[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598801":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":53,"centralContacts":57,"locations":63,"responsibleParty":89,"collaborators":11,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":11,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":11,"enrollmentInfo":100,"targetDuration":11,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":11,"overallStatus":66,"whyStopped":11,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Medical University of South Carolina","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"NALIRIFOX","EXPERIMENTAL",null,[13,14,15,16],"Drug: Liposomal Irinotecan","Drug: Oxaliplatin","Drug: 5-Fluorouracil","Drug: Leucovorin",{"label":18,"type":10,"description":11,"interventionNames":19},"mGAP",[20,21,22],"Drug: Gemcitabine (mg\u002Fm²)","Drug: Nab-paclitaxel","Drug: Cisplatin",[24,29,33,37,41,45,49],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"DRUG","Liposomal Irinotecan","50 mg\u002Fm2 will be administered on Day 1 of a 2-week cycle",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"Oxaliplatin","60 mg\u002Fm2 will be administered on Day 1 of a 2-week cycle",[9],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"5-Fluorouracil","5-fluorouracil (2400 mg\u002Fm2 over 46 hours) will begin administration on Day 1 of a 2-week cycle",[9],{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":11},"Leucovorin","400 mg\u002Fm2 will be administered on Day 1 of a 2-week cycle",[9],{"type":25,"name":42,"description":43,"armGroupLabels":44,"otherNames":11},"Gemcitabine (mg\u002Fm²)","1000 mg\u002Fm2 will be administered on Day 1 and Day 15 of a 4-week cycle",[18],{"type":25,"name":46,"description":47,"armGroupLabels":48,"otherNames":11},"Nab-paclitaxel","125 mg\u002Fm2 will be administered on Day 1 and Day 15 of a 4-week cycle",[18],{"type":25,"name":50,"description":51,"armGroupLabels":52,"otherNames":11},"Cisplatin","25 mg\u002Fm2 will be administered on Day 1 and Day 15 of a 4-week cycle",[18],[54],{"name":55,"affiliation":5,"role":56},"Albert Lockhart, MD","PRINCIPAL_INVESTIGATOR",[58],{"name":59,"role":60,"phone":61,"phoneExt":11,"email":62},"HCC Clinical Trials Office, MD","CONTACT","843-792-9321","hcc-clinical-trials@musc.edu",[64,82],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Hollings Cancer Center at Medical University of South Carolina","RECRUITING","Charleston","South Carolina","29425","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-79.93275,32.77632,{"lat":76,"lon":75},[79,81],{"name":80,"role":60,"phone":61,"phoneExt":11,"email":62},"HCC Clinical Trials Office",{"name":55,"role":56,"phone":11,"phoneExt":11,"email":11},{"facility":83,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"Medical University of South Carolina Hollings Cancer Center",{"type":73,"coordinates":85},[75,76],{"lat":76,"lon":75},[88],{"name":80,"role":60,"phone":61,"phoneExt":11,"email":62},{"type":90,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100598801","phase-2-evaluating-nalirifox-vs-modified-gemcitabine-nab-paclitaxel-and-cisplatin-in-patients-with-locally-advanced-and-metastatic-pancreatic-adenocarcinoma-100598801",false,"NCT07076212","Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma","Phase II Study Evaluating NALIRIFOX Versus Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged ≥18 years\n* For females of reproductive potential: use of highly effective contraception for at least 1 month before screening and agreement to use such a method during study participation and for an additional 9 months after the end of the last dose of study medication administration\n* Female patients including WOCBP must test negative for pregnancy at the time of screening based on a urine or serum pregnancy test.\n* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with a partner during the study and for 4 months after the last dose of study medication.\n* Histologically or cytologically confirmed locally advanced or metastatic PDAC that has not been previously treated\n* Radiographically confirmed measurable (per RECIST 1.1) locally advanced or metastatic PDAC per the National Comprehensive Cancer Network (NCCN) definition.\n* Inoperable status due to the presence of locally advanced, unresectable disease with or metastases.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Hematological, biochemical, and organ function inclusion criteria:\n\n  * Absolute neutrophil count (ANC) ≥1500\u002Fmm3 without the use of hemopoietic growth factors within 7 days before treatment\n  * Platelet count ≥100,000\u002Fmm3.\n  * International normalized ratio (INR) \\\u003C1.5 unless the patient is receiving anticoagulation therapy, in which case a therapeutic INR is acceptable. Anticoagulation therapy with low-molecular weight heparin or warfarin, whether medically indicated, is permitted.\n  * Adequate renal function, as evidenced by serum\u002Fplasma creatinine level \\\u003C1.6 mg\u002FdL\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Treatment with another investigational drug or other intervention within 30 days of protocol initiation.\n* Known hypersensitivity\u002Fallergic reaction to any of the components of the therapeutic agents in mGAP or NALIRIFOX.\n* Any other medical or social condition deemed by the investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate, and participate in the study or who is likely to interfere with the interpretation of the results.\n* Unwilling or unable to comply with study procedures and\u002For study visits.\n* Uncontrolled, active infection\n* Histologic diagnosis other than adenocarcinoma.\n* Medical co-morbidities, that preclude major abdominal surgery","ALL","18 Years",{"count":101,"type":102},52,"ESTIMATED","INTERVENTIONAL",[105],"PHASE2","This is a single-center, open-label, randomized Phase 2 trial to evaluate the efficacy of NALIRIFOX (Arm 1) vs mGAP (Arm 2) in previously untreated patients with locally advanced (unresectable) and metastatic pancreatic ductal adenocarcinoma (PDAC).",[108,109],"Metastatic Pancreatic Adenocarcinoma","Locally Advanced Pancreatic Adenocarcinoma","2026-05-04",{"date":112,"type":113},"2026-05-06","ACTUAL",{"date":115,"type":113},"2026-04-02",{"date":117,"type":102},"2029-11",{"name":5,"class":6},2]