[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594951":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":42,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":10,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":70,"maxAge":10,"enrollmentInfo":71,"targetDuration":74,"studyType":75,"phases":10,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":84,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group",null,"Liposomal irinotecan (Onivyde®)-based treatment.",[13],"Drug: Nal-IRI (Onivyde®)-based treatment",{"label":15,"type":10,"description":16,"interventionNames":17},"Control group","Real medication data from accepting other second-line treatment options in the China Pancreas Data Center (CPDC) project.",[18],"Drug: Other second-line treatment",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DRUG","Nal-IRI (Onivyde®)-based treatment","Nal-IRI (Onivyde®) combined with 5-FU\u002FLV is used for metastatic pancreatic ductal adenocarcinoma patients who have progressed after treatment with gemcitabine. The recommended dose of Nal-IRI (Onivyde®) is 70 mg\u002Fm\\^2, administered intravenously for 90 minutes, once every 2 weeks. In patients known to be homozygous for the UGT1A1 \\* 28 allele, the recommended starting dose of Nal-IRI (Onivyde®) is 50 mg\u002Fm\\^2, administered intravenously within 90 minutes. Based on tolerance, increase the dose of Nal-IRI (Onivyde®) to 70 mg\u002Fm\\^2 in subsequent cycles.",[9],{"type":21,"name":26,"description":26,"armGroupLabels":27,"otherNames":10},"Other second-line treatment",[15],[29],{"name":30,"affiliation":31,"role":32},"Liwei Wang, M.D.","Renji Hospital, School of Medicine, Shanghai Jiao Tong University","PRINCIPAL_INVESTIGATOR",[34,38],{"name":30,"role":35,"phone":36,"phoneExt":10,"email":37},"CONTACT","021-58752345","lwwang2013@163.com",{"name":39,"role":35,"phone":40,"phoneExt":10,"email":41},"Jiujie Cui, M.D.","13621958524","cuijiujie@126.com",[43],{"facility":31,"status":10,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Shanghai","Shanghai Municipality","200127","China","CN",{"type":50,"coordinates":51},"Point",[52,53],121.45806,31.22222,{"lat":53,"lon":52},[56],{"name":30,"role":35,"phone":36,"phoneExt":10,"email":37},{"type":58,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[60],{"name":61,"class":62},"Servier (Tianjin) Pharmaceutical Co. LTD.","INDUSTRY","100594951","a-real-world-study-of-liposomal-irinotecan-onivyde-based-therapy-in-patients-with-locally-advancedmetastatic-pancreatic-cancer-in-china-100594951",false,"NCT07026123","A Real-world Study of Liposomal Irinotecan (Onivyde)-Based Therapy in Patients With Locally Advanced\u002FMetastatic Pancreatic Cancer in China","Inclusion Criteria of the experimental group:\n\n* Age ≥ 18 years old.\n* Patients with locally advanced or metastatic PDAC diagnosed by pathology.\n* Patients who received at least one cycle of Nal-IRI (Onivyde®）+ 5-FU\u002FLV treatment.\n* Patients who have progressed in treatment with gemcitabine or gemcitabine containing regimens in the past.\n* The patient voluntarily participates in the study and signs an informed consent form.\n\nInclusion Criteria of the control group:\n\n* Age ≥ 18 years old.\n* Patients with locally advanced or metastatic PDAC diagnosed by pathology.\n* Not received Nal IRI (Onivyde®)+ 5-FU\u002FLV treatment in the past.\n\nExclusion Criteria:\n\n* Confirm pregnant or lactating women.\n* The patient's clinical data is not available.\n* The researchers determined that they were not suitable for inclusion in the study due to other circumstances.","ALL","18 Years",{"count":72,"type":73},40,"ESTIMATED","2 Years","OBSERVATIONAL","This study is designed to evaluate the real world efficacy and safety of the liposomal irinotecan (Onivyde®)-based treatment scheme in Chinese patients with locally advanced or metastatic pancreatic cancer, and to compare the efficacy with that of the whole pancreatic cancer population who did not receive relevant treatment.",[78],"Advanced Pancreatic Cancer",[80,81,82,83],"Pancreatic Cancer","chemotherapy","liposomal irinotecan","real world research","NOT_YET_RECRUITING","2025-06-10",{"date":87,"type":88},"2025-06-18","ACTUAL",{"date":90,"type":73},"2025-07-01",{"date":92,"type":73},"2027-07-31",{"name":5,"class":6},1]