[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605697":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":60,"collaborators":31,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":31,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":31,"enrollmentInfo":71,"targetDuration":31,"studyType":74,"phases":75,"briefSummary":78,"conditions":79,"keywords":31,"overallStatus":49,"whyStopped":31,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Sirolimus combined with octreotide","EXPERIMENTAL","Sirolimus for injection (albumin bound) combined with octreotide long-acting injection will be administrated on a 28-day cycle",[13,14],"Drug: Sirolimus for injection (albumin bound)","Drug: Octreotide long-acting injection",{"label":16,"type":10,"description":17,"interventionNames":18},"Sirolimus monotherapy","Sirolimus for injection (albumin bound) will be administrated on a 28-day cycle.",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Everolimus monotherapy","ACTIVE_COMPARATOR","Everolimus (QD) will be orally administrated on a 28-day cycle. Only for Phase III",[24],"Drug: Everolimus",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Sirolimus for injection (albumin bound)","Sirolimus for injection (albumin bound), ivgtt.",[9,16],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Octreotide long-acting injection","SC",[9],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Everolimus","Oral, once a day",[20],[41],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":31,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":31},"Chinese PLA General Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":55,"coordinates":56},"Point",[57,58],116.39723,39.9075,{"lat":58,"lon":57},{"type":61,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100605697","phase-2-sirolimus-for-injection-albumin-bound-combined-with-octreotide-long-acting-injection-in-patients-with-metastatic-gastroenteropancreatic-neuroendocrine-tumors-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":72,"type":73},298,"ESTIMATED","INTERVENTIONAL",[76,77],"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.",[80],"Gastroenteropancreatic Neuroendocrine Tumors","2026-04-21",{"date":83,"type":84},"2026-04-24","ACTUAL",{"date":86,"type":84},"2025-08-29",{"date":88,"type":73},"2028-08-29",{"name":5,"class":6},1]