[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Second Affiliated Hospital of Dalian Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100619792","phase-2-iparomlimab-and-tuvonralimab-injection-combined-with-chemotherapy-and-sequential-thoracic-radiotherapy-for-extensive-stage-small-cell-lung-cancer-100619792",false,"NCT07349225","Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy and Sequential Thoracic Radiotherapy for Extensive-Stage Small Cell Lung Cancer","A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy and Sequential Thoracic Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n1. For voluntary signing of the informed consent form, participants aged 18 to 75 years (inclusive), regardless of gender, are eligible\n2. Histologically or cytologically confirmed ES-SCLC (according to the Veterans Administration Lung Study Group \\[VALG\\] staging system)\n3. Expected survival ≥ 3 months\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1\n5. No prior systemic first-line therapy or immune checkpoint inhibitor treatment for ES-SCLC\n6. Prior treatment with curative-intent surgery and adjuvant therapy (e.g., radiotherapy or chemotherapy), with a treatment-free interval of at least 6 months between the last dose of chemotherapy\u002Fradiotherapy\u002Fchemoradiotherapy and the diagnosis of ES-SCLC\n7. According to RECIST v1.1 (Appendix 2), previously irradiated lesions can only be considered measurable if there is documented disease progression at that site after radiotherapy, and such lesions must not be the sole site of disease\n8. Laboratory test results must meet the following criteria prior to enrollment: a) Hematology: No blood transfusion or hematopoietic growth factor administration within 14 days before enrollment; white blood cell count (WBC) ≥3.0×10\\^9\u002FL; absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; platelets (PLT) ≥100×10\\^9\u002FL; hemoglobin (HGB) ≥9.0 g\u002FdL. b) Liver function: Non-liver metastasis subjects: Aspartate aminotransferase (AST) ≤2.5×ULN and alanine aminotransferase (ALT) ≤2.5×ULN. Liver metastasis subjects: ALT and AST ≤5×ULN; serum total bilirubin (TBIL) ≤1.5×ULN (except Gilbert syndrome, where TBIL ≤3.0 mg\u002FdL). c) Renal function: Serum creatinine ≤1.5×ULN or calculated creatinine clearance (CrCl) ≥50 mL\u002Fmin (using the Cockcroft-Gault formula in Appendix 3). d) Coagulation: International normalized ratio (INR) ≤1.5×ULN or activated partial thromboplastin time (APTT) ≤1.5×ULN (only for subjects not receiving anticoagulation therapy; subjects on stable-dose anticoagulants are eligible). e) Other tests confirming adequate cardiopulmonary function\n9. Male patients with reproductive potential or female patients of childbearing potential must use effective contraception (e.g., oral contraceptives, intrauterine devices, or barrier methods combined with spermicides) during the study and continue for 6 months after treatment completion\n10. For patients with HBV or HCV infection, the following criteria must be met: HBV-infected patients (HBsAg or HBV-DNA positive): Prior to the first treatment, HBV-infected patients must receive ≥3 days of guideline-recommended antiviral therapy with confirmed reduction in HBV-DNA levels upon retesting . Standard antiviral treatment must continue throughout the study period . HCV-infected subjects (HCVAb or HCV RNA positive): Must be in a stable condition as judged by the investigator. If already on antiviral therapy, treatment should be maintained during the study\n11. Good compliance and cooperation with follow-up\n\nExclusion Criteria:\n\n1. Patients with allergies or intolerance to the EP chemoradiotherapy regimen or any active\u002Fauxiliary components of the investigational drug\n2. Active or untreated central nervous system (CNS) metastases identified by computed tomography (CT) or magnetic resonance imaging (MRI) during screening or prior radiographic assessments\n3. Malignant effusions (pleural\u002Fascites\u002Fpericardial) refractory to prior interventions (Defined as significant reaccumulation requiring repeat drainage or other interventions within 2 weeks, accompanied by symptomatic worsening)\n4. Active autoimmune diseases , including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), inflammatory bowel disease (IBD), antiphospholipid syndrome, granulomatosis with polyangiitis (Wegener's), Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis (MS)\n5. Uncontrolled hypertension despite treatment with ≥1 antihypertensive agent(s) (Defined as systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg, based on the average of ≥2 BP readings, despite ongoing antihypertensive therapy. Adjustment of treatment to improve these parameters is permitted.)