[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655610":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":11,"studyPopulation":11,"armGroups":33,"interventions":39,"overallOfficials":11,"centralContacts":44,"locations":50,"responsibleParty":65,"collaborators":67,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":11,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":11,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":52,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Yantai Yuhuangding Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Progression Free Survival (PFS)",null,"Up to 36 months",{"measure":14,"description":11,"timeFrame":15},"Overall Survival (OS)","Up to 48 months",[17,19,21,23,25],{"measure":18,"description":11,"timeFrame":12},"6- and 12-month progression-free survival rates",{"measure":20,"description":11,"timeFrame":12},"Objective Response Rate (ORR)",{"measure":22,"description":11,"timeFrame":12},"Disease Control Rate (DCR)",{"measure":24,"description":11,"timeFrame":12},"Duration of Response (DoR)",{"measure":26,"description":11,"timeFrame":12},"Adverse Events (AEs)",{"allocation":28,"interventionModel":29,"interventionModelDescription":11,"primaryPurpose":30,"observationalModel":11,"timePerspective":11,"maskingInfo":31},"NA","SINGLE_GROUP","TREATMENT",{"masking":32,"maskingDescription":11,"whoMasked":11},"NONE",[34],{"label":35,"type":36,"description":11,"interventionNames":37},"Tislelizumab + Anlotinib","EXPERIMENTAL",[38],"Drug: Tislelizumab + Anlotinib",[40],{"type":41,"name":35,"description":42,"armGroupLabels":43,"otherNames":11},"DRUG","Tislelizumab 200 mg on Day 1 plus anlotinib 10 mg on Days 1-14 of each 3-week cycle.",[35],[45],{"name":46,"role":47,"phone":48,"phoneExt":11,"email":49},"Jinbo Ma","CONTACT","+86 133 3638 9127","yhdmajb@163.com",[51],{"facility":5,"status":52,"city":53,"state":54,"zip":11,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Yantai","Shandong","China","CN",{"type":58,"coordinates":59},"Point",[60,61],121.44081,37.47649,{"lat":61,"lon":60},[64],{"name":46,"role":47,"phone":48,"phoneExt":11,"email":49},{"type":66,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[68,71],{"name":69,"class":70},"BeiGene","INDUSTRY",{"name":72,"class":70},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","100655610","phase-2-a-phase-ii-study-of-tislelizumab-plus-anlotinib-consolidation-after-chemoradiotherapy-in-ls-sclc-100655610",false,"NCT07815223","A Phase II Study of Tislelizumab Plus Anlotinib Consolidation After Chemoradiotherapy in LS-SCLC","A Prospective, Single-Arm, Phase II Study of Tislelizumab Plus Anlotinib as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Progression After Concurrent or Sequential Chemoradiotherapy","Inclusion Criteria:\n\n1. Provide written informed consent and be willing and able to comply with study requirements and scheduled assessments;\n2. Be aged 18-75 years at the time of consent;\n3. Have an ECOG performance status of 0 or 1;\n4. Have histologically or cytologically confirmed small-cell lung cancer;\n5. Have radiologically confirmed limited-stage disease;\n6. Have achieved a complete response, partial response, or stable disease after concurrent or sequential chemoradiotherapy, according to RECIST version 1.1;\n7. Have a life expectancy of at least 3 months;\n8. Have adequate organ function.\n\nExclusion Criteria:\n\n1. Received systemic immunostimulatory agents, including interferons, interleukin 2, or tumour necrosis factor, within 4 weeks or five half-lives before the first dose of study treatment, whichever is longer; previous cancer vaccines are permitted;\n2. Received any traditional Chinese herbal medicine for cancer control within 14 days before the first dose;\n3. Required systemic corticosteroids equivalent to more than 10 mg per day of prednisone or other immunosuppressive treatment within 14 days before the first dose;\n4. Received a live vaccine within 4 weeks before the first dose; inactivated seasonal influenza vaccines are permitted, but live intranasal influenza vaccines are not;\n5. Underwent major surgery requiring general anaesthesia within 28 days before the first dose;\n6. Had previous allogeneic stem-cell or organ transplantation;\n7. Have clinically significant pericardial effusion;\n8. Have uncontrolled pleural effusion or ascites requiring drainage within 2 weeks before enrolment;\n9. Have active autoimmune disease or a history of autoimmune disease with a risk of recurrence;\n10. Have a history of interstitial lung disease or non-infectious pneumonitis, or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, or acute lung disease;\n11. Have a severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral treatment within 2 weeks before the first dose, including tuberculosis;\n12. Have had another active malignancy within 2 years before the first dose, except the cancer under investigation or definitively treated localised cancers, including resected basal-cell or squamous-cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast;\n13. Have untreated chronic hepatitis B, chronic HBV infection with an HBV DNA concentration of at least 500 IU\u002FmL (2500 copies\u002FmL), or active hepatitis C;\n14. Have a known history of HIV infection;\n15. Have clinically significant cardiovascular risk factors;\n16. Have unresolved toxicities from previous anticancer treatment that have not returned to baseline or stabilised, except adverse events unlikely to pose a safety risk, such as alopecia, neuropathy, or specified laboratory abnormalities;\n17. Have a history of severe hypersensitivity to monoclonal antibodies.","ALL","18 Years","75 Years",{"count":84,"type":85},20,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","This prospective, single-arm, phase II study aims to evaluate the efficacy and safety of tislelizumab plus anlotinib as consolidation therapy in patients with limited-stage small cell lung cancer (LS-SCLC) who have not progressed following concurrent or sequential chemoradiotherapy.",[91],"SCLC, Limited Stage",[93],"consolidation therapy","2026-09-07",{"date":96,"type":97},"2026-09-11","ACTUAL",{"date":99,"type":97},"2025-11-04",{"date":101,"type":85},"2029-12-31",{"name":5,"class":6},1]