[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578870":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":143,"collaborators":146,"id":157,"slug":25,"hasResults":158,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":25,"eligibilityCriteria":161,"healthyVolunteers":158,"sex":162,"minAge":163,"maxAge":164,"enrollmentInfo":165,"targetDuration":25,"studyType":168,"phases":169,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},{"fullName":5,"class":6},"Taichung Veterans General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Upfront surgery","ACTIVE_COMPARATOR","Patient in upfront surgery arm will receive operation followed by adjuvant chemotherapy with NALIRIFOX",[13],"Drug: NALIRIFOX",{"label":15,"type":16,"description":17,"interventionNames":18},"Perioperative NALIRIFOX","EXPERIMENTAL","Patient in experimental arm will receive neoadjuvant NALIRIFOX followed by operation than adjuvant NALIRIFOX after operation.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","NALIRIFOX","Patient in upfront surgery arm will receive operation followed by adjuvant chemotherapy with NALIRIFOX; patient in experimental arm will receive neoadjuvant NALIRIFOX followed by operation than adjuvant NALIRIFOX after operation.",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"Yan-Shen Shan, MD, PhD","National Cheng-Kung University Hospital","PRINCIPAL_INVESTIGATOR",[32],{"name":28,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","886-6-2353535","5000","ysshan@mail.ncku.edu.tw",[38,54,64,77,87,97,110,120,130],{"facility":39,"status":40,"city":41,"state":25,"zip":25,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Kaohsiung Chang Gung Memorial Hospital","RECRUITING","Kaohsiung City","Taiwan",{"type":44,"coordinates":45},"Point",[46,47],120.31333,22.61626,{"lat":47,"lon":46},[50],{"name":51,"role":33,"phone":52,"phoneExt":25,"email":53},"Yen-Yang Chen, MD, PhD","886-07-7317123","tnet0901@gmail.com",{"facility":55,"status":40,"city":41,"state":25,"zip":25,"country":42,"cosmosGeoPoint":56,"geoPoint":58,"contacts":59},"Kaohsiung Medical University Chung-Ho Memorial Hospital",{"type":44,"coordinates":57},[46,47],{"lat":47,"lon":46},[60],{"name":61,"role":33,"phone":62,"phoneExt":25,"email":63},"Shih-Chang Chuang","886-07-3121101","chuangsc@cc.kmu.edu.tw",{"facility":65,"status":40,"city":66,"state":25,"zip":25,"country":42,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"China Medical University Hospital","Taichung",{"type":44,"coordinates":68},[69,70],120.6839,24.1469,{"lat":70,"lon":69},[73],{"name":74,"role":33,"phone":75,"phoneExt":25,"email":76},"Li-Yuan Bai, MD, PhD","886-04-22053366","lybai6@gmail.com",{"facility":5,"status":40,"city":66,"state":25,"zip":25,"country":42,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},{"type":44,"coordinates":79},[69,70],{"lat":70,"lon":69},[82],{"name":83,"role":33,"phone":84,"phoneExt":85,"email":86},"Hsin-Chen Lin, MD","886-23592525","3175","jawlin15@hotmail.com",{"facility":88,"status":40,"city":89,"state":25,"zip":25,"country":42,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"National Cheng Kung University Hospital","Tainan",{"type":44,"coordinates":91},[92,93],120.21333,22.99083,{"lat":93,"lon":92},[96],{"name":28,"role":33,"phone":34,"phoneExt":35,"email":36},{"facility":98,"status":40,"city":99,"state":25,"zip":25,"country":42,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"National Taiwan University Hospital","Taipei",{"type":44,"coordinates":101},[102,103],121.52639,25.05306,{"lat":103,"lon":102},[106],{"name":107,"role":33,"phone":108,"phoneExt":25,"email":109},"Ching-Yao Yang, MD, PhD","886-02-23220322","cyang@ntuh.gov.tw",{"facility":111,"status":40,"city":99,"state":25,"zip":25,"country":42,"cosmosGeoPoint":112,"geoPoint":114,"contacts":115},"Taipei Veterans General Hospital",{"type":44,"coordinates":113},[102,103],{"lat":103,"lon":102},[116],{"name":117,"role":33,"phone":118,"phoneExt":25,"email":119},"Nai-Jung Chiang, MD, PhD","886-02-28749425","njchiang@vghtpe.gov.tw",{"facility":121,"status":40,"city":99,"state":25,"zip":25,"country":42,"cosmosGeoPoint":122,"geoPoint":124,"contacts":125},"Tri-Service General Hospital",{"type":44,"coordinates":123},[102,103],{"lat":103,"lon":102},[126],{"name":127,"role":33,"phone":128,"phoneExt":25,"email":129},"Shiue-Wei