\n6. Moderate-to-severe pulmonary diseases that significantly impair lung function , including but not limited to interstitial lung disease (ILD), drug-induced pneumonitis, idiopathic pneumonia, or idiopathic pulmonary fibrosis (IPF)\n7. Patients with active tuberculosis infection confirmed by medical history or CT examination, or those with a history of active tuberculosis infection within 1 year prior to enrollment\n8. Severe infections within 4 weeks prior to initial treatment , including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia\n9. Severe cardiovascular or cerebrovascular diseases within 3 months prior to initial treatment , including myocardial infarction, cerebrovascular accident, unstable arrhythmia, or unstable angina\n10. History of allogeneic bone marrow transplantation or solid organ transplantation\n11. Prior treatment with immune checkpoint inhibitors (ICIs) , including but not limited to anti-PD-1, anti-PD-L1, or anti-CTLA-4 agents\n12. Use of systemic immunosuppressive therapy within 2 weeks prior to initial treatment , or anticipated need for systemic immunosuppressive therapy during the study treatment period\n13. Participation in any other interventional clinical study or use of any other investigational product within 4 weeks prior to signing the informed consent form\n14. History of abdominal or tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within 1 month prior to initial treatment\n15. Major vascular disease occurring within 3 months prior to initial treatment (e.g., aortic aneurysm requiring surgical repair)\n16. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study\n17. Positive for human immunodeficiency virus (HIV) antibody\n18. History of schizophrenia or psychotropic drug abuse\n19. Other factors considered by the investigator to make the subject unsuitable for participation in the study","ALL","18 Years","75 Years",{"count":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study will evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection in combination with Chemotherapy and Sequential Thoracic Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer.",[27],"ES-SCLC","NOT_YET_RECRUITING","2026-01-09",{"date":31,"type":32},"2026-01-16","ACTUAL",{"date":34,"type":21},"2026-01-31",{"date":36,"type":21},"2028-02-28",{"name":38,"class":39},"The Second Affiliated Hospital of Dalian Medical University","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":46,"targetDuration":4,"studyType":22,"phases":48,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":5},"100579166","phase-2-irinotecan-liposomeii-combined-with-ivonescimab-as-second-line-treatment-for-small-cell-lung-cancer--a-prospective-single-arm-multicenter-clinical-study-100579166","NCT06820762","Irinotecan Liposome(II) Combined With Ivonescimab as Second-line Treatment for Small Cell Lung Cancer : A Prospective, Single-arm, Multicenter Clinical Study","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Histologically or cytologically confirmed SCLC;\n3. Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;\n4. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;\n5. Life expectancy of ≥3 months;\n6. At least one measurable lesion is present according to the efficacy evaluation criteria for RECIST 1.1（Lesions that have received radiotherapy within 6 months prior to the first dose cannot be used as target lesions）\n7. No untreated central nervous system (CNS) metastases or CNS were stable for ≥1 month after treatment\n8. Have adequate organ function;\n9. All female must have had a negative serum pregnancy test within 72 hours of the first dosing and not be lactating, and study participants and their partners must use effective contraception during the trial and for 6 months after the last dosing of the trial drug.\n10. Able and willing to provide a written informed consent;\n\nExclusion Criteria:\n\n1. Known allergy to irinotecan hydrochloride liposome injection (II) and eboxizumab or drug excipients\n2. History of severe active autoimmune disease\n3. Participated in other drug studies within 4 weeks before enrollment\n4. Imaging during the screening period showed that the tumor surrounded important blood vessels or had significant necrosis and voids, and the investigators determined that entering the study would cause bleeding risk\n5. History of major illness within 1 year before the first medication\n6. History of esophageal and gastric varices, severe ulcers, unhealed wounds, abdominal fistula, intraperitoneal abscess, or acute gastrointestinal bleeding within 6 months prior to initial administration\n7. History of surgery or severe trauma within 4 weeks prior to initial dosing\n8. Evidence and history of severe bleeding tendency;\n9. Participants who had received or planned to receive a live vaccine within 4 weeks prior to the first study treatment\n10. Patients with other cancer in 3 years,exceptions are adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n11. History of alcohol abuse, psychotropic substance abuse or drug abuse. Other conditions considered unsuitable for this study by the investigator.",{"count":47,"type":21},40,[24],"This study will evaluate the efficacy and safety of irinotecan liposome(II) in combination with Ivonescimab as second line treatment for SCLC.",[51],"SCLC",[53],"SCLC，irinotecan liposome(II)，Ivonescimab","2025-02-05",{"date":56,"type":32},"2025-02-11",{"date":58,"type":21},"2025-02-28",{"date":60,"type":21},"2027-12-31",{"name":38,"class":39},""]