[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580508":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":46,"collaborators":22,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":22,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":22,"enrollmentInfo":59,"targetDuration":22,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":22,"overallStatus":32,"whyStopped":22,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Anhui Provincial Cancer Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tislelizumab plus chemo and radiotherapy","EXPERIMENTAL","Experimental treatment\n\n1. Drug: Tislelizumab, Carboplatin \u002FCisplatin, Etoposide\n\n   • Tislelizumab (200 mg IV Q3W) in combination with chemotherapy consisting of etoposide (100 mg\u002Fm² IV Days 1-3 of each 21-day cycle) and platinum (cisplatin 75 mg\u002Fm² IV Q3W or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 IV Q3W) for 4 cycles. Then maintenance consists of Tislelizumab Q3W and will continue until disease progression, loss of clinical benefit, unacceptable toxicity, or withdrawal of informed consent，up to 2 years.\n2. Radiotherapy:\n\n   * Induction therapy stage LDRT: lung lesions, 15Gy\u002F5f;\n   * Maintenance therapy phase SBRT: The main residual lesions evaluated by the investigators, 30Gy\u002F5f；\n\nControl group: This study refers to the Phase III RATIONALE-312 study, the reported median PFS was 4.7 months in patients treated with Tislelizumab combined with chemotherapy. This regimen has been recommened as 1L treatment for ES-SCLC in the CSCO guidelines.",[13],"Drug: Tislelizumab, Carboplatin \u002FCisplatin, Etoposide",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Tislelizumab, Carboplatin \u002FCisplatin, Etoposide","Induction therapy stage LDRT: lung lesions, 15Gy\u002F5f; Maintenance therapy phase SBRT: The main residual lesions evaluated by the investigators, 30Gy\u002F5f；",[9],[21],"radiotherapy",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Shuanghu Yuan, PhD","CONTACT","0551-62894008","yuanshuanghu@sina.com",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Anhui Cancer Hospital","RECRUITING","Hefei","Anhui","230031","China","CN",{"type":39,"coordinates":40},"Point",[41,42],117.28083,31.86389,{"lat":42,"lon":41},[45],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Shuanghu Yuan","Professor","100580508","phase-2-tislelizumab-combined-with-chemotherapy-and-relayed-radiotherapy-in-first-line-treatment-of-es-sclc-100580508",false,"NCT06838208","Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in First-line Treatment of ES-SCLC","Efficacy and Safety of Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in the First-line Treatment of Extensive Small Cell Lung Cancer: a Prospective, Multicenter, Phase II Clinical Study","Inclusion Criteria:\n\n1. Age≥18 years old, male or female, signed Informed Consent Form (ICF);\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n3. Histologically or cytologically confirmed ES-SCLC;\n4. No prior systemic treatment for ES-SCLC;\n5. At least one measurable (RECIST 1.1) chest lesion capable of 15Gy\u002F5f irradiation;\n6. Adequate hematologic and end organ function;\n\nExclusion Criteria:\n\n1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis;\n2. Prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-PD-1), anti-PD-L1, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibody;\n3. Was administered a live vaccine ≤ 4 weeks before treatment;\n4. Active autoimmune diseases or history of autoimmune diseases that may relapse;\n5. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before treatment;\n6. With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;\n7. Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to treatment, including but not limited to tuberculosis infection;\n8. Received therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to starting treatment;","ALL","18 Years",{"count":60,"type":61},56,"ESTIMATED","INTERVENTIONAL",[64],"PHASE2","To explore the efficacy and safety of Tislelizumab combined with chemotherapy and relayed radiotherapy in the first-line treatment of extensive small cell lung cancer",[67],"Extensive-stage Small Cell Lung Cancer (ES-SCLC)","2025-09-18",{"date":70,"type":71},"2025-09-24","ACTUAL",{"date":73,"type":71},"2025-02-25",{"date":75,"type":61},"2028-04-01",{"name":5,"class":6},1]