[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578870":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":144,"collaborators":147,"id":158,"slug":25,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":161,"acronym":25,"eligibilityCriteria":162,"healthyVolunteers":159,"sex":163,"minAge":164,"maxAge":165,"enrollmentInfo":166,"targetDuration":25,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"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",[38,55,65,78,88,98,111,121,131],{"facility":39,"status":40,"city":41,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Kaohsiung Chang Gung Memorial Hospital","RECRUITING","Kaohsiung City","Taiwan","TW",{"type":45,"coordinates":46},"Point",[47,48],120.31333,22.61626,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":53,"phoneExt":25,"email":54},"Yen-Yang Chen, MD, PhD","886-07-7317123","tnet0901@gmail.com",{"facility":56,"status":40,"city":41,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},"Kaohsiung Medical University Chung-Ho Memorial Hospital",{"type":45,"coordinates":58},[47,48],{"lat":48,"lon":47},[61],{"name":62,"role":33,"phone":63,"phoneExt":25,"email":64},"Shih-Chang Chuang","886-07-3121101","chuangsc@cc.kmu.edu.tw",{"facility":66,"status":40,"city":67,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"China Medical University Hospital","Taichung",{"type":45,"coordinates":69},[70,71],120.6839,24.1469,{"lat":71,"lon":70},[74],{"name":75,"role":33,"phone":76,"phoneExt":25,"email":77},"Li-Yuan Bai, MD, PhD","886-04-22053366","lybai6@gmail.com",{"facility":5,"status":40,"city":67,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":79,"geoPoint":81,"contacts":82},{"type":45,"coordinates":80},[70,71],{"lat":71,"lon":70},[83],{"name":84,"role":33,"phone":85,"phoneExt":86,"email":87},"Hsin-Chen Lin, MD","886-23592525","3175","jawlin15@hotmail.com",{"facility":89,"status":40,"city":90,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"National Cheng Kung University Hospital","Tainan",{"type":45,"coordinates":92},[93,94],120.21333,22.99083,{"lat":94,"lon":93},[97],{"name":28,"role":33,"phone":34,"phoneExt":35,"email":36},{"facility":99,"status":40,"city":100,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"National Taiwan University Hospital","Taipei",{"type":45,"coordinates":102},[103,104],121.52639,25.05306,{"lat":104,"lon":103},[107],{"name":108,"role":33,"phone":109,"phoneExt":25,"email":110},"Ching-Yao Yang, MD, PhD","886-02-23220322","cyang@ntuh.gov.tw",{"facility":112,"status":40,"city":100,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":113,"geoPoint":115,"contacts":116},"Taipei Veterans General Hospital",{"type":45,"coordinates":114},[103,104],{"lat":104,"lon":103},[117],{"name":118,"role":33,"phone":119,"phoneExt":25,"email":120},"Nai-Jung Chiang, MD, PhD","886-02-28749425","njchiang@vghtpe.gov.tw",{"facility":122,"status":40,"city":100,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":123,"geoPoint":125,"contacts":126},"Tri-Service General Hospital",{"type":45,"coordinates":124},[103,104],{"lat":104,"lon":103},[127],{"name":128,"role":33,"phone":129,"phoneExt":25,"email":130},"Shiue-Wei Lai","886-02-87923311","xsurfer@mail.ndmctsgh.edu.tw",{"facility":132,"status":40,"city":133,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Linkou Chang Gung Memorial Hospital","Taoyuan",{"type":45,"coordinates":135},[136,137],121.29696,24.99368,{"lat":137,"lon":136},[140],{"name":141,"role":33,"phone":142,"phoneExt":25,"email":143},"Chun-Nan Yeh","886-03-3281200","ycn@cgmh.org.tw",{"type":30,"investigatorFullName":145,"investigatorTitle":146,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Hsin-Chen Lin","Medical Doctor",[148,149,151,154,155,156,157],{"name":29,"class":6},{"name":150,"class":6},"Chang Gung Memorial Hospital",{"name":152,"class":153},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",{"name":99,"class":6},{"name":66,"class":6},{"name":56,"class":6},{"name":122,"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":167,"type":168},84,"ESTIMATED","INTERVENTIONAL",[171],"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.",[174],"Resectable Pancreatic Adenocarcinoma",[176,22,177],"Perioperative","resectable pancreatic adenocarcinoma","2025-02-18",{"date":180,"type":181},"2025-02-20","ACTUAL",{"date":183,"type":168},"2025-03-05",{"date":185,"type":168},"2028-02-05",{"name":5,"class":6},9]