[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477376":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":26,"responsibleParty":34,"collaborators":38,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":25,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":25,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":66,"whyStopped":25,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"surgery group","EXPERIMENTAL","SHR-1316+chemotherapy+surgery",[13],"Combination Product: chemotherapy and SHR-1316(Adebrelimab) comnined with surgery or radiotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"radiotherapy group","ACTIVE_COMPARATOR","SHR-1316+chemotherapy+radiotherapy",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"COMBINATION_PRODUCT","chemotherapy and SHR-1316(Adebrelimab) comnined with surgery or radiotherapy","Induction treatment stage: SHR-1316(Adebrelimab)，20mg\u002Fkg,+Cisplatin 75mg\u002Fm2, d1+ etoposide 100mg\u002Fm2, d1,d2,d3, q3w, iv, 4 cycles. Patients who are able to receive surgery after assessed by two surgons would receive surgery or radiotherapy randomly. Adjuvant\u002F maintenance treatment stage: SHR-1316，20mg\u002Fkg, iv, q3w,up to 1 year",[15,9],null,[27],{"facility":28,"status":25,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Shanghai Pulmonary Hospital","Shang'ai","Shanghai Municipality","200433","China","CN",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Peng Zhang","associate professor of medicine",[39],{"name":40,"class":41},"Jiangsu HengRui Medicine Co., Ltd.","INDUSTRY","100477376","phase-3-the-efficiency-of-surgery-and-radiotherapy-after-shr-1316-adebrelimab-and-platinum-containing-doublet-induction-therapy-for-limited-stage-small-cell-lung-cancer-100477376",false,"NCT05496166","The Efficiency of Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer","Comparing the Efficiency Between Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer: a Randomized, Controlled, Open-label, Single-center Phase III Clinical Trial","Inclusion Criteria:\n\n* after signing informed consent;\n* Aged 18-70;\n* Histologically or cytologically confirmed SCLC, imaging examination and other confirmed limited-stage small cell lung cancer, and without previous treatment;\n* For clinical stage IIB-III, all patients should have clear lymph node pathology by EBUS to exclud occult lymph node metastasis.\n* Two thoracic surgeons assessed thar it would be able to achieve radical surgery or R0 resection after 4 cycles of treatment. Surgical approaches include lobectomy, sleeve resection and pneumonectomy\n* ECOG performance status score 0-1 points;\n* With a life expectancy of at least 12 weeks;\n* At least one measurable tumor\n* With normal Other major organs (liver, kidney, blood system, etc.) function:\n\nAbsolute neutrophil count (ANC) ≥1.5×109\u002FL, platelets ≥100×109\u002FL, hemoglobin ≥90 g\u002FL. Note: Patients should not receive blood transfusion or growth factor support within ≤ 14 days before blood collection during the screening period;\n\n\\- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × upper limit of normal (ULN); Activated partial thromboplastin time (APTT) ≤ 1.5×ULN; Serum total bilirubin ≤ 1.5×ULN (total bilirubin in patients with Gilbert syndrome must be \\\u003C3×ULN); Aspartate and alanine aminotransferase (AST and ALT) ≤2.5×ULN, or AST and ALT ≤5×ULN in patients with liver metastases\n\n* Female patients of childbearing potential must voluntarily use highly effective contraception during the study period until ≥ 120 days after the last dose of chemotherapy or SHR-1316, whichever is later, and have ≤ 7 days of urine or Serum pregnancy test results are negative;\n* Unsterilized male patients must voluntarily use highly effective contraception during the study period until ≥120 days after the last dose of chemotherapy or SHR-1316, whichever is later.\n\nExclusion Criteria:\n\n* Received any systemic anticancer therapy, including surgery, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, and experimental therapy;\n* Patients with other malignancies within five years prior to the start of the trial;\n* Combined with unstable systemic diseases, such as uncontrolled hypertension, severe arrhythmia, etc;\n* With active, known or suspected autoimmune disease, or autoimmune paraneoplastic syndrome requiring systemic therapy;\n* Allergy to the test drug;\n* Have or currently have interstitial lung disease;\n* Coexisting with HIV infection or active hepatitis;\n* Patients who have undergone other major surgery or severe trauma within 2 months before the start of the trial;\n* Pregnant or breastfeeding women;\n* Those who suffer from neurological diseases or mental illnesses who cannot cooperate;\n* Other reasons that investigators deem inappropriