[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579261":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":174,"centralContacts":178,"locations":179,"responsibleParty":200,"collaborators":178,"id":202,"slug":203,"hasResults":204,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":178,"eligibilityCriteria":208,"healthyVolunteers":204,"sex":209,"minAge":210,"maxAge":178,"enrollmentInfo":211,"targetDuration":178,"studyType":214,"phases":215,"briefSummary":217,"conditions":218,"keywords":178,"overallStatus":181,"whyStopped":178,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":229},{"fullName":5,"class":6},"Roswell Park Cancer Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (NALIRIFOX)","EXPERIMENTAL","Patients receive liposomal irinotecan IV over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin IV over 30 minutes and fluorouracil IV over 48 hours on day 1 of each cycle. Cycles repeat every 14 days for 4-8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgical resection 4-8 weeks after the last treatment dose. Starting 4-12 weeks after surgery, patients receive liposomal irinotecan, oxaliplatin, leucovorin, and fluorouracil for up to 4 additional cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT and blood sample collection throughout the study.",[13,14,15,16,17,18,19],"Procedure: Biospecimen Collection","Procedure: Computed Tomography","Drug: Fluorouracil","Drug: Irinotecan Sucrosofate","Drug: Leucovorin Calcium","Drug: Oxaliplatin","Procedure: Surgical Procedure",[21,30,45,71,90,136,160],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9],[27,28,29],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Computed Tomography","Undergo CT",[9],[35,36,37,38,39,40,41,42,43,44],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","tomography",{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"DRUG","Fluorouracil","Given IV",[9],[51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70],"5 Fluorouracil","5 Fluorouracilum","5 FU","5-Fluoro-2,4(1H, 3H)-pyrimidinedione","5-Fluorouracil","5-Fluracil","5-Fu","5FU","AccuSite","Carac","Fluoro Uracil","Fluouracil","Flurablastin","Fluracedyl","Fluracil","Fluril","Fluroblastin","Ribofluor","Ro 2-9757","Ro-2-9757",{"type":46,"name":72,"description":48,"armGroupLabels":73,"otherNames":74},"Irinotecan Sucrosofate",[9],[75,76,77,78,79,80,81,82,83,84,85,86,87,88,89],"inotecan Hydrochloride as Sucrosulfate Salt Form Liposomal Formulation","Irinotecan Liposome","Irinotecan Sucrosofate Liposome","Irinotecan Sucrosofate-containing Pegylated Liposomal Formulation","MM 398","MM-398","MM398","nal-IRI","Nanoliposomal Irinotecan","Nanoliposomal Irinotecan as Sucrosofate","Nanoparticle Liposome Formulation of Irinotecan","Onivyde","PEP 02","PEP-02","PEP02",{"type":46,"name":91,"description":48,"armGroupLabels":92,"otherNames":93},"Leucovorin Calcium",[9],[94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135],"Adinepar","Calcifolin","Calcium (6S)-Folinate","Calcium Folinate","Calcium Leucovorin","Calfolex","Calinat","Cehafolin","Citofolin","Citrec","Citrovorum Factor","Cromatonbic Folinico","Dalisol","Disintox","Divical","Ecofol","Emovis","Factor, Citrovorum","Flynoken A","Folaren","Folaxin","FOLI-cell","Foliben","Folidan","Folidar","Folinac","Folinate Calcium","folinic acid","Folinic Acid Calcium Salt Pentahydrate","Folinoral","Folinvit","Foliplus","Folix","Imo","Lederfolat","Lederfolin","Leucosar","leucovorin","Rescufolin","Rescuvolin","Tonofolin","Wellcovorin",{"type":46,"name":137,"description":48,"armGroupLabels":138,"otherNames":139},"Oxaliplatin",[9],[140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159],"1-OHP","Ai Heng","Aiheng","Dacotin","Dacplat","Diaminocyclohexane Oxalatoplatinum","Eloxatin","Eloxatine","Elplat","JM 83","JM-83","JM83","Oxalatoplatin","Oxalatoplatinum","RP 54780","RP-54780","RP54780","SR 96669","SR-96669","SR96669",{"type":22,"name":161,"description":162,"armGroupLabels":163,"otherNames":164},"Surgical Procedure","Undergo surgical resection",[9],[165,166,167,168,169,170,171,172,173],"Operation","Surgery","Surgery Type","Surgery, NOS","Surgical","Surgical Intervention","Surgical Interventions","Surgical Procedures","Type of Surgery",[175],{"name":176,"affiliation":5,"role":177},"Christos Fountzilas","PRINCIPAL_INVESTIGATOR",null,[180],{"facility":5,"status":181,"city":182,"state":183,"zip":184,"country":185,"countryCode":186,"cosmosGeoPoint":187,"geoPoint":192,"contacts":193},"RECRUITING","Buffalo","New York","14263","United States","US",{"type":188,"coordinates":189},"Point",[190,191],-78.87837,42.88645,{"lat":191,"lon":190},[194,199],{"name":195,"role":196,"phone":197,"phoneExt":178,"email":198},"Ask RPCI","CONTACT","877-275-7724","askrpci@roswellpark.org",{"name":176,"role":177,"phone":178,"phoneExt":178,"email":178},{"type":201,"investigatorFullName":178,"investigatorTitle":178,"investigatorAffiliation":178,"oldNameTitle":178,"oldOrganization":178},"SPONSOR","100579261","phase-2-nalirifox-before-surgery-for-the-treatment-of-borderline-resectable-pancreatic-ductal-adenocarcinoma-nectar-trial-100579261",false,"NCT06821997","NALIRIFOX Before Surgery for the Treatment of Borderline Resectable Pancreatic Ductal Adenocarcinoma, Nectar Trial","A Phase 2 Clinical Trial of Nalirifox as Neoadjuvant Treatment for Patients With Borderline Resectable Pancreatic Ductal Adenocarcinoma (Nectar Study)","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Have histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) that is borderline resectable (BR) using the National Comprehensive Cancer Network criteria\n* Have a documented Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002FuL without the use of hematopoietic growth factors\n* Platelet count ≥ 100,000 cells\u002FuL\n* Hemoglobin ≥ 9 g\u002FdL\n* Plasma total bilirubin ≤ upper limit of normal (ULN) (biliary drainage is allowed for biliary obstruction)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Creatine clearance of \\> 30 mL\u002Fmin (per Cockroft-Gault equation)\n* Plasma albumin ≥ 3 g\u002FdL\n* Have measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Participant must understand the investigational nature of this study and sign an independent ethics committee\u002Finstitutional review board approved written informed consent form (ICF) prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Patients who have had previous chemotherapy or radiotherapy for PDAC\n* Patients with resectable, unresectable, or metastatic PDAC\n* Presence of germline glucuronosyltransferase (UGT) 1A1 (\\*28 or \\*6) or dihydropyrimidine dehydrogenase (DPD) polymorphisms (DPYD\\*2A \\[rs3918290, c.1905+1G\\>A, IVS14+1G\\>A\\], c.2846A\\>T \\[rs67376798, D949V\\], c.1679T\\>G \\[rs55886062, DPYD\\*13, I560S\\], and c.1236G\\>A \\[rs56038477, E412E, in haplotype B3\\]) known to significantly impact CPT-11 and fluorouracil metabolism and associated with increased risk for toxicities\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant or nursing female participants\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug","ALL","18 Years",{"count":212,"type":213},20,"ESTIMATED","INTERVENTIONAL",[216],"PHASE2","This phase II trial tests how well liposomal irinotecan, oxaliplatin, 5-fluorouracil and leucovorin (NALIRIFOX) before surgery works in treating patients with pancreatic ductal adenocarcinoma that is close to major blood vessels, but is still potentially removable by surgery (borderline resectable). Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Liposomal irinotecan is a form of the anticancer drug irinotecan that is contained inside very tiny, fat-like particles. Liposomal irinotecan may have fewer side effects and work better than other forms of the drug. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. 5-fluorouracil, a type of antimetabolite, stops cells from making DNA and it may kill tumor cells. Leucovorin, a form of folic acid, is used to lessen the toxic effects of substances that block the action of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Giving NALIRIFOX before surgery may improve the chance of successful surgery and decrease the chance of the cancer returning after surgery in patients with borderline resectable pancreatic ductal adenocarcinoma.",[219],"Borderline Resectable Pancreatic Ductal Adenocarcinoma","2026-03-31",{"date":222,"type":223},"2026-04-01","ACTUAL",{"date":225,"type":223},"2026-03-02",{"date":227,"type":213},"2027-03-01",{"name":5,"class":6},1]