[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extrapulmonary-neuroendocrine-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extrapulmonary-neuroendocrine-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,62],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053826","phase-1-autologous-b7-h3-chimeric-antigen-receptor-t-cells-in-previously-treated-extensive-stage-small-cell-lung-cancer-with-recurrent-or-refractory-disease-100053826",false,"NCT07509034","Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease","A Phase I Study to Assess the Safety and Antitumor Activity of Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease","* INCLUSION CRITERIA:\n* Age \\>=18 years old.\n* Histologically confirmed small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancers (EP-NEC) that has recurred following or is refractory to first-line therapy. Note: small cell cancers of non-lung primary sites are also eligible.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2.\n* Pulse oximetry \\>= 90 percent on room air.\n* Aspartate Transferase (AST) \\\u003C 3 X institutional upper limit of normal (ULN). Note: in case of liver metastases 5 X ULN is acceptable.\n* Alanine Aminotransferase (ALT) \\\u003C 3 X institutional ULN. Note: in case of liver metastases \\\u003C= 5 X ULN is acceptable.\n* Total bilirubin \\\u003C=2 X institutional ULN.\n* Creatinine \\\u003C=1.5 X institutional ULN.\n* Absolute Neutrophil Count (ANC) \\>= 750\u002FmcL.\n* Platelet count \\>= 75,000\u002FmcL.\n* An absolute lymphocyte count (ALC) \\>=300\u002FmcL and CD3 plus cell count \\>=150\u002FmcL.\n* Normal cardiac ejection fraction as defined by \\>= 45 percent by echocardiogram (ECHO) at screening.\n* At least 1 measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 that has not been previously irradiated.\n* Recovered from acute toxic effects of all prior cancer therapy to Grade \\\u003C2 per Common Terminology Criteria for Adverse Events (CTCAE) v.6.0 at least one week before apheresis.\n* The following criteria must be met prior to apheresis:\n\n  * Chemotherapy and biologic\u002Ftargeted agents:\n\n    * \\>=14 days since the last dose of standard myelosuppressive chemotherapy.\n    * \\>= 7 days since the completion of biologic agent, targeted agent, or tyrosine kinase inhibitor therapy.\n    * \\>= 3 weeks or 5 half-lives (whichever is shorter) since prior therapy with a monoclonal antibody.\n  * Radiotherapy:\n\n    * \\>= 1 week since the last radiotherapy session.\n    * No washout period required for palliative radiation to non-target lesions.\n    * \\>= 3 weeks since hepatic radiation, chemoembolization, and\u002For radiofrequency ablation.\n  * Steroids and immunosuppressive therapy:\n\n    * Corticosteroids: \\>= 2 weeks since the therapeutic doses (\\> 0.5 mg\u002Fkg\u002Fday prednisone or equivalent). Note: Inhaled or topical steroids are not exclusionary.\n    * Physiologic replacement doses (up to 5 mg\u002Fday prednisone equivalent) are allowed and can be adjusted based on participant s BMI if warranted.\n    * \\>= 2 weeks since the other immunosuppressive medication (e.g., calcineurin inhibitors, methotrexate, rapamycin, thalidomide, etc.).\n  * Anti-PD-1 and any investigational therapies:\n\n    * \\>= 2 weeks since Anti-PD-1 monoclonal antibody therapy.\n    * \\>= 2 weeks or 5 half-lives of the investigational product (whichever is shorter) since any investigational treatment or clinical trial participation.\n  * Other criteria:\n\n    * 72 hours since small molecule tyrosine kinase inhibitors (e.g., EGFR inhibitors), PARP inhibitors, or KRAS G12C inhibitors.\n* Individuals of childbearing potential (IOCBP) must agree to use highly effective contraception (hormonal, intrauterine device \\[IUD\\], abstinence, surgical sterilization) at the study entry and up to 12 months after the last dose of combined chemotherapy.\n\nNote: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n\n* Individuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 7 months after the last dose of study drugs. We also will recommend individuals able to father a child with partners of childbearing potential ask partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Individuals able to father a child must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last dose of the study drug(s).\n* Ability of the participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of anaphylactic reactions attributed to anti-B7-H3 antibodies or compounds of similar chemical or biologic composition to autologous B7-H3 CAR T cells, cyclophosphamide, fludarabine, or other agents used in this study.\n* Infection exposure with the human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) as defined below:\n\n  * Positive serology for HIV.\n  * Active HBV infection as demonstrated by test for hepatitis B surface antigen (HBsAg).\n  * Positive serology for HCV.\n* Prior gene therapy using an integrating vector (except for autologous B7-H3 CAR T cells retreatment).\n* History of any previous allogeneic hematopoietic stem cell transplant.\n* Presence of fungal, bacterial, viral, or other infection is permitted if responding to active treatment.