[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647693":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":42,"centralContacts":55,"locations":61,"responsibleParty":214,"collaborators":216,"id":219,"slug":220,"hasResults":221,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":221,"sex":227,"minAge":228,"maxAge":42,"enrollmentInfo":229,"targetDuration":42,"studyType":232,"phases":233,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":106,"whyStopped":42,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":252},{"fullName":5,"class":6},"Taiho Pharmaceutical Co., Ltd.","INDUSTRY",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm","EXPERIMENTAL","Futibatinib + Zimberelimab + Gemcitabine + Cisplatin",[13,14,15,16],"Drug: Futibatinib","Drug: Zimberelimab","Drug: Gemcitabine","Drug: Cisplatin",{"label":18,"type":19,"description":20,"interventionNames":21},"Control Arm","ACTIVE_COMPARATOR","Investigator's choice; Durvalumab or Pembrolizumab + Gemcitabine + Cisplatin",[22,23,15,16],"Drug: Durvalumab","Drug: Pembrolizumab",[25,32,38,43,47,51],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Futibatinib","Futibatinib 20 mg will be administered orally once daily.",[9],[31],"TAS-120",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Zimberelimab","Zimberelimab 360 mg will be administered on Day 1 of each 3-week cycle (Q3W) by intravenous infusion.",[9],[37],"AB122",{"type":26,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Durvalumab","Durvalumab 1500 mg will be administered on Day 1 of Q3W by intravenous infusion.",[18],null,{"type":26,"name":44,"description":45,"armGroupLabels":46,"otherNames":42},"Pembrolizumab","Pembrolizumab 200 mg will be administered on Day 1 of Q3W by intravenous infusion.",[18],{"type":26,"name":48,"description":49,"armGroupLabels":50,"otherNames":42},"Gemcitabine","Gemcitabine 1000 mg\u002Fm2 will be administered Days 1 and 8 of Q3W by intravenous infusion.",[18,9],{"type":26,"name":52,"description":53,"armGroupLabels":54,"otherNames":42},"Cisplatin","Cisplatin 25 mg\u002Fm2 will be administered Days 1 and 8 of Q3W by intravenous infusion.",[18,9],[56],{"name":57,"role":58,"phone":59,"phoneExt":42,"email":60},"Kotaro Suto","CONTACT","+81-3-3294-4527","th-FOENIX-BTC-Clin.Dev@taiho.co.jp",[62,74,81,88,95,104,113,117,119,127,134,141,148,153,161,169,177,184,191,198,207],{"facility":63,"status":64,"city":65,"state":42,"zip":42,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":42},"Research Site","NOT_YET_RECRUITING","Brisbane","Australia","AU",{"type":69,"coordinates":70},"Point",[71,72],153.02809,-27.46794,{"lat":72,"lon":71},{"facility":63,"status":64,"city":75,"state":42,"zip":42,"country":66,"countryCode":67,"cosmosGeoPoint":76,"geoPoint":80,"contacts":42},"Melbourne",{"type":69,"coordinates":77},[78,79],144.96332,-37.814,{"lat":79,"lon":78},{"facility":63,"status":64,"city":82,"state":42,"zip":42,"country":66,"countryCode":67,"cosmosGeoPoint":83,"geoPoint":87,"contacts":42},"Perth",{"type":69,"coordinates":84},[85,86],115.8614,-31.95224,{"lat":86,"lon":85},{"facility":63,"status":64,"city":89,"state":42,"zip":42,"country":66,"countryCode":67,"cosmosGeoPoint":90,"geoPoint":94,"contacts":42},"Sydney",{"type":69,"coordinates":91},[92,93],151.20732,-33.86785,{"lat":93,"lon":92},{"facility":63,"status":64,"city":96,"state":42,"zip":42,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":103,"contacts":42},"Aichi","Japan","JP",{"type":69,"coordinates":100},[101,102],130.62158,32.51879,{"lat":102,"lon":101},{"facility":105,"status":106,"city":107,"state":42,"zip":42,"country":97,"countryCode":98,"cosmosGeoPoint":108,"geoPoint":112,"contacts":42},"National Hospital Organization Kyushu Cancer Center","RECRUITING","Fukuoka",{"type":69,"coordinates":109},[110,111],130.41667,33.6,{"lat":111,"lon":110},{"facility":63,"status":64,"city":107,"state":42,"zip":42,"country":97,"countryCode":98,"cosmosGeoPoint":114,"geoPoint":116,"contacts":42},{"type":69,"coordinates":115},[110,111],{"lat":111,"lon":110},{"facility":63,"status":64,"city":118,"state":42,"zip":42,"country":97,"countryCode":98,"cosmosGeoPoint":42,"geoPoint":42,"contacts":42},"Hokkaido",{"facility":120,"status":64,"city":121,"state":42,"zip":42,"country":97,"countryCode":98,"cosmosGeoPoint":122,"geoPoint":126,"contacts":42},"Kanagawa Cancer Center","Kanagawa",{"type":69,"coordinates":123},[124,125],139.91667,37.58333,{"lat":125,"lon":124},{"facility":63,"status":64,"city":128,"state":42,"zip":42,"country":97,"countryCode":98,"cosmosGeoPoint":129,"geoPoint":133,"contacts":42},"Miyagi",{"type":69,"coordinates":130},[131,132],128.18236,26.62566,{"lat":132,"lon":131},{"facility":63,"status":64,"city":135,"state":42,"zip":42,"country":97,"countryCode":98,"cosmosGeoPoint":136,"geoPoint":140,"contacts":42},"Osaka",{"type":69,"coordinates":137},[138,139],135.50107,34.69379,{"lat":139,"lon":138},{"facility":63,"status":64,"city":142,"state":42,"zip":42,"country":97,"countryCode":98,"cosmosGeoPoint":143,"geoPoint":147,"contacts":42},"Tokyo",{"type":69,"coordinates":144},[145,146],139.69171,35.6895,{"lat":146,"lon":145},{"facility":149,"status":106,"city":142,"state":42,"zip":42,"country":97,"countryCode":98,"cosmosGeoPoint":150,"geoPoint":152,"contacts":42},"The