[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519047":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":19,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":19,"eligibilityCriteria":52,"healthyVolunteers":49,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":19,"studyType":59,"phases":60,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":28,"whyStopped":19,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Surufatinib Combined With Temozolomide and S-1","EXPERIMENTAL","Patients will receive surufatinib combined with temozolomide and S-1 once every three weeks as the second-line treatment until disease progression or intolerable toxicity or patients withdrawal of consent.\n\nPhase I: DLTs of surufatinib combined with temozolomide and S-1 will be evaluated based on NCI CTCAE v 5.0 in the first cycle.",[13],"Drug: Surufatinib Combined With Temozolomide and S-1",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Phase I:\n\nSurufatinib: 250mg, QD, PO, Q3W; Temozolomide: 200-300mg, d10-d14, QD, PO, Q3W; S-1: 40-60mg, d1-d14, BID, PO, Q3W.\n\nPhase II:\n\nSurufatinib, Temozolomide and S-1：RP2D",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Yihebali Chi, PhD","CONTACT","010-67781331","yihebalichi@hotmail.com",[27],{"facility":5,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":35,"coordinates":36},"Point",[37,38],116.39723,39.9075,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":19,"phoneExt":19,"email":19},"Yihebali Chi, doctor",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Yihebali Chi, MD","Professor, Department of Medical Oncology","100519047","phase-1-an-open-single-center-clinical-study-of-surufatinib-combined-with-temozolomide-and-s-1-in-the-first-line-treatment-of-advanced-neuroendocrine-tumors-100519047",false,"NCT06038461","An Open, Single-center Clinical Study of Surufatinib Combined With Temozolomide and S-1 in the First-line Treatment of Advanced Neuroendocrine Tumors","Inclusion Criteria:\n\n* Aged 18-75years (inclusive);\n* Histopathologically confirmed diagnosis of advanced MGMT0\u002F1+ (G1, G2 or G3) neuroendocrine tumor (locally advanced, unresectable or distant metastasis);\n* Previously untreated with systemic therapy;\n* Have at least one measurable lesion according to RECIST v1.1;\n* ECOG performance status: 0-2(determined by investigator);\n* Expected survival time \\> 3 months;\n* Adequate hepatic, renal, heart, and hematologic functions;\n* Urine protein \\\u003C ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;\n* Before the first dose, serum HCG examination of potential childbearing-women must be negative; Men\u002FWomen of childbearing potential must agree to use a highly effective contraceptive method (such as double barrier contraceptive method, condom, oral or injectable contraceptives and intrauterine device) throughout treatment and for at least 90 days after study completion.\n\nExclusion Criteria:\n\n* Neuroendocrine cancer, adenocarcinoid, goblet cell carcinoid,\n* Functional NETs which need to control symptoms by long-acting somatostatin analogues;\n* Received a major surgery which requires at least 3 weeks after recovery time, to undergo surgery on treatment of this research within 4 weeks prior to treatment;\n* Have uncontrolled hypertension, defined as systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mm Hg, while under anti-hypertension treatment;\n* Patients with active ulcer, intestinal perforation and intestinal obstruction;\n* With active bleeding or bleeding tendency;\n* Severe history of cardiovascular and cerebrovascular diseases;\n* Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.","ALL","18 Years","75 Years",{"count":57,"type":58},40,"ESTIMATED","INTERVENTIONAL",[61,62],"PHASE1","PHASE2","This is a prospective, open, single-center study evaluating the efficacy and safety of surufatinib Combined With Temozolomide and S-1 as the first-line treatment of advanced neuroendocrine tumors",[65],"Neuroendocrine Tumors",[67,68,69],"Surufatinib","Temozolomide and S-1","First-line treatment","2026-07-23",{"date":72,"type":73},"2026-07-24","ACTUAL",{"date":75,"type":73},"2023-09-15",{"date":77,"type":58},"2028-09-15",{"name":5,"class":6},1]