoine Lacassagne,Nice Cedex 02,France,06189 [85]Hospital Universitaire Pitie-Salpetriere,Paris Cedex 13,France,75013 [86]Hopital Europeen Georges Pompidou (Hegp),Paris Cedex 15,France,75015 [87]Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque,Pessac Cedex,France,336600 [88]Hospital de La Miletrie,Poitiers Cedex,France,86021 [89]Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume,Rouen Cedex,France,76031 [90]University Hospital of Saint Etienne,Saint Etienne,France,42055 [91]Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L''Ouest - Rene Gauducheau,Saint Herblain,France,44800 [92]Chu Toulouse Hopital Rangueil,Toulouse Cedex 9,France,31059 [93]Chu Vandoeuvre-Les-Nancy Hopital Brabois,Vandoeuvre Les Nancy,France,54511 [94]Institut Gustave Roussy,Villejuif Cedex,France,94805 [95]University Medical Center Rwth Aachen,Aachen,Germany,52074 [96]Charite - Campus Virchow-Klinikum,Berlin,Germany,13353 [97]Charite Universitaetsmedizin Berlin - Campus Charite Mitte,Berlin,Germany,13353 [98]Universitatsklinikum Bonn Aoer,Bonn,Germany,53127 [99]Klinikum Bremen-Nord,Bremen,Germany,28755 [100]University Clinic Carl Gustav Carus Technical University Dresden,Dresden,Germany,01307 [101]Klinikum Der Johann Wolfgang Goethe University,Frankfurt,Germany,60590 [102]University Medical Center Freiburg,Freiburg,Germany,79106 [103]Universitatsklinikum Hamburg Eppendorf,Hamburg,Germany,20246 [104]Asklepios Klinik Altona,Hamburg,Germany,22763 [105]Hannover Medical School,Hannover,Germany,30625 [106]Universitaetsklinikum Des Saarlandes,Homburg / Saar,Germany,66421 [107]Universitatsklinikum Koln,Koln,Germany,50937 [108]Universitatsklinikum Leipzig Aor,Leipzig,Germany,04103 [109]Klinikum Ludwigsburg,Ludwigsburg,Germany,71640 [110]OTTO-VON-GUERICKE-UNIVERSIT�T MAGDEBURG,Magdeburg,Germany,39120 [111]Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii,Mainz,Germany,55131 [112]University Hospital Grosshadern Munich,Munich,Germany,81377 [113]Klinikum Nuernberg,Nuernberg,Germany,90419 [114]Universitaetsklinikum in Tubingen,Tubingen,Germany,72076 [115]University Hospital Tuebingen,Tubingen,Germany,72076 [116]UNIVERSIT�TSKLINIKUM ULM,ULM,Germany,89081 [117]St. Vincent''S University Hospital,Dublin 4,Ireland,D04 Y8V0 [118]Soroka University Medical Center,Beer-sheva,Israel,84001 [119]Rambam Health Care Campus,Haifa,Israel,3109601 [120]Hadassah University Hospital,Jerusalem,Israel,9112001 [121]Rabin Medical Center - Beilinson Hospital,Petach Tikva,Israel,4941492 [122]Tel Aviv Sourasky Medical Center,Tel Aviv,Israel,64239 [123]Azienda Ospedaliero Universitaria Ospedali Riuniti,Ancona,Italy,60126 [124]Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari,Bari,Italy,70124 [125]Ospedale Papa Giovanni Xxiii,Bergamo,Italy,24127 [126]L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI,Bologna,Italy,40138 [127]Fondazione Del Piemonte Per L''Oncologia Ircc Candiolo,Candiolo,Italy,10060 [128]Presidio Ospedaliero Garibaldi Nesima,Catania,Italy,95100 [129]Ospedale Degli Infermi - Faenza,Faenza,Italy,48018 [130]Irccs Azienda Ospedaliera Universitaria San Martino,Genova,Italy,16132 [131]Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori,Milano,Italy,20133 [132]Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele,Milan,Italy,20132 [133]European Institute of Oncology,Milan,Italy,20141 [134]Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda,Milan,Italy,20162 [135]A.O.U. Di Modena - Policlinico,Modena,Italy,41124 [136]Istituto Nazionale Tumori Irccs Fondazione Pascale,Napoli,Italy,80131 [137]Universita Degli Studi Della Campania Luigi Vanvitelli U.O.C. Oncologia Medica,Napoli,Italy,80138 [138]Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano,Orbassano,Italy,10043 [139]Iov - Istituto Oncologico Veneto Irccs,Padova,Italy,35128 [140]Presidio Ospedaliero Pescara,Pescara,Italy,65124 [141]Azienda Ospedaliera Universitaria Pisana,Pisa,Italy,56126 [142]Fondazione Policlinico Universitario Agostino Gemelli Irccs,Roma,Italy,00137 [143]Istituto Nazionale Tumori Regina Elena Irccs,Roma,Italy,00144 [144]Universita Campus Bio Medico Di Roma,Rome,Italy,00128 [145]Azienda Ospedaliera San Camillo Forlanini,Rome,Italy,00152 [146]Irccs Istituto Clinico Humanitas,Rozzano,Italy,20089 [147]Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte,Siena,Italy,53100 [148]Centro Ricerche Cliniche Di Verona (Crc),Verona,Italy,37134 [149]San Bartolo Hospital,Vicenza,Italy,36100 [150]Aichi Cancer Center Hospital,Aichi,Japan,464 8681 [151]University of Tokyo Hospital,Bunkyo,Japan,113-8655 [152]Chiba University Hospital,Chiba,Japan,260-8677 [153]Chiba Cancer Center,Chiba,Japan,260-8717 [154]National Hospital Organization Kyushu Cancer Center,Fukuoka-shi,Japan,812-8582 [155]National Hospital Organization Kyushu Cancer Center,Fukuoka,Japan,811-1395 [156]Hiroshima University Hospital,Hiroshima-shi,Japan,734-8551 [157]Hokkaido University Hospital,Hokkaido,Japan,060-8648 [158]Hyogo College of Medicine Hospital,Hyogo,Japan,663-8501 [159]Kanazawa University Hospital,Ishikawa,Japan,920-8641 [160]Teikyo University Hospital,Itabashi-ku,Japan,173-8606 [161]Kobe University Hospital,Kobe,Japan,650-0017 [162]Cancer Institute Hospital of Jfcr,Koto-ku,Japan,135-8550 [163]Kyoto University Hospital,Kyoto-shi,Japan,606-8507 [164]Nho Shikoku Cancer Center,Matsuyama,Japan,791-0280 [165]Kyorin University Hospital,Mitaka,Japan,181-8611 [166]Niigata Cancer Center Hospital,Niigata,Japan,951-8566 [167]Osaka International Cancer Institute,Osaka-shi,Japan,541-8567 [168]Kindai University Hospital,Osakasayama City,Japan,589-8511 [169]Saitama Cancer Center,Saitama,Japan,362-0806 [170]Tohoku University Hospital,Sendai-shi,Japan,980-8574 [171]Keio University Hospital,Shinjuku-ku,Japan,160-8582 [172]Shizuoka Cancer Center,Shizuoka,Japan,411-8777 [173]Osaka University Hospital,Suita-shi,Japan,565-0871 [174]Jichi Medical University Hospital,Tochigi,Japan,329-0498 [175]Toyama University Hospital,Toyama,Japan,930-0194 [176]Yamaguchi University Hospital,UBE,Japan,755-8505 [177]Wakayama Medical University Hospital,Wakayama,Japan,641-8509 [178]Kanagawa Cancer Center,Yokohama-shi,Japan,241-8515 [179]Yokohama City University Medical Center,Yokohama,Japan,232-0024 [180]Oita University Hospital,Yufu-shi,Japan,879-5593 [181]Amsterdam University Medical Centre,Amsterdam,Netherlands,1100 DD [182]Maastricht Umc+,Maastricht,Netherlands,6202 AZ [183]Erasmus Medical Center,Rotterdam,Netherlands,3015 CE [184]Umc Utrecht,Utrecht,Netherlands,3584 CX [185]Oslo University Hospital,Oslo,Norway,00450 [186]Hospital de La Santa Creu I Sant Pau,Barcelona,Spain,08026 [187]Hospital General Universitario Vall D Hebron,Barcelona,Spain,08035 [188]Hospital Clinic I Provincial,Barcelona,Spain,08036 [189]Hospital Clinic de Barcelona,Barcelona,Spain,8036 [190]Hospital Universitario Reina Sofia,Cordoba,Spain,14004 [191]Hospital Universitario Reina Sofia,Córdoba,Spain,14004 [192]Hospital Materno Teresa Herrera,la Coruna,Spain,15006 [193]Hospital General Universitario Gregorio Maranon,Madrid,Spain,28007 [194]Hospital Universitario Ramon Y Cajal,Madrid,Spain,28034 [195]Hospital Universitario Hm Sanchinarro,Madrid,Spain,28050 [196]Hospital Regional Universitario de Malaga,Malaga,Spain,29010 [197]Clinica Universidad de Navarra (Cun),Pamplona,Spain,31008 [198]Hospital Universitari Parc Tauli,Sabadell,Spain,08208 [199]HOSPITAL UNiVERSITARIO DONOSTIA,San Sebastian,Spain,20014 [200]Hospital Universitario Marques de Valdecilla,Santander,Spain,39008 [201]Hospital General Universitario de Valencia,Valencia,Spain,46014 [202]Karolinska Institute Universitetssjukhuset Solna,Solna,Sweden,171 64 [203]Inselspital - Universitaetsspital Bern,Bern,Switzerland,03010 [204]Universitatsspital Zurich,Zuerich,Switzerland,08091 [205]Aberdeen Royal Infirmary,Aberdeen,United Kingdom,AB25 2ZN [206]Addenbrooke''S Hospital,Cambridge,United Kingdom,CB2 0QQ [207]Velindre Cancer Centre,Cardiff,United Kingdom,CF14 2TL [208]University Hospital Coventry and Warwickshire,Coventry,United Kingdom,CV2 2DX [209]The Royal Marsden Nhs Foundation Trust - Chelsea,London,United Kingdom,SW3 6JJ [210]Imperial College Healthcare Nhs Trust - Hammersmith Hospital,London,United Kingdom,W12 0HS [211]University College London Hospitals (Uclh),London,United Kingdom,WC1E 6BT [212]Kent Oncology Centre - Maidstone Hospital,Maidstone,United Kingdom,ME16 9QQ [213]The Christie Nhs Foundation Trust,Manchester,United Kingdom,M20 4BV [214]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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