[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605697":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":11,"studyPopulation":11,"armGroups":63,"interventions":81,"overallOfficials":11,"centralContacts":95,"locations":101,"responsibleParty":115,"collaborators":11,"id":117,"slug":11,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":11,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":124,"maxAge":11,"enrollmentInfo":125,"targetDuration":11,"studyType":128,"phases":129,"briefSummary":132,"conditions":133,"keywords":11,"overallStatus":104,"whyStopped":11,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":11},[9,13,16,18,20],{"measure":10,"description":11,"timeFrame":12},"Phase II: Incidences of Adeverse Events (AEs)",null,"Up to 3 years",{"measure":14,"description":11,"timeFrame":15},"Phase II: Dose Limiting Toxicity (DLT)","Up to 1 year",{"measure":17,"description":11,"timeFrame":15},"Phase II: Recommended Phase 3 Dose (RP3D)",{"measure":19,"description":11,"timeFrame":15},"Phase II: Objective Response Rate (ORR） per investigator",{"measure":21,"description":11,"timeFrame":12},"Phase III: Progression Free Survival (PFS) per Blinded Independent Review Committee (BIRC)",[23,25,27,29,31,33,35,37,40,43,45,47,49,51,53,55],{"measure":24,"description":11,"timeFrame":12},"Phase II: Duration of Response (DOR) per investigator",{"measure":26,"description":11,"timeFrame":12},"Phase II: Disease Control Rate (DCR) per investigator",{"measure":28,"description":11,"timeFrame":12},"Phase II: Progression Free Survival (PFS) per investigator",{"measure":30,"description":11,"timeFrame":12},"Phase II: Overall Survival (OS)",{"measure":32,"description":11,"timeFrame":12},"Peak Concentration：Cmax",{"measure":34,"description":11,"timeFrame":12},"Area under the plasma concentration-time curve: AUC",{"measure":36,"description":11,"timeFrame":12},"Half-Life: t1\u002F2",{"measure":38,"description":11,"timeFrame":39},"Phase II: Blood concentrations and PK parameters of sirolimus for injection(albumin bound) and Octreotide long-acting injection.","From first dose of treatment to C3D15",{"measure":41,"description":11,"timeFrame":42},"Phase II: Changes in serum chromogranin A, 24-hour urinary 5-hydroxyindoleacetic acid, and serum IGF-1 levels from baseline.","From first dose of treatment to end of treatment",{"measure":44,"description":11,"timeFrame":12},"Phase III: Progression Free Survival (PFS) per investigator",{"measure":46,"description":11,"timeFrame":12},"Phase III: Objective Response Rate (ORR）",{"measure":48,"description":11,"timeFrame":12},"Phase III: Duration of Response (DOR)",{"measure":50,"description":11,"timeFrame":12},"Phase III: Disease Control Rate (DCR)",{"measure":52,"description":11,"timeFrame":12},"Phase III: Incidences of Adeverse Events (AEs)",{"measure":54,"description":11,"timeFrame":12},"Phase III: Overall Survival (OS)",{"measure":56,"description":11,"timeFrame":42},"Phase III: Changes in serum chromogranin A, 24-hour urinary 5-hydroxyindoleacetic acid, and serum IGF-1 levels from baseline.",{"allocation":58,"interventionModel":59,"interventionModelDescription":11,"primaryPurpose":60,"observationalModel":11,"timePerspective":11,"maskingInfo":61},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":62,"maskingDescription":11,"whoMasked":11},"NONE",[64,71,75],{"label":65,"type":66,"description":67,"interventionNames":68},"Sirolimus combined with octreotide","EXPERIMENTAL","Sirolimus for injection (albumin bound) combined with octreotide long-acting injection will be administrated on a 28-day cycle",[69,70],"Drug: Sirolimus for injection (albumin bound)","Drug: Octreotide long-acting injection",{"label":72,"type":66,"description":73,"interventionNames":74},"Sirolimus monotherapy","Sirolimus for injection (albumin bound) will be administrated on a 28-day cycle.",[69],{"label":76,"type":77,"description":78,"interventionNames":79},"Everolimus monotherapy","ACTIVE_COMPARATOR","Everolimus (QD) will be orally administrated on a 28-day cycle. Only for Phase III",[80],"Drug: Everolimus",[82,87,91],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":11},"DRUG","Sirolimus for injection (albumin bound)","Sirolimus for injection (albumin bound), ivgtt.",[65,72],{"type":83,"name":88,"description":89,"armGroupLabels":90,"otherNames":11},"Octreotide long-acting injection","SC",[65],{"type":83,"name":92,"description":93,"armGroupLabels":94,"otherNames":11},"Everolimus","Oral, once a day",[76],[96],{"name":97,"role":98,"phone":99,"phoneExt":11,"email":100},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",[102],{"facility":103,"status":104,"city":105,"state":106,"zip":11,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":11},"Chinese PLA General Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":110,"coordinates":111},"Point",[112,113],116.39723,39.9075,{"lat":113,"lon":112},{"type":116,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100605697",false,"NCT07165886","Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors","Phase II\u002FIII Study to Evaluate the Safety and Efficacy of Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)","Inclusion Criteria:\n\n* 1\\. Unresectable locally advanced or metastatic G1\u002FG2 GEP-NETs diagnosed by histology, according to the 2019 WHO histological grading criteria.\n* 2\\. Having poor prognostic factors.\n* 3\\. Non-functional GEP-NETs are required.\n* 4\\. At least one evaluable lesion meets the RECIST V1.1 standard (Applicable only to the phase II safety run-in stage)\n* 6\\. ECOG 0\\~2.\n* 7\\. Organ function reserve is good.\n* 8\\. Be able to sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Patients who have previously received SSTR-targeted therapies (including somatostatin analogs \\[SSAs\\] and peptide receptor radionuclide therapy) and\u002For mTOR inhibitors (Patients who received SSAs in the adjuvant setting and experienced recurrence ≥6 months after treatment completion may be enrolled)\\[ Applicable to Phase II dose expansion and Phase III stages\\].\n* 2\\. Has uncontrolled\u002Fsevere diarrhea or an axillary temperature \\> 38.0°C at enrollment.\n* 3\\. Received treatment with other unlisted clinical investigational drugs within 4 weeks prior to the first use of the investigational drug.\n* 4\\. Undergone major surgical procedures within 4 weeks prior to the first use of the investigational drug and have not fully recovered.\n* 5\\. Received systemic use of corticosteroids or other immunosuppressive therapy within 2 weeks prior to the first use of the study drug.\n* 6\\. With an infection that requires systemic anti-infective treatment within 2 weeks prior to the first use of the study drug.\n* 7\\. Those who have used strong inhibitors or inducers of CYP3A4 liver metabolic enzymes within 2 weeks prior to the first use of the investigational drug or still need to continue using such drugs.\n* 8\\. Has a serious history of cardiovascular and cerebrovascular diseases.\n* 9\\. Having active brain metastasis and\u002For malignant meningitis.\n* 10\\. With a history of severe lung diseases.\n* 11\\. During screening, there may be symptomatic gallstones or a history of symptomatic gallstones but no surgical treatment has been performed.\n* 12\\. Abnormal thyroid function during screening.\n* 13\\. Known to have hypersensitivity reactions or intolerance to any component of all investigational drugs or their excipients.\n* 14\\. Active hepatitis B, active hepatitis C virus infection, or active syphilis infection.\n* 15\\. History of autoimmune diseases (excluding tuberous sclerosis), history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.","ALL","18 Years",{"count":126,"type":127},298,"ESTIMATED","INTERVENTIONAL",[130,131],"PHASE2","PHASE3","There is limited evidence regarding the benefit of adding somatostatin analogs to molecular targeted agents for well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with poor prognostic factors. This trial is conducted to evaluate sirolimus for injection (albumin bound) combined with octreotide long-acting injection in patients with unresectable or recurrent GEP-NETs.",[134],"Gastroenteropancreatic Neuroendocrine Tumors","2026-04-21",{"date":137,"type":138},"2026-04-24","ACTUAL",{"date":140,"type":138},"2025-08-29",{"date":142,"type":127},"2028-08-29",{"name":5,"class":6},1]