[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507197":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":73,"collaborators":11,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":11,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":11,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Jiangsu HengRui Medicine Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group A","EXPERIMENTAL",null,[13],"Drug: Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide",{"label":15,"type":16,"description":11,"interventionNames":17},"Treatment group B","ACTIVE_COMPARATOR",[18],"Drug: long-acting Octreotide",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide","Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"long-acting Octreotide","High-dose long-acting Octreotide.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Xueying Zheng","CONTACT","+86-0518-82342973","xueying.zheng.xz17@hengrui.com",[36,57],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","201321","China","CN",{"type":45,"coordinates":46},"Point",[47,48],121.45806,31.22222,{"lat":48,"lon":47},[51,55],{"name":52,"role":32,"phone":53,"phoneExt":11,"email":54},"Xianjun Yu","+86-021-64175590","yuxianjun@fudanpci.org",{"name":52,"role":56,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"facility":58,"status":38,"city":59,"state":60,"zip":61,"country":42,"countryCode":43,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Tianjin University Cancer Institute and Hospital","Tianjin","Tianjin Municipality","300060",{"type":45,"coordinates":63},[64,65],117.17667,39.14222,{"lat":65,"lon":64},[68,72],{"name":69,"role":32,"phone":70,"phoneExt":11,"email":71},"Jihui Hao","022-23353454","herenrh@163.com",{"name":69,"role":56,"phone":11,"phoneExt":11,"email":11},{"type":74,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100507197","phase-3-an-open-label-phase-3-study-of-lutetium-177lu-oxodotreotide-injection-in-subjects-with-advanced-gastrointestinal-pancreatic-neuroendocrine-tumors-100507197",false,"NCT05884255","An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.","Randomized, Open, Positive Control Phase III Clinical Trial of Lutetium (177Lu) Oxodotreotide Injection Combined With Standard-dose Long-acting Octreotide Versus High-dose Long-acting Octreotide in the Treatment of Somatostatin Receptor-positive Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.","Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent;\n2. 18\\~75 years old,male or female;\n3. ECOG performance status 0 or 1;\n4. Unresectable locally advanced or metastatic gastrointestinal neuroendocrine tumors (GEP-NETs) of low and medium grade (G1 or G2) confirmed by histopathology.\n\nExclusion Criteria:\n\n1. Central nervous system metastasis is known. Patients who have previously received treatment ( radiotherapy or surgery ) for brain metastases and have no clinical symptoms can be enrolled if the pre-randomized pre-imaging is confirmed to be stable for at least 24 weeks;\n2. There are clinical symptoms or diseases of the heart that are not well controlled;\n3. Diabetes (fasting blood glucose \\> 2 × ULN) that cannot be well controlled after optimal medical support treatment;\n4. Severe urinary incontinence, hydronephrosis, severe micturition dysfunction or indwelling catheter for any reason.","ALL","18 Years","75 Years",{"count":86,"type":87},220,"ESTIMATED","INTERVENTIONAL",[90],"PHASE3","The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.",[93],"Advanced Gastroenteropancreatic Neuroendocrine Tumor","2026-05-15",{"date":96,"type":97},"2026-05-19","ACTUAL",{"date":99,"type":97},"2023-07-06",{"date":101,"type":87},"2030-10",{"name":5,"class":6},2]