Cancer Institute Hospital",{"type":69,"coordinates":151},[145,146],{"lat":146,"lon":145},{"facility":154,"status":106,"city":155,"state":42,"zip":42,"country":97,"countryCode":98,"cosmosGeoPoint":156,"geoPoint":160,"contacts":42},"Toyama University Hopspital","Toyama",{"type":69,"coordinates":157},[158,159],137.21667,36.7,{"lat":159,"lon":158},{"facility":162,"status":106,"city":163,"state":42,"zip":42,"country":97,"countryCode":98,"cosmosGeoPoint":164,"geoPoint":168,"contacts":42},"Wakayama Medical University Hospital","Wakayama",{"type":69,"coordinates":165},[166,167],135.16667,34.23333,{"lat":167,"lon":166},{"facility":63,"status":64,"city":170,"state":42,"zip":42,"country":171,"countryCode":42,"cosmosGeoPoint":172,"geoPoint":176,"contacts":42},"Busan","South Korea",{"type":69,"coordinates":173},[174,175],129.03004,35.10168,{"lat":175,"lon":174},{"facility":63,"status":64,"city":178,"state":42,"zip":42,"country":171,"countryCode":42,"cosmosGeoPoint":179,"geoPoint":183,"contacts":42},"Hwasun",{"type":69,"coordinates":180},[181,182],126.98746,35.06125,{"lat":182,"lon":181},{"facility":63,"status":64,"city":185,"state":42,"zip":42,"country":171,"countryCode":42,"cosmosGeoPoint":186,"geoPoint":190,"contacts":42},"Seongnam",{"type":69,"coordinates":187},[188,189],127.7548,36.4052,{"lat":189,"lon":188},{"facility":63,"status":64,"city":192,"state":42,"zip":42,"country":171,"countryCode":42,"cosmosGeoPoint":193,"geoPoint":197,"contacts":42},"Seoul",{"type":69,"coordinates":194},[195,196],126.9784,37.566,{"lat":196,"lon":195},{"facility":63,"status":64,"city":199,"state":42,"zip":42,"country":200,"countryCode":201,"cosmosGeoPoint":202,"geoPoint":206,"contacts":42},"Bangkok","Thailand","TH",{"type":69,"coordinates":203},[204,205],100.50144,13.75398,{"lat":205,"lon":204},{"facility":63,"status":64,"city":208,"state":42,"zip":42,"country":200,"countryCode":201,"cosmosGeoPoint":209,"geoPoint":213,"contacts":42},"Chiang Mai",{"type":69,"coordinates":210},[211,212],98.98468,18.79038,{"lat":212,"lon":211},{"type":215,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[217],{"name":218,"class":6},"Taiho Oncology, Inc.","100647693","phase-3-futibatinib-tas-120-in-patients-with-advanced-biliary-tract-cancer-100647693",false,"NCT07710885","Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer","A Phase 3, Randomized-Controlled, Open-Label, Multi-Regional, International Study of Futibatinib (TAS-120) and Zimberelimab (AB122) in Combination With Gemcitabine Plus Cisplatin Versus Durvalumab or Pembrolizumab in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers","FOENIX-BTC","Inclusion Criteria:\n\n1. Has histologically confirmed unresectable or advanced biliary tract (i.e. intrahepatic bile duct, extrahepatic bile duct, or gallbladder) cancer that is adenocarcinoma or adenosquamous carcinoma;\n2. Has no history of prior treatment for locally advanced or metastatic Biliary Tract Cancer (BTC);\n\n   * Adjuvant or neoadjuvant chemotherapy is not considered as prior treatment if more than 6 months have passed since its completion.\n3. Has radiographically measurable disease per RECIST v1.1.\n4. Has a tumor tissue sample available for biomarker analysis in a quantity sufficient.\n5. Has an ECOG PS of 0 or 1 before administration of study treatment; Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria.\n\nExclusion Criteria:\n\n1. History and\u002For current evidence of clinically significant nontumor-related alteration of calcium-phosphorus homeostasis;\n2. History and\u002For current evidence of clinically significant retinal disorder confirmed by retinal examination;\n3. Has prior Fibroblast Growth Factor Receptor (FGFR)-directed therapy including futibatinib\n4. Has prior treatment with an anti-Programmed Death Ligand 1 (PD-L1), anti-Programmed Cell Death Protein 1 (PD-1), anti-Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4), anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT), or other immune checkpoint inhibitor (ICI) or agonist as monotherapy or in combination.\n\nHas known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.","ALL","18 Years",{"count":230,"type":231},784,"ESTIMATED","INTERVENTIONAL",[234],"PHASE3","To compare overall survival (OS) of patients in Futibatinib and Zimberelimab in Combination with Gemcitabine plus Cisplatin versus Durvalumab or Pembrolizumab in Combination with Gemcitabine plus Cisplatin for patients with first-line advanced biliary tract cancer",[237],"Biliary Tract Cancer",[27,239,31,33,37,48,52,39,44,240,241,242],"Biliary Tract Cancer (BTC)","Phase 3","Fibroblast Growth Factor Receptor (FGFR)","Programmed Cell Death Protein 1 (PD-1)","2026-07-13",{"date":245,"type":246},"2026-07-17","ACTUAL",{"date":248,"type":246},"2026-06-24",{"date":250,"type":231},"2031-12-31",{"name":5,"class":6},21]