[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastroenteropancreatic-neuroendocrine-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastroenteropancreatic-neuroendocrine-tumors":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"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":19,"type":20},298,"ESTIMATED","INTERVENTIONAL",[23,24],"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.",[27],"Gastroenteropancreatic Neuroendocrine Tumors","RECRUITING","2026-04-21",{"date":31,"type":32},"2026-04-24","ACTUAL",{"date":34,"type":32},"2025-08-29",{"date":36,"type":20},"2028-08-29",{"name":38,"class":39},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","INDUSTRY"]