[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572950":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":56,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Guangzhou Institute of Respiratory Disease","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Irinotecan liposome (II)+adebrelimab+carboplatin","EXPERIMENTAL","The patient received treatment with Irinotecan liposome (II), adebrelimab, and carboplatin.",[13],"Drug: Irinotecan liposome (II) combined with adebrelimab and carboplatin",{"label":15,"type":6,"description":16,"interventionNames":17},"etoposide+adebrelimab+carboplatin","The patient received treatment with etoposide, adebrelimab, and carboplatin.",[18],"Drug: etoposide combined with adebrelimab and carboplatin",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Irinotecan liposome (II) combined with adebrelimab and carboplatin","Irinotecan liposome (II) + adebrelimab + carboplatin",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"etoposide combined with adebrelimab and carboplatin","etoposide + adebrelimab + carboplatin",[15],[31],{"name":32,"affiliation":33,"role":34},"Chengzhi Zhou, Doctor","Guangzhou Institute of Respiratory Disease (Responsible Party)","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","13560351186","doctorzcz@163.com",[41],{"facility":33,"status":42,"city":43,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Guangzhou","510120","China","CN",{"type":48,"coordinates":49},"Point",[50,51],113.25,23.11667,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":38,"phoneExt":25,"email":39},"Chengzhi Zhou",{"type":34,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Zhou Chengzhi","doctor","100572950","phase-2-irinotecan-liposome-ii-or-etoposide-combined-with-adebrelimab-and-carboplatin-in-the-treatment-of-es-sclc-100572950",false,"NCT06739928","Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC","A Safety and Efficacy Evaluation Study of Irinotecan Liposome (II) or Etoposide Combined With Adebrelimab and Carboplatin in the Treatment of ES-SCLC","Inclusion Criteria:\n\n* Pathologically confirmed small cell lung cancer (SCLC), staged as extensive-stage SCLC (ES-SCLC) according to the VALG staging system;\n* No prior systemic treatment received;\n* At least a 6-month interval between the last treatment (radiation therapy and chemotherapy) and diagnosis of extensive-stage SCLC;\n* Showing at least one target lesion (RECIST 1.1) that has not been previously irradiated;\n* Male or female patients aged ≥18 and ≤70 years;\n* ECOG performance status (PS) score of 0 or 1;\n* Life expectancy of ≥12 weeks;\n* Adequate organ function: (1) Hematologic: WBC ≥ 3.0 × 10⁹\u002FL, ANC ≥ 1.5 × 10⁹\u002FL, PLT ≥ 100 × 10⁹\u002FL, HGB ≥ 9.0 g\u002FdL.(2) Hepatic function: AST ≤ 2.5 × ULN, ALT ≤ 2.5 × ULN, liver metastases allowed if ALT and AST ≤ 5 × ULN, TBIL ≤ 1.5 × ULN (except for Gilbert's syndrome, where total bilirubin ≤ 3.0 mg\u002FdL),(3) Renal function: Cr ≤ 1.5 × ULN or CrCl ≥ 50 mL\u002Fmin, (4) Coagulation: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN;\n* Agreement to use an appropriate contraceptive method from the first dose of the study treatment until 6 months after the last dose of the study treatment. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment;\n* The patient must have fully understood the study and voluntarily consent to participate by signing the informed consent form (ICF).\n\nExclusion Criteria:\n\n* Histologically or cytologically confirmed mixed small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC);\n* Previous treatment with immune checkpoint inhibitors, or treatment with irinotecan or other DNA topoisomerase inhibitors;\n* Use of a strong CYP3A4 inducer within 2 weeks prior to the first dose of the investigational drug, or a strong CYP3A4 inhibitor or UGT1A1 inhibitor within 1 week prior to the first dose;\n* Presence of clinically symptomatic brain metastasis, leptomeningeal metastasis, or spinal cord compression;\n* Hematologic disorders, including but not limited to lymphoma, acute or chronic leukemia, multiple myeloma, aplastic anemia, myelodysplastic syndrome, etc;\n* Clinically symptomatic third-space fluid accumulation, such as pericardial effusion, pleural effusion, or ascites that cannot be controlled by drainage or other treatments;\n* Active, known, or suspected autoimmune disease;\n* Use of corticosteroids (doses\\> 10 mg\u002Fday of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of the study drug;\n* Receipt of live vaccines or planned vaccination with a live vaccine within 4 weeks prior to the first dose of the study drug;\n* Interstitial lung disease, drug-induced pneumonia, radiation-induced pneumonia requiring steroid treatment, or clinically symptomatic active pneumonia, or severe pulmonary dysfunction;\n* Active tuberculosis or a history of active tuberculosis within 48 weeks prior to screening, regardless of whether it was treated;\n* Any toxicity from previous anticancer therapy, that has not resolved to grade ≤1 (according to CTCAE v5.0) prior to the first dose of the investigational drug;\n* Underwent a minor surgery (including catheter placement) within 48 hours prior to the first dose of the study drug;\n* Presence of uncontrolled cardiovascular symptoms or diseases;\n* Hypersensitivity to the investigational drug or its excipients;\n* A history of any other malignancy within 5 years prior to the first dose of the study drug, except for adequately treated non-melanoma skin cancer or in situ carcinoma;\n* A history of psychiatric disorders, alcohol abuse, drug abuse, or substance misuse;\n* HBsAg-positive and HBV DNA levels exceeding the upper limit of normal, or HCV-positive (HCV RNA or HCV Ab indicating acute or chronic infection); a history of HIV-positive status or acquired immunodeficiency syndrome (AIDS);\n* Received any other investigational drug or participated in another interventional clinical trial within 4 weeks prior to signing the informed consent form (ICF);\n* A history of allogeneic bone marrow transplantation or solid organ transplantation;\n* Any other factors as determined by the investigator.","ALL","18 Years","70 Years",{"count":70,"type":71},120,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","This study is a prospective, randomized, parallel, multicenter phase II study aimed at evaluating the efficacy and safety of irinotecan liposome (II) or etoposide combined with adebrelimab and carboplatin as first-line treatment for extensive stage small cell lung cancer. The primary endpoint of the study was the 1-year overall survival rate.",[77],"Small Cell Lung Cancer Extensive Stage",[79,80,81,82,83],"ES-SCLC","extensive stage-small cell lung cancer","adebrelimab","Irinotecan liposome (II)","zhou chengzhi","2024-12-13",{"date":86,"type":87},"2024-12-18","ACTUAL",{"date":89,"type":71},"2025-01-01",{"date":91,"type":71},"2027-12-30",{"name":5,"class":6},1]