[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545528":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":55,"centralContacts":55,"locations":55,"responsibleParty":56,"collaborators":55,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":55,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":55,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":55,"overallStatus":77,"whyStopped":55,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":55},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"HR070803+Oxaliplatin+S-1","EXPERIMENTAL","Drug: HR070803（Irinotecan Liposome）; Oxaliplatin; Tegafur HR070803 60 mg\u002F\\^2 D1 over 90 minutes. Oxaliplatin 85 mg\u002F\\^2 D1 over 2 hours. Tegafur The initial dose of S-1 is determined according to the body surface area，orally, D1-7.\n\nThese drugs are given once every 2 weeks, 4 weeks as one cycle, 6 treatment cycles.",[13,14,15],"Drug: HR070803","Drug: Oxaliplatin","Drug: Tegafur",{"label":17,"type":18,"description":19,"interventionNames":20},"HR070803+Oxaliplatin+5-FU\u002FLV","ACTIVE_COMPARATOR","Drug: HR070803; Oxaliplatin; 5-Fluorouracil; Calcium folinate HR070803 60 mg\u002F\\^2 D1 over 90 minutes. Oxaliplatin 85 mg\u002F\\^2 D1 over 2 hours. Folinic acid 400 mg\u002F\\^2 D1, IV infusion over 1 hours. 5-FU 2400 mg\u002F\\^2 D1 IV continuous infusion over 46 hours.\n\nThese drugs are given once every 2 weeks, 4 weeks as one cycle, 6 treatment cycles.",[13,14,21,22],"Drug: Folinic acid","Drug: 5-Fluorouracil",[24,31,37,43,49],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","HR070803","HR070803 60 mg\u002F\\^2 D1 over 90 minutes.",[17,9],[30],"Irinotecan Liposome",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Oxaliplatin","Oxaliplatin 85 mg\u002F\\^2 D1 over 2 hours.",[17,9],[36],"L-OHP",{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Tegafur","initial dose of S-1 is determined according to the body surface area，orally, D1-7.",[9],[42],"S-1",{"type":25,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Folinic acid","Folinic acid 400 mg\u002F\\^2 D1",[17],[48],"LV",{"type":25,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"5-Fluorouracil","5-FU 2400 mg\u002F\\^2 D1 IV continuous infusion over 46 hours",[17],[54],"5-FU",null,{"type":57,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR","100545528","phase-2-hr070803-in-combination-with-oxaliplatin-s-1-versus-nalirifox-as-adjuvant-therapy-for-pancreatic-cancer-100545528",false,"NCT06383078","HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer","HR070803 in Combination With Oxaliplatin Plus Tegafur Versus HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate as Adjuvant Therapy for Pancreatic Cancer: A Multicenter, Multi-cohort, Randomized, Phase II Study","Inclusion Criteria:\n\n1. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).\n2. ECOG performance status 0 or 1.\n3. Life expectancy of greater than or equal to 6 months.\n4. Full recovery from surgery and patient is scheduled to start treatment within 3 weeks to 12 weeks after surgery.\n5. The number of lymph nodes dissected during resection ≥ 15.\n6. Able and willing to provide a written informed consent.\n\nExclusion Criteria:\n\n1. Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;\n2. Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma.\n3. CA19-9 exceeding normal value within 14 days prior to enrollment.\n4. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.\n5. Severe infection (\\> CTCAE grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment;\n6. Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.","ALL","20 Years","75 Years",{"count":69,"type":70},120,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil\u002Fleucovorin (5FU\u002FLV) treatment as adjuvant therapy in patients with resected pancreatic cancer.",[76],"Efficacy and Safety","NOT_YET_RECRUITING","2024-04-22",{"date":80,"type":81},"2024-04-25","ACTUAL",{"date":83,"type":70},"2024-04-20",{"date":85,"type":70},"2027-12-30",{"name":5,"class":6}]