[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554923":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":42,"responsibleParty":60,"collaborators":11,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":11,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":11,"enrollmentInfo":71,"targetDuration":11,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":11,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SYHX2008 injection","EXPERIMENTAL",null,[13],"Drug: SYHX2008 injection",{"label":15,"type":16,"description":11,"interventionNames":17},"Octreotide Microspheres cohort (Sandostatin LAR@)","ACTIVE_COMPARATOR",[18],"Drug: Sandostatin LAR@",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","The patients will accept SYHX2008 injection by subcutaneous administration every cycle.",[9],{"type":21,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Sandostatin LAR@","The patients will accept Sandostatin LAR@ by intra-muscular administration every cycle.",[15],[29],{"name":30,"affiliation":31,"role":32},"Jianming Xu, M.D","The First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China","STUDY_CHAIR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",{"name":30,"role":36,"phone":40,"phoneExt":11,"email":41},"010-66947176","Jianmingxu2014@163.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Chinese PLA General Hosptial","RECRUITING","Beijing","Beijing Municipality","100853","China","CN",{"type":52,"coordinates":53},"Point",[54,55],116.39723,39.9075,{"lat":55,"lon":54},[58,59],{"name":30,"role":36,"phone":40,"phoneExt":11,"email":41},{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},{"type":61,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100554923","phase-2-a-trial-to-assess-efficacy-safety-pharmacokinetics-of-octreotide-subcutaneous-injection-in-patients-with-gastroentero-pancreatic-neuroendocrine-tumor-gep-net-100554923",false,"NCT06505395","A Trial to Assess Efficacy, Safety, Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine Tumor (GEP-NET)","A Phase Ⅱ Randomized, Parallel-group, Open-label, Active-controlled Trial to Assess the Efficacy, Safety and Pharmacokinetics of the Long-acting Octreotide Subcutaneous Injection (SYHX2008) Versus Octreotide Microspheres (Sandostatin LAR@) in Patients With GEP-NET","Inclusion Criteria:\n\n1. Male or female patient ≥18 years old;\n2. Histologically confirmed, advanced GEP-NET;\n3. At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1;\n4. Previous treatment with ≤2 systemic antitumor drugs;\n5. Patients who do not have liver metastasis, with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and alkaline phosphatase (ALP) levels ≤ 2.5 times the upper limit of normal (ULN) ; and who do have liver metastasis, with ALT and AST ≤ 5 times ULN; Serum total bilirubin \\\u003C1.5 times the ULN; absolute neutrophil count (ANC) of ≥1.5×10\\^9\u002FL, platelet count of ≥90×10\\^9\u002FL, and hemoglobin ≥9 g\u002FdL; or International Normalized Ratio (INR) ≤1.5 ULN and activated partial thromboplastin time (APTT) ≤1.5 ULN;\n6. ECOG performance status of 0 to 1\n7. Have expected survival of more than 3 months;\n8. Adequately understand the study and voluntarily sign the Informed Consent Form;\n9. Females patients with reproductive potential must agree to use an effective contraceptive method, for example, intrauterine devices, birth control medicine or condoms, during the study and within 3 months after study treatment discontinuation; or serum pregnancy tests negative and must be non-lactating participants; or males should agree contraception during the study and for within 3 months after study treatment discontinuation.\n\nExclusion Criteria:\n\n1. Uncontrolled or severe diarrhea with significant dehydration;\n2. Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection;\n3. Anti-tumor therapy received within 4 weeks prior to the initiation of the investigational treatment, for example mammalian target of rapamycin (mTOR) inhibitors or multi-target tyrosine kinase inhibitors (TKI); or short-acting octreotide acetate was received subcutaneously or intravenously within 1 weeks prior to the initiation of the investigational treatment;\n4. Interferon was received within 4 weeks prior to the initiation of the investigational treatment; or chemotherapy was received within 4 weeks prior to the initiation of the investigational treatment; or transarterial chemoembolization was received within 12 months prior to screening; or previously received peptide receptor radionuclide therapy (PRRT) at any time; or received radiation therapy, anti-tumor traditional Chinese medicine treatment, hepatic artery intervention embolization, liver metastasis cryoablation or radiofrequency ablation, and other systemic anti-tumor drug treatments within 4 weeks prior to the initiation of the investigational treatment; or had participated in other clinical trials within 30 days prior to screening\n5. Surgery (except biopsy) within 28 days prior to the initiation of investigational treatment or unhealed surgical incision;\n6. Glycated hemoglobin (HbA1c) \\> 8.5%;\n7. Patients have symptomatic cholelithiasis or a history of symptomatic cholelithiasis at screening, but with no performed surgery treatment;\n8. Patients with active brain metastases or cancerous meningitis meet any of the following criteria: a) Patients with prior brain metastases, imaging within 4 weeks prior to the first use of investigational drug show progression of the original lesion, or new brain metastases; b) Clinical symptoms associated with central nervous system metastasis did not recovery to baseline; c) Use cortisols, radiotherapy and other drugs to control the symptoms of central nervous system metastasis within 4 weeks before the first use of the investigational drug;\n9. The adverse reactions of previous antitumor therapy have not returned to ≤ grade 1 according to CTCAE V5.0 (except that the investigators evaluate no safety risk, such as hair loss, grade 2 peripheral neuropathy or dysfunction);\n10. Any clinically significant uncontrolled neurological, gastrointestinal, renal (serum creatinine \\> 1.5 ULN), pulmonary, or other significant disease requiring exclusion assessed in the opinion of the Investigator;\n11. Patients had hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×10\\^4\u002Fml or ≥2000 IU\u002Fml); known Hepatitis C antibodies positive and HCV RNA higher than the lower detection limit ; or human immunodeficiency virus (HIV) positive, treponema pallidum antibody positive;.\n12. A history of allergy to any excipient of the investigational drug or any similar chemical structure to the investigational drug;\n13. Patients had any severe or uncontrolled disease, including: 1) poor blood pressure control (systolic ≥160 mmHg or diastolic ≥100 mmHg);2) grade I or higher myocardial ischemia or myocardial infarction, symptomatic or poorly controlled arrhythmia, or congenital long QT syndrome (including QTcF ≥450ms for males, QTcF ≥470ms for females), or ≥ Grade 2 congestive heart failure \\[NYHA classification\\]; 3) serious infections that are not under control (oral or intravenous systemic anti-infection therapy is required for 2 weeks before the first use of the investigational drug, except for uncomplicated urinary tract infections and upper respiratory tract infections);4) previous or current severe bleeding (\\>30ml of bleeding within 3 months), hemoptysis (\\>5ml of fresh blood within 4 weeks), or thromboembolic events (including transient ischemic attacks) within 12 months;\n14. Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions are inappropriate for the use of the investigational product or affect interpretation of study results.","ALL","18 Years",{"count":72,"type":73},90,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","The purpose of this study is to compare the effectiveness, safety, pharmacokinetics (PK) of SYHX2008 vs Octreotide Microspheres (Sandostatin LAR@) in patients with advanced, well-differentiated GEP-NET.",[79],"Gastrointestinal Neuroendocrine Pancreatic Tumor","2024-08-22",{"date":82,"type":83},"2024-08-26","ACTUAL",{"date":85,"type":83},"2024-07-30",{"date":87,"type":73},"2028-08-01",{"name":5,"class":6},1]