[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroendocrine-carcinomas-nec\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroendocrine-carcinomas-nec":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,92,121],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100584778","phase-2-efficacy-and-safety-evaluation-of-tarlatamab-in-advanced-extrapulmonary-neuroendocrine-carcinoma-patients-100584778",false,"NCT06893783","Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients","A Phase II Trial of Tarlatamab, a DLL3-targeted Bispecific T-cell Engager, in Patients With Advanced Extrapulmonary Neuroendocrine Carcinoma (DeLLight)","DeLLight","Inclusion Criteria:\n\n\\- Subject has provided informed consent prior to initiation of any study specific activities\u002Fprocedures.\n\n* Age ≥19 years at the time of signing the informed consent.\n* Histologically confirmed relapsed\u002Frefractory extra-pulmonary neuroendocrine carcinoma. Neuroendocrine carcinoma includes small cell carcinoma, large cell carcinoma, and mixed histology of neuroendocrine and other histology (e.g., adenoneuroendocrine carcinoma, urothelial carcinoma with neuroendocrine component). In patients with prostate cancer, treatment-emergent neuroendocrine carcinoma (initially adenocarcinoma, but transdifferentiate into neuroendocrine carcinoma after androgen deprivation therapy) will be permitted.\n* Cohort 1 (gastrointestinal and pancreaticobiliary cohort): cancers originated from stomach, esophagus, small intestine, colorectal, pancreas, or bile ducts.\n* Cohort 2 (genitourinary cohort): cancers originated from prostate, bladder, ureter, urethra, or kidney.\n* Subject has progressed or recurred following 1 platinum-based regimen:\n* documented first disease progression must be during or following first-line platinum-based systemic chemotherapy. For patients with prostate cancer, especially in cases with treatment-emergent neuroendocrine carcinoma, platinum-based chemotherapy will not need to be the first line therapy.\n\n  * patients who received treatment for localized disease who recur are eligible\n  * patients who received adjuvant Platinum-Etoposide (EP) after resection of their primary tumor who recur are eligible\n* Measurable disease as defined per RECIST 1.1 within the 21-day screening period.\n\n  • Screening scans performed as SOC(Standard of Care) and prior to informed consent, may be used to confirm subject eligibility if completed within the 21-day screening period, provided that informed consent for the use of these scans is obtained prior to any transfer of data.\n  * In patients with prostate cancer, patients without RECIST-defined measurable lesion can be included, if disease can be evaluated with Prostate Cancer Working Group(PCWG)-3 criteria.\n* Eastern Cooperative Oncology Group (ECOG) PS(Performance Status) of 0 - 2.\n* Minimum life expectancy of 12 weeks.\n* Adequate organ function, defined as follows:\n\n  • Hematological function: Absolute neutrophil count ≥ 1.5 x 10\\^9 \u002FL Platelet count ≥ 100 x 10\\^9\u002FL Hemoglobin \\> 9 g\u002FdL (90 g\u002FL)\n\n  • Coagulation function: Prothrombin Time (PT)\u002FInternational Normalized Ratio (INR) and Partial Thromboplastin Time (PTT) or activated Partial Thromboplastin Time (APTT) ≤ 1.5 x institutional upper limit of normal (ULN) except for subjects undergoing new class anticoagulant therapy (eg, Edoxaban), stable dose for 2 weeks required prior to enrollment.\n\n  • Renal function: estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 or creatinine clearance ≥ 30 mL\u002Fmin as determined by Cockcroft-Gault equation (Cockcroft and Gault 1976)\n\n  • Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN (or \\\u003C5 x ULN for subjects with liver involvement) total bilirubin (TBL) \\\u003C1.5 x ULN (\\\u003C2 x ULN for subjects with liver involvement) (except participants with Gilbert syndrome who must have total bilirubin \\\u003C3.0 mg\u002FdL)\n\n  • Pulmonary function: no clinically significant pleural effusion. Pleural effusion managed with indwelling pleural catheter (eg, PleurX) are allowed baseline oxygen saturation \\>90% on room air\n\n  • Cardiac function: cardiac ejection fraction ≥50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) findings Provision of evaluable tumor samples for central testing (archival or in-study biopsy)\n\nExclusion Criteria:\n\n* Symptomatic central nervous system (CNS) metastases:\n\n  • Subjects with treated brain metastases are eligible provided the following criteria are met:\n* Subject is asymptomatic from brain metastases\n* Whole brain radiation or surgery was completed at least 2 weeks prior to first dose of study treatment (stereotactic radiosurgery completed at least 7 days prior to first dose of study treatment)\n* Any CNS disease is clinically stable, subject is off steroids for CNS disease for at least 5 days (unless steroids are indicated for a reason unrelated to CNS disease), and subject is off or on stable doses of anti-epileptic drugs at least 14 days prior to first dose of study treatment • Subjects with untreated brain metastases that are asymptomatic and do not require corticosteroids, nor local therapy per investigators standard of practice are allowed Diagnosis or evidence of leptomeningeal disease.