\n* Central Nervous System (CNS) disorder such as cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement that may impair the ability to evaluate neurotoxicity.\n* Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test in IOCBP at screening.\n* Uncontrolled intercurrent illness or medical condition(s) evaluated by medical history, physical exam, electrocardiogram (ECG) or situations that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study.","ALL","18 Years","120 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Background:\n\nSmall cell lung cancer (SCLC) is the deadliest form of lung cancer. Extrapulmonary neuroendocrine cancer (EPNEC) is a similar type of cancer that develops anywhere other than the lungs. EPNEC is also deadly. B7-H3 is a protein often found in SCLC and EPNEC tumor cells. Researchers can modify a person s own T cells, or immune cells, to target B7-H3. When these modified T cells are returned to the body-a treatment called B7-H3 chimeric antigen receptor (CAR) T cell therapy-they may help kill cancer cells.\n\nObjective:\n\nTo test B7-H3 CAR T cell therapy in people with SCLC or EPNEC.\n\nEligibility:\n\nPeople aged 18 years and older with SCLC or EPNEC that either did not respond or returned after treatment.\n\nDesign:\n\nParticipants will be screened. They will have blood tests and tests of their heart function. They will have imaging scans.\n\nParticipants will undergo apheresis: Blood will be taken from the body through a needle. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different needle. The collected T cells will be altered to make them attack cells with B7-H3.\n\nParticipants will be in the hospital for at least 15 days. They will receive chemotherapy drugs to prepare their body for the treatment. These drugs will be given through a tube attached to a needle inserted into a vein.\n\nThe modified T cells will be infused through a vein. Participants will remain in the hospital until they are well enough to go home.\n\nFollow-up visits will continue for 15 years....",[27,28,29,30],"Extensive-Stage Small Cell Lung Cancer","Extrapulmonary Neuroendocrine Carcinoma","Recurrent or Refractory","Solid Tumors",[32,33,34,35],"B7-H3","CAR-T","Phase I","Immunotherapy","NOT_YET_RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":21},"2026-07-16",{"date":44,"type":21},"2031-01-30",{"name":46,"class":47},"National Cancer Institute (NCI)","NIH",1,{"id":50,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":25,"conditions":53,"keywords":54,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":61,"locationsCount":48},"100632080",{"count":20,"type":21},[24],[27,28,29,30],[32,33,34,35],"2026-07-01",{"date":57,"type":40},"2026-07-02",{"date":59,"type":21},"2026-07-07",{"date":44,"type":21},{"name":46,"class":47},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":48},"100632200","phase-2-a-phase-ii-study-of-benmelstobart--anlotinib--chemotherapy-as-first-line-treatment-for-lcnec-and-ep-nec-100632200","NCT07510594","A Phase II Study of Benmelstobart + Anlotinib + Chemotherapy as First-Line Treatment for LCNEC and EP-NEC","A Single-Center, Single-Arm, Phase II Study of Benmelstobart Combined With Anlotinib and Chemotherapy as First-Line Treatment for Large-Cell Neuroendocrine Carcinoma of the Lung and Extrapulmonary Neuroendocrine Carcinoma","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed metastatic LCNEC or EP-NEC (per AJCC 9th Edition);\n2. No prior systemic treatment for locally advanced or metastatic LCNEC or EP-NEC; For patients who have received adjuvant chemo\u002Fradiotherapy, neoadjuvant chemo\u002Fradiotherapy for non-metastatic disease with curative intent, or definitive chemoradiotherapy for locally advanced disease, the interval from the end of chemotherapy, radiotherapy, or chemoradiotherapy to the diagnosis of metastatic NEC must be at least 6 months (calculated from the end date of the last chemotherapy cycle or the end date of the last radiotherapy);\n3. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; Lesions that have received prior radiotherapy can be considered measurable only if there is clear progression after radiotherapy and they are not the only lesion;\n4. Aged 18-75 years;\n5. ECOG Performance Status 0-1;\n6. Life expectancy ≥3 months;\n7. Sufficient hematological and organ function, meeting the following criteria:\n\n   1. Hematology (no blood transfusion or blood products within 14 days, no correction with G-CSF or other hematopoietic stimulants): Absolute Neutrophil Count (ANC) ≥1.5×10⁹\u002FL; Platelet Count (PLT) ≥100×10⁹\u002FL; White Blood Cell (WBC) Count ≥3×10⁹\u002FL;\n   2. Biochemical tests:\n\n      Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5×Upper Limit of Normal (ULN), or ≤5×ULN in patients with liver metastasis; Total Bilirubin (TBIL) ≤1.5×ULN, or ≤3×ULN in patients with Gilbert's syndrome; Creatinine (Cr) ≤1.5×ULN or Creatinine Clearance (CCr) ≥50mL\u002Fmin;\n   3. Coagulation function:\n\n      Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR), or Prothrombin Time (PT) ≤1.5×ULN;\n   4. Doppler ultrasound assessment:\n\n   Left Ventricular Ejection Fraction (LVEF) ≥50%;\n8. Women and men of childbearing potential must agree to use contraceptive measures (e.g., intrauterine device \\[IUD\\], contraceptive pills, or condoms) during the study treatment period and within 6 months after the last dose of study medication; Women must have a negative serum pregnancy test within 7 days before study randomization and must not be breastfeeding;\n9. Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Patients with brain metastasis and\u002For carcinomatous meningitis (excluding asymptomatic patients or patients with stable condition who have no imaging evidence of new\u002Fenlarged central nervous system metastasis for at least 2 weeks after brain metastasis treatment and have discontinued steroids or anticonvulsants for at least 14 days before the study; If active or new untreated asymptomatic central nervous system metastasis is detected during the screening phase, subjects must receive radiotherapy, or have no imaging evidence of new\u002Fenlarged brain metastasis for at least 2 weeks without treatment);\n2. Prior use of anti-angiogenic drugs such as Anlotinib, Apatinib, Bevacizumab, or immunotherapeutic drugs targeting PD-1, PD-L1, etc.;\n3. History of other malignant tumors within 5 years (except cured carcinoma in situ of the cervix or basal cell carcinoma of the skin);\n4. Factors affecting oral drug administration (dysphagia, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.);\n5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n6. Spinal cord compression not cured or relieved by surgery and\u002For radiotherapy, or no clinical evidence of stable condition for ≥1 week after treatment of previously diagnosed spinal cord compression before randomization;\n7. Imaging (Computed Tomography \\[CT\\]\u002FMagnetic Resonance Imaging \\[MRI\\]) showing tumor invasion of large blood vessels or unclear boundary with large blood vessels;\n8. Patients with imaging evidence of tumor invasion around major blood vessels, or judged by the investigator to have a high risk of tumor invading major blood vessels leading to fatal massive hemorrhage during the subsequent study period;\n9. History of severe bleeding tendency or coagulation dysfunction, including but not limited to: clinically significant hemoptysis (hemoptysis \\>1 tablespoon per day) within 3 months before enrollment; or bleeding symptoms or bleeding tendency of significant clinical significance within 4 weeks before randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer (including gastrointestinal perforation and\u002For fistula, except for patients with gastrointestinal perforation or fistula who have undergone surgical resection and are eligible for enrollment), unhealed wounds, ulcers, or fractures;\n10. Unresolved treatment-related toxicity (\\>Grade 1) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (except alopecia);\n11. Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days before randomization;\n12. Arterial\u002Fvenous thromboembolic events (such as cerebrovascular accident \\[including transient ischemic attack\\], deep vein thrombosis, and pulmonary embolism) within 6 months before randomization;\n13. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose;\n14. Vaccination with prophylactic or attenuated vaccines within 28 days before the first dose;\n15. Severe allergic reaction to other monoclonal antibodies;\n16. History of psychotropic drug abuse that cannot be abstained from, or mental disorders;\n17. Any severe and\u002For uncontrolled disease:\n\n    1. Poorly controlled blood pressure (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg);\n    2. Grade II or above myocardial ischemia or myocardial infarction, arrhythmia (including corrected QT interval \\[QTc\\] ≥450ms in men and QTc ≥470ms in women); congestive heart failure with New York Heart Association (NYHA) Functional Class II-IV;\n    3. Active or uncontrolled severe infection (≥Grade 2);\n    4. Liver cirrhosis, active hepatitis (hepatitis B: positive hepatitis B surface antigen and hepatitis B virus deoxyribonucleic acid \\>ULN; hepatitis C: positive hepatitis C antibody and hepatitis C virus titer \\>ULN);\n    5. Human Immunodeficiency Virus (HIV) positive;\n    6. Poorly controlled diabetes (fasting blood glucose \\>10mmol\u002FL);\n    7. Urinary protein ≥++, and confirmed 24-hour urinary protein \\>1.0g;\n18. Participation in other clinical trials within 28 days before the study;\n19. Other conditions that increase the risk related to study participation or study drugs and are deemed by the investigator to make the patient unsuitable for enrollment.","75 Years",{"count":71,"type":21},48,[73],"PHASE2","To explore the Objective Response Rate (ORR) of Benmelstobart combined with Anlotinib and chemotherapy as first-line treatment for large-cell neuroendocrine carcinoma of the lung (LCNEC) and extrapulmonary neuroendocrine carcinoma (EP-NEC)",[76,28],"Large-Cell Neuroendocrine Carcinoma of the Lung","2026-04-01",{"date":79,"type":40},"2026-04-03",{"date":81,"type":21},"2026-05-01",{"date":83,"type":21},"2027-12-31",{"name":85,"class":86},"Tianjin Medical University Cancer Institute and Hospital","OTHER"]