[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604938":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":20,"responsibleParty":31,"collaborators":20,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":20,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":20,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":58,"whyStopped":20,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":20},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Surufatinib + Surufatinib + Sintilimab","EXPERIMENTAL","After fully informed and signed informed consent, subjects will receive Sintilimab (200mg each fixed dose, once every 21 days) combined with Temozolomide (body surface area（BSA）≤1.7m2; BSA \\>1.7m2 was administered with 300mg, once daily, d1-d5, and with Surufatinib (250mg, once daily, continuous administration). A treatment cycle of 21 days until disease progression, death, toxicity intolerance or withdrawal of informed consent, with a maximum treatment period of 24 months.",[13],"Drug: Sintilimab+Temozolomide+Surufatinib",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Sintilimab+Temozolomide+Surufatinib","After fully informed and signed informed consent, subjects will receive Sintilimab (200mg each fixed dose, once every 21 days) combined with Temozolomide (BSA≤1.7m2; BSA \\> 1.7m2 was administered with 300mg, QD, d1-d5, and with Surufatinib (250mg, QD, continuous administration). A treatment cycle of 21 days until disease progression, death, toxicity intolerance or withdrawal of informed consent, with a maximum treatment period of 24 months.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Yihebali Chi","National Cancer Center\u002FNational Clinical Research Center for Cancer\u002FCancer Hospital","STUDY_CHAIR",[27],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","010-67781331","yihebalichi@hotmail.com",{"type":32,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100604938","phase-2-sintilimab-in-combination-with-surufatinib-and-temozolomide-in-the-advanced-neuroendocrine-carcinoma-100604938",false,"NCT07156019","Sintilimab in Combination With Surufatinib and Temozolomide in the Advanced Neuroendocrine Carcinoma","A Prospective, Single-center, Single-arm Phase II Study of Sintilimab in Combination With Surufatinib and Temozolomide in the Treatment of Advanced Neuroendocrine Carcinoma","Inclusion Criteria:\n\n1. The subjects voluntarily joined the study, signed the informed consent, and the compliance was good;\n2. Locally advanced unresectable or metastatic neuroendocrine carcinoma confirmed by histopathology or cytology (excluding small cell lung cancer);\n3. Disease progression or toxicity intolerance after previous first-line and above treatment;\n4. At least one measurable lesion according to RECIST v1.1;\n5. Eastern Cooperative Oncology Group Performance Status（ECOG PS） score is 0-1;\n6. Age ≥18 and ≤75 years old;\n7. Can provide tumor specimens for biomarker detection；\n8. Major organ and bone marrow function levels meet the following requirements within 7 days prior to treatment:\n\n   ① Blood routine: Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; Platelet count (PLT) ≥90×10\\^9\u002FL; Hemoglobin (Hb) ≥9.0 g\u002FdL; Have not received transfusions of blood products (including erythrocyte and platelet products, etc.) and have not used supportive therapy of growth factors (including colony-stimulating factor, interleukin and erythropoietin, etc.) within 2 weeks before the examination;\n\n   ② Liver function: serum total bilirubin (TBIL) ≤1.5× upper limit of normal value (ULN); alanine Aminotransferase（ALT） and aspartate aminotransferase (AST) in subjects without liver metastasis ≤3.0×ULN, and ALT and AST in subjects with liver metastasis ≤5.0×ULN;\n\n   ③ Renal function: serum creatinine (Cr) ≤1.5×ULN;\n\n   ④ Coagulation function: International standardized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;\n\n   ⑤ Urine routine results showed that urine protein \\\u003C2+; For patients with urine protein ≥2+ in routine urine testing at baseline, a 24-hour urine protein quantity of \\\u003C1g is required;\n9. Expected survival time ≥3 months;\n10. Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period.\n\nExclusion Criteria:\n\n1. Previous exposure to any anti-PD-1 \u002FPD-L1\u002FPD-L2\u002FCTLA-4 antibody, VEGF\u002FVEGFR targeting drugs;\n2. Previous treatment with temozolomide;\n3. Received chemotherapy, targeted therapy, Chinese herbal medicine with anti-tumor indications, or immunomodulatory drugs within 4 weeks prior to enrollment, or remained within 5 half-lives of such drugs;\n4. Known to be allergic to any monoclonal antibody, temozolomide preparations, and solfantinib preparations;\n5. Use of immunosuppressive drugs within 4 weeks prior to initial administration, excluding nasal, inhalation, or other routes of local corticosteroids or physiological doses of systemic corticosteroids;\n6. There was toxicity caused by previous anti-tumor therapy that did not recover to NCI CTCAE5.0 version ≤ Grade 1 before the first administration;\n7. History of other primary malignancies, except the following: non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence, carcinoma in situ with adequate treatment and no evidence of disease recurrence;\n8. Patients with metastatic central nervous system or cancerous meningitis with clinical symptoms;\n9. Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe cirrhosis;\n10. Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of the drug;\n11. Have serious heart disease or discomfort;\n12. The patient has any active autoimmune disease or a history of autoimmune disease within 2 years;\n13. Pregnant or nursing female patients;\n14. A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;\n15. Had undergone major surgery within 4 weeks prior to enrollment or expected to require major surgery during the study treatment;\n16. Concurrent participation in another interventional clinical study, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study;\n17. Has a serious concomitant disease or other comorbidities that interfere with planned treatment;\n18. Any other circumstances deemed inappropriate for participation in this study by the investigator.","ALL","18 Years","75 Years",{"count":44,"type":45},32,"ESTIMATED","INTERVENTIONAL",[48],"PHASE2","This study will evaluate the efficacy, safety and tolerability of Surufatinib + Temozolomide + Sintilimab in subjects. A treatment cycle of 21 days until disease progression, death, toxicity intolerance or withdrawal of informed consent, with a maximum treatment period of 24 months. Efficacy evaluation was performed at the end of every 2 treatment cycles. After termination of study treatment, participants will be followed up for safety and survival (survival follow-up every 90 days).",[51],"Neuroendocrine Carcinomas (NEC)",[53,54,55,56,57],"Surufatinib","Temozolomide","Sintilimab","Neuroendocrine carcinomas","Prospective observational study","NOT_YET_RECRUITING","2025-09-03",{"date":61,"type":62},"2025-09-04","ACTUAL",{"date":64,"type":45},"2025-10",{"date":66,"type":45},"2027-12",{"name":5,"class":6}]