\n\nPrior history of immune checkpoint inhibitors resulting in:\n\n* Any severe or life-threatening immune-mediated adverse event, History of immune-mediated encephalitis or other immune-mediated CNS event (any grade)\n* Grade ≥ 2 immune-mediated recurrent pneumonitis, Infusion-related reactions leading to permanent discontinuation of immunotherapy agent Exception: Subjects with a history of immune checkpoint inhibitor-induced endocrinopathy which is clinically stable on replacement therapy.\n\n  * Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.\n  * History of solid organ transplantation.\n  * History of other malignancy within the past 2 years, with the following exceptions:\n* low-risk malignancy treated with curative intent and with no known active disease present for ≥ 1 year before enrollment and believed to be at low risk for recurrence per investigator discretion.\n* adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, cervical carcinoma in situ without evidence of disease, breast ductal carcinoma in situ without evidence of disease.\n* prostatic intraepithelial neoplasia without evidence of prostate cancer. (For non-prostate cancer patient)\n* adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.\n\n  * Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II) within 12 months prior to first dose of study treatment (Section 11.9).\n  * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months prior to first dose of study treatment.\n  * Presence\u002Fhistory of viral infection: Human immunodeficiency virus (HIV) infection\n* Subjects with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study per local or institutional guidelines, Active hepatitis C infection (subjects with detectable hepatitis C antibody \\[HCV Ab\\] and HCV RNA viral load above the limit of quantification),\n* Subjects with presence of HCV Ab and HCV RNA viral load below the limit of quantification (HCV RNA negative) with or without prior treatment are allowed Active hepatitis B infection (presence of hepatitis B surface antigen \\[HBsAg\\] and hepatitis B virus \\[HBV\\] DNA viral load above the limit of quantification \\[HBV DNA positive\\])\n* Subjects with resolved HBV infection defined as absence of HBsAg and presence of HBV core antibody (anti-HBc) followed by an HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed, with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.\n* Subjects with chronic HBV infection inactive carrier state defined as presence of HBsAg and HBV DNA viral load below the limit of quantification \\[HBV DNA negative\\] are allowed, with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.\n\nReceiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment:\n\n* Prophylactic dexamethasone required by the protocol and any anti-emetic therapies are allowed\n* Low-dose corticosteroids (prednisone ≤10 mg per day or equivalent is permitted during the trial)\n\n  * Subject with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.\n  * Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n  * Prior therapy with tarlatamab\n  * Prior therapy with any selective inhibitor of the DLL3 pathway.\n  * Subject received more than 2 prior systemic therapy regimens for EPNECs. In patients with treatment-emergent prostate neuroendocrine carcinoma, treatments given before histological confirmation of neuroendocrine cancer (e.g., androgen deprivation therapy, androgen receptor targeted agents such as enzalutamide and abiraterone, and docetaxel) are not considered as previous treatment for metastatic\u002Frecurrent EPNEC.\n  * Prior anti-cancer therapy within 21 days prior to first dose of study treatment. Exceptions:\n* Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to grade ≤ 1, or to levels dictated in the eligibility criteria, before first dose of study treatment, with the exception of alopecia or toxicities considered irreversible (defined as having been present and stable for \\>30 days) which are not otherwise described in the exclusion criteria.\n* Prior palliative radiotherapy must have been completed at least 7 days before the first dose of study treatment.\n\n  * Receiving anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy. Patients who are receiving adjuvant hormonal therapy for resected breast cancer may be eligible (refer also to exclusion related to history of other malignancies). Additionally, in patients with treatment-emergent prostate neuroendocrine carcinoma, continuation of androgen deprivation therapy is permitted.\n  * Any herbal or prescription\u002Fnon-prescription medications known to inhibit membrane transporters P-glycoprotein (P-gp) and\u002For breast cancer resistance protein (BCRP) within 7 days prior to the first dose of study treatment.