[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507197":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":11,"studyPopulation":11,"armGroups":32,"interventions":43,"overallOfficials":11,"centralContacts":53,"locations":59,"responsibleParty":97,"collaborators":11,"id":99,"slug":11,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":11,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":11,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":11,"overallStatus":62,"whyStopped":11,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Jiangsu HengRui Medicine Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-free survival (PFS) assessed by BICR",null,"Up to 1 year follow-up",[14,17,20,22,24],{"measure":15,"description":11,"timeFrame":16},"Overall Survival (OS)","Up to 5 years follow-up",{"measure":18,"description":11,"timeFrame":19},"Objective Response Rate (ORR)","up to 1 year follow-up",{"measure":21,"description":11,"timeFrame":12},"Duration of Overall Response (DoR)",{"measure":23,"description":11,"timeFrame":12},"Disease Control Rate (DCR)",{"measure":25,"description":11,"timeFrame":16},"Incidence and severity of adverse event (AE) and serious adverse event (SAE)",{"allocation":27,"interventionModel":28,"interventionModelDescription":11,"primaryPurpose":29,"observationalModel":11,"timePerspective":11,"maskingInfo":30},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":31,"maskingDescription":11,"whoMasked":11},"NONE",[33,38],{"label":34,"type":35,"description":11,"interventionNames":36},"Treatment group A","EXPERIMENTAL",[37],"Drug: Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide",{"label":39,"type":40,"description":11,"interventionNames":41},"Treatment group B","ACTIVE_COMPARATOR",[42],"Drug: long-acting Octreotide",[44,49],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":11},"DRUG","Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide","Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide.",[34],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":11},"long-acting Octreotide","High-dose long-acting Octreotide.",[39],[54],{"name":55,"role":56,"phone":57,"phoneExt":11,"email":58},"Xueying Zheng","CONTACT","+86-0518-82342973","xueying.zheng.xz17@hengrui.com",[60,81],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","201321","China","CN",{"type":69,"coordinates":70},"Point",[71,72],121.45806,31.22222,{"lat":72,"lon":71},[75,79],{"name":76,"role":56,"phone":77,"phoneExt":11,"email":78},"Xianjun Yu","+86-021-64175590","yuxianjun@fudanpci.org",{"name":76,"role":80,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"facility":82,"status":62,"city":83,"state":84,"zip":85,"country":66,"countryCode":67,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Tianjin University Cancer Institute and Hospital","Tianjin","Tianjin Municipality","300060",{"type":69,"coordinates":87},[88,89],117.17667,39.14222,{"lat":89,"lon":88},[92,96],{"name":93,"role":56,"phone":94,"phoneExt":11,"email":95},"Jihui Hao","022-23353454","herenrh@163.com",{"name":93,"role":80,"phone":11,"phoneExt":11,"email":11},{"type":98,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":109,"type":110},220,"ESTIMATED","INTERVENTIONAL",[113],"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.",[116],"Advanced Gastroenteropancreatic Neuroendocrine Tumor","2026-05-15",{"date":119,"type":120},"2026-05-19","ACTUAL",{"date":122,"type":120},"2023-07-06",{"date":124,"type":110},"2030-10",{"name":5,"class":6},2]