Lai","886-02-87923311","xsurfer@mail.ndmctsgh.edu.tw",{"facility":131,"status":40,"city":132,"state":25,"zip":25,"country":42,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Linkou Chang Gung Memorial Hospital","Taoyuan",{"type":44,"coordinates":134},[135,136],121.29696,24.99368,{"lat":136,"lon":135},[139],{"name":140,"role":33,"phone":141,"phoneExt":25,"email":142},"Chun-Nan Yeh","886-03-3281200","ycn@cgmh.org.tw",{"type":30,"investigatorFullName":144,"investigatorTitle":145,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Hsin-Chen Lin","Medical Doctor",[147,148,150,153,154,155,156],{"name":29,"class":6},{"name":149,"class":6},"Chang Gung Memorial Hospital",{"name":151,"class":152},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",{"name":98,"class":6},{"name":65,"class":6},{"name":55,"class":6},{"name":121,"class":6},"100578870",false,"NCT06816914","Perioperative NALIRIFOX (liposomal Irinotecan in Combination with Fluorouracil, Leucovorin, and Oxaliplatin) in Resectable Pancreatic Adenocarcinoma: Randomized Phase II Trial","Inclusion Criteria:\n\n* previously untreated, histologically or cytologically proven PDAC\n* age between 20 and 75 years at registration\n* ECOG performance status of 0 or 1\n* AJCC (8th edition) clinical stage I or II with measurable disease (CT or MRI) in the pancreas. (positron emission tomography scan alone not allowed)\n* Surgically resectable disease according to NCCN criteria (Version 1.2023 - May 4, 2023):\n* no arterial tumor contact (celiac axis, superior mesentery artery, or common hepatic artery).\n* no tumor contact with the superior mesentery vein or portal vein or ≤180° contact without vein contour irregularity.\n* adequate major organ functions\n* Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons) must agree to use contraception from the time ofinformed consent until 6 months or more after the last dose of investigational products. Also, women must agree not to breastfeed from the time of informed consent until 6 months or more after the last dose of the investigational product.\n* Men must agree to use contraception from the start of study treatment until 3 months or more after the last dose of the investigational product.\n* Participants must have signed written informed consent form in accordance with regulatory and institutional guidelines.\n\nExclusion Criteria:\n\n* presence of clinically significant co-morbid medical conditions within 4 weeks prior registration judged by Investigators\n* severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in past 6 months\n* New York Heart Association class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure or known abnormal electrocardiogram (ECG) with clinically significant abnormal findings in past 6 months\n* interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity within 28 days prior to registration\n* presence of diarrhea ≥ CTCAE v.5.0 grade 2\n* concomitant systemic infection requiring treatment\n* prior organ allograft or allogeneic bone marrow transplantation\n* known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome\n* prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer\n* any major surgery within 4 weeks of study treatment. Participants must have recovered from the effects of major surgery or significant traumatic injury at least 4 weeks before study treatment.\n* pregnant women or nursing mothers, or positive pregnancy tests\n* severe mental disorder\n* current use or any use in past 2 weeks of strong cytochrome P450 3A4 enzyme inducers\u002Finhibitors and\u002For strong UGT1A inhibitors\n* known hypersensitivity to any of the components of study drugs","ALL","20 Years","75 Years",{"count":166,"type":167},84,"ESTIMATED","INTERVENTIONAL",[170],"PHASE2","To explore the safety and activity of NALIRIFOX (liposomal irinotecan in combination with fluorouracil, leucovorin, and oxaliplatin) in the perioperative and adjuvant treatment in resectable pancreatic adeneocarcinoma.",[173],"Resectable Pancreatic Adenocarcinoma",[175,22,176],"Perioperative","resectable pancreatic adenocarcinoma","2025-02-18",{"date":179,"type":180},"2025-02-20","ACTUAL",{"date":182,"type":167},"2025-03-05",{"date":184,"type":167},"2028-02-05",{"name":5,"class":6},9]