\n\nAny herbal or prescription\u002Fnon-prescription medications known to be moderate or strong inhibitors of cytochrome P450 3A (CYP3A) enzymes (including but not limited to clarithromycin, itraconazole, ketoconazole) within 7 days prior to the first dose of study treatment.\n\n* Any herbal or prescription\u002Fnon-prescription medications known to be moderate or strong inducers of CYP3A enzymes within 28 days prior to first dose of study treatment.\n* Subjects who have reached the limit dose of prior treatment with cardiotoxic drugs such as other anthracyclines.\n* Major surgical procedures within 28 days prior to first dose of study treatment.\n\nTreatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study treatment. Inactive vaccines (eg, non-live or non-replicating agent) and live viral non-replicating vaccines (eg, Jynneos for Monkeypox infection) within 3 days prior to first dose of study treatment.\n\n* Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.\n* Female subjects of childbearing potential unwilling to use protocol specified method of contraception see Appendix 5 (Section 11.5) during treatment and for an additional 60 days after the last dose of tarlatamab.\n* Female subjects who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab\n* Female subjects planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab\n* Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a serum or urine pregnancy test.\n* Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of tarlatamab.\n* Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab\n* Male subjects unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab Subject has known sensitivity or is contraindicated to any of the products or components to be administered during dosing\n* Subject likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures\n* History or evidence of any other clinically significant disorder, condition or disease","ALL","19 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a phase 2 single-arm, open-label clinical trial designed to evaluate the efficacy and safety of tarlatamab in patients with relapsed extrapulmonary neuroendocrine carcinoma (EPNEC) who have previously received platinum-based first-line chemotherapy. Participants will receive tarlatamab on Cycle 1 Day 1 (C1D1), Day 8 (C1D8), and Day 15 (C1D15), followed by administration every two weeks thereafter. No placebo control is included in this study.",[27,28,29],"Neuroendocrine Carcinomas (NEC)","Neuroendocrine Carcinoma of Pancreas","Neuroendocrine Carcinoma of Prostate",[31,32,33,34],"extrapulmonary neuroendocrine carcinoma","Tarlatamab","bispecific t-cell engager","DLL3","RECRUITING","2026-04-09",{"date":38,"type":39},"2026-04-13","ACTUAL",{"date":41,"type":39},"2025-09-02",{"date":43,"type":21},"2029-04-30",{"name":45,"class":46},"Inkeun Park","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":66,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100489405","phase-1-a-study-of-peluntamig-pt217-in-patients-with-neuroendocrine-carcinomas-expressing-dll3-the-skybridge-study-100489405","NCT05652686","A Study of Peluntamig (PT217) in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)","An Open-label, Multicenter, Dose Escalation, and Dose Expansion Phase 1\u002F2 Study With Peluntamig (PT217) Followed by a Key ChemotherapY and\u002For Checkpoint Inhibitor ComBination in Patients With NeuRoendocrIne Carcinomas That Are Known to be DLL3 expressinG CancErs (SKYBRIDGE)","Key Inclusion Criteria\n\n1. NECs that have transformed from NSCLC are not eligible. Part A: Patients with histologically or cytologically confirmed unresectable advanced or metastatic small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), or extrapulmonary neuroendocrine carcinoma (EP-NEC). Patients with tumors that are of mixed histology are eligible only if neuroendocrine carcinoma\u002Fsmall cell cancer component is predominant and represents at least 50% of the overall tumor tissue. Patients with well differentiated grade 3 neuroendocrine tumors (Ki-67 ≥ 55%) may be considered if their tumors are DLL3 positive.\n\n   Patients may have progressed after standard of care treatments (at least one line of platinum-based chemotherapy with or without immune checkpoint inhibitor for SCLC patients) or other treatment options, or for whom treatment is not available or not tolerated.\n\n   Part B: Patients must meet the same criteria in Part A, C or D.\n\n   Part C:\n\n   • Cohort C1: patients with LCNEC or EP-NEC eligible for first-line (1L) CE treatment. SCLC patients who have relapsed on a 1L treatment (including platinum-based therapy with or without ICI) but remain platinum sensitive (defined as patients who experienced disease progression at least 90 days after their last platinum based chemotherapy) and are eligible for CE treatment rechallenge.\n\n   Cohort C2: patients with SCLC, LCNEC and EP-NEC eligible for second line (2L) paclitaxel treatment.\n\n   Part D:\n   * Cohort D1: will include 2L patients with SCLC, LCNEC, pr EP-NEC that have progressed\u002Frelapsed from their first-line treatment that may have included an ICI.\n   * Cohort D2: will include 1L ES-SCLC patients that have completed their induction therapy with carboplatin and etoposide plus atezolizumab and are eligible to continue with atezolizumab. These patients must have either stable disease or partial response prior to enrollment.\n   * Cohort D3: will include 1L ES-SCLC patients that are treatment naïve or have received C1D1\u002F2\u002F3 and are eligible for treatment with CE plus atezolizumab.\n2. Able to provide a formalin fixed, paraffin embedded (FFPE) tumor tissue sample (preferably a newly acquired biopsy, or if not possible, archival tissue) to be assessed for DLL3 expression and other biomarkers.\n3. ECOG performance status of 0 or 1.\n4. Adequate organ function confirmed at screening and within 72 hours of initiating C1D1 of Peluntamig (PT217) treatment.\n\nKey Exclusion Criteria\n\n1. Women who are pregnant or lactating.\n2. Women of child-bearing potential (WOCBP) who do not use adequate birth control.\n3. Autoimmune disease requiring systemic treatment within the past twelve months.\n4. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2, and excluding ICIs) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment with Peluntamig (PT217).\n5. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications (≥ 10 mg prednisone, or equivalent) within 14 days prior to study drug Peluntamig (PT217), or anticipation of need for systemic immunosuppressive medication during study drug Peluntamig (PT217).\n6. Patients who have experienced Grade ≥ 3 immune-related events, such as (non-infectious) pneumonitis, interstitial lung disease, myocarditis.\n7. Treatment with therapeutic oral or i.v. antibiotics within 2 weeks prior to initiation of study treatment with Peluntamig (PT217).\n8. Patients with untreated brain or central nervous system (CNS) metastases or brain\u002FCNS metastases that have progressed.\n\n   Note: Patients with treated brain metastases that are off corticosteroids and have been clinically stable for 14 days are eligible for treatment.\n9. Impaired cardiac function or significant diseases.\n10. For Part D only, uncontrolled hypercalcemia.\n11. For Part D only, significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n12. Prior hemolytic anemia or Evans Syndrome in the last 3 months.\n13. Patients who have Grade ≥ 3 neuropathy.\n14. Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants .\n\nAdditional criteria may apply.","18 Years",{"count":56,"type":21},203,[58,24],"PHASE1","This is a first-in-human, Phase 1\u002F2, open-label, dose escalation, dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Peluntamig (PT217) as a monotherapy and in combination with chemotherapy.",[61,62,63,64,27,65],"Small Cell Lung Cancer (SCLC)","Large Cell Neuroendocrine Cancer (LCNEC)","Neuroendocrine Prostate Cancer (NEPC)","Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)","Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)",[34,67,68,69,70,71,72,73,74,75,76,77,78,79,80],"DLL3 expressing tumors","Lung cancer","SCLC","LCNEC","NEPC","GEP-NEC","Small Cell Lung Cancer","Large cell neuroendocrine cancer","Neuroendocrine prostate cancer","Gastroenteropancreatic neuroendocrine carcinoma","Neuroendocrine carcinoma","Extrapulmonary neuroendocrine carcinoma","EP-NEC","CD47","2025-09-18",{"date":83,"type":39},"2025-09-23",{"date":85,"type":39},"2023-09-05",{"date":87,"type":21},"2028-08",{"name":89,"class":90},"Phanes Therapeutics","INDUSTRY",12,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":105,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":4},"100604938","phase-2-sintilimab-in-combination-with-surufatinib-and-temozolomide-in-the-advanced-neuroendocrine-carcinoma-100604938","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.","75 Years",{"count":101,"type":21},32,[24],"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).",[27],[106,107,108,109,110],"Surufatinib","Temozolomide","Sintilimab","Neuroendocrine carcinomas","Prospective observational study","NOT_YET_RECRUITING","2025-09-03",{"date":114,"type":39},"2025-09-04",{"date":116,"type":21},"2025-10",{"date":118,"type":21},"2027-12",{"name":120,"class":46},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":143},"100594061","phase-4-a-irinotecan-liposome-trial-of-in-advanced-neuroendocrine-carcinoma-100594061","NCT07014540","A Irinotecan Liposome Trial of in Advanced Neuroendocrine Carcinoma","Clinical Study on the Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU\u002FLV in the Treatment of Advanced Neuroendocrine Carcinoma","Inclusion Criteria:\n\n1. Age≥18 years\n2. Advanced poorly differentiated neuroendocrine carcinoma diagnosed by histopathology, grade 3 (PD-EP-NEC, G3), after excluding the primary lesion in the lungs, cancers with unknown primary lesions are also allowed\n3. Subjects who have failed at least the first-line standard treatment regimen in the past, recurrence within 6 months after the end of (new) adjuvant therapy is regarded as a failure of first-line treatment\n4. Has not received irinotecan treatment\n5. At least one measurable lesion，according to RECIST 1.1\n6. ECOG 0\\~1\n7. The expected survival ≥3 months\n8. Having appropriate organ functions is defined as follows: those who need to complete hematological and blood biochemistry tests within 14 days before enrollment and meet the following conditions\n\n   1. The absolute neutrophil count (ANC) was ≥1.5\\*10\\^9\u002FL\n   2. Hemoglobin ≥90g\u002FdL\n   3. Platelets (PLT) ≥100\\*10\\^9\u002FL\n   4. Total bilirubin \\\u003C1.5 times the upper limit of normal value (ULN)\n   5. Liver function Index (AST\u002FALT) chemical test \\\u003C2.5 times the upper limit of normal value (ULN)\n   6. Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCr) ≥ 60mL\u002Fmin, negative urine protein. For patients with urine protein ≥2+ at baseline, 24-hour urine collection should be conducted and the protein content in urine within 24 hours should be less than 1g\n9. Patients with brain metastases enrolled in the group must meet the following conditions: (1) No clinical symptoms related to brain metastases and no need for systemic corticosteroids or anticonvulsant drugs for treatment; (2) No risk of cerebral hemorrhage\n10. Male, female of childbearing age and their partners voluntarily adopted contraceptive measures considered effective by the researchers during the treatment and for at least three months after the last use of the study drug\n11. Be able to understand and voluntarily sign the written informed consent form, which must be signed before carrying out the research procedures specified in any trial\n12. Subjects fully understood and voluntarily participated in this study\n\nExclusion Criteria:\n\n1. Within 28 days before the first treatment with the study drug, biological therapy, chemotherapy, surgical treatment, radiotherapy (PRRT requires 56 days), immunotherapy and other clinical study drug treatments (except placebo) were received; Small molecule drug treatment was received within 5 half-lives (for example, 6 days for everolimus and 10 days for sunitinib)\n2. Adverse events caused by previous anti-tumor treatment (excluding alopecia) have not yet recovered (according to CTCAE. Version 5.0, with a severity level higher than level 1\n3. Known active, uncontrollable or symptomatic central nervous system metastases, cancerous meningitis or leptomeningeal diseases suggested by clinical symptoms, cerebral edema and\u002For progressive tumor growth. Patients with a history of central nervous system metastasis or spinal cord compression, if they have received definite local treatments (such as radiotherapy, stereotactic surgery) and are clinically stable, and have stopped anticonvulsants and steroids for at least 4 weeks before enrollment, are eligible to be enrolled in this study\n4. Known hemorrhagic constitution or disease\n5. Patients with any severe and\u002For uncontrolled diseases\n\n   1. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months, and severe uncontrolled arrhythmia;\n   2. Active or uncontrolled severe infections;\n   3. Liver diseases such as liver cirrhosis, decompensated liver disease, and chronic hepatitis (i.e., positive for quantifiable HBV-DNA and\u002For HbsAg, and quantifiable HCV-RNA);\n6. Hypertension that cannot be controlled by medication is defined as a systolic blood pressure of ≥140mmHg or a diastolic blood pressure of ≥90mmHg\n7. There have been or are currently active ulcers of the stomach and duodenum, ulcerative colitis and other digestive tract diseases, or unresected digestive tract tumors with active bleeding, or other conditions that may cause digestive tract bleeding or perforation as determined by the researcher\n8. Severe diarrhea (According to the NCI-CTCAE5.0 standard, grade 2 and above diarrhea: Compared with the baseline, the frequency of defecation increases by ≥4 times per day; Moderate to severe increase in the discharge from the stoma opening; Restrictions on daily living activities\n9. Those who have a history of deep vein thrombosis, pulmonary embolism or other serious thromboembolism within 6 months before the first administration of the study drug\n10. Subjects with serious injuries or non-healing wounds, or with unhealed fractures\n11. Combined with uncontrollable systemic diseases (such as unstable angina pectoris, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, history of severe pericardial diseases and other cardiovascular diseases；uncontrollable hypertension, diabetes, etc.\n12. Those who are known to be allergic or intolerant to therapeutic drugs or their excipients\n13. Patients who participated in other interventional clinical studies simultaneously\n14. Those with other malignant tumors requiring treatment\n15. The researchers judged the patients who were not suitable to participate in this study",{"count":129,"type":21},45,[131],"PHASE4","To explore the efficacy and safety of irinotecan liposome injection combined with 5-FU\u002FLV in the treatment of advanced neuroendocrine carcinoma (NEC)",[27],"2025-06-03",{"date":136,"type":39},"2025-06-11",{"date":138,"type":21},"2025-06-20",{"date":140,"type":21},"2027-12-31",{"name":142,"class":46},"Beijing GoBroad Hospital",1]