[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560001":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":46,"locations":29,"responsibleParty":52,"collaborators":29,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":29,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":29,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":29,"overallStatus":73,"whyStopped":29,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":29},{"fullName":5,"class":6},"CSPC Ouyi Pharmaceutical Co., Ltd.","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"NASOX：Liposomal Irinotecan; Oxaliplatin; S-1","EXPERIMENTAL","Liposomal irinotecan at a dose of 50 mg\u002Fm² is administered intravenously over 90 minutes on D1. Oxaliplatin is administered at a dose of 60 mg\u002Fm² intravenously over 2 hours on D1. S-1 at a dose of 40 to 60mg twice daily is taken orally for 7 consecutive days, followed by a 7-day break. These medications are administered once every 2 weeks for a total of 12 cycles.",[13,14,15],"Drug: Liposomal Irinotecan","Drug: Oxaliplatin","Drug: S-1",{"label":17,"type":18,"description":19,"interventionNames":20},"GX：Gemcitabine; Capecitabine","ACTIVE_COMPARATOR","Gemcitabine at a dose of 1000mg\u002Fm² is administered via intravenous infusion over 30 minutes on D1, 8, and 15 of a 28-day cycle. Capecitabine at a dose of 1660mg\u002Fm² per day in two divided oral doses is taken for 21 consecutive days, followed by a 7-day rest period. These medications are administered once every 4 weeks for a total of 6 cycles.",[21,22],"Drug: Gemcitabine","Drug: Capecitabine",[24,30,34,38,42],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Liposomal Irinotecan","Liposomal Irinotecan：i.v. infusion",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Oxaliplatin","Oxaliplatin;：i.v. infusion",[9],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"S-1","S-1: Oral",[9],{"type":25,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"Gemcitabine","Gemcitabine: i.v. infusion",[17],{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":29},"Capecitabine","Capecitabine: Oral",[17],[47],{"name":48,"role":49,"phone":50,"phoneExt":29,"email":51},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",{"type":53,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100560001","phase-3-liposomal-irinotecan-in-combination-with-oxaliplatin-and-s-1-versus-gemcitabine-combined-with-capecitabine-as-postoperative-adjuvant-therapy-for-pancreatic-cancer-100560001",false,"NCT06571461","Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer","A Randomized, Open-label, Multi-center Phase III Clinical Study of Liposomal Irinotecan Combined With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine for Postoperative Adjuvant Treatment of Pancreatic Cancer","Inclusion Criteria:\n\n1. Patients able and willing to provide a written informed consent aged 18-75 years.\n2. Histologically confirmed resected ductal pancreatic adenocarcinoma (including adenosquamous carcinoma).\n3. Undergone radical resection and confirmed macroscopic complete resection (R0 and R1).\n4. Full recovery after surgery; able to start adjuvant treatment within 12 weeks after surgery.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n6. The main organs function well.\n\nExclusion Criteria:\n\n1. Patients with other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, pancreatoblastoma, and solid-pseudopapillary tumor.\n2. Macroscopic incomplete tumor removal (R2 resection).\n3. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.\n4. Presence or history of metastatic or locally recurrent pancreatic adenocarcinoma.\n5. CA 19-9\\> 180 U \u002F ml within 21 days before randomization.\n6. The toxicity of previous therapy has not recovered to Grade 1 or below.\n7. Known peripheral neuropathy (CTCAE ≥ Grade 2).\n8. Known deficiency of dihydropyrimidine dehydrogenase (DPD)\n9. Subjects with a confirmed diagnosis of Gilbert's syndrome","ALL","18 Years","75 Years",{"count":65,"type":66},408,"ESTIMATED","INTERVENTIONAL",[69],"PHASE3","This study will evaluate the efficacy and safety of adjuvant therapy with liposomal irinotecan in combination with oxaliplatin, and S-1 compared with capecitabine combined with capecitabine in participants with pancreatic ductal adenocarcinoma after radical surgery.",[72],"Pancreatic Cancer","NOT_YET_RECRUITING","2024-08-25",{"date":76,"type":77},"2024-08-27","ACTUAL",{"date":79,"type":66},"2024-09",{"date":81,"type":66},"2029-03",{"name":5,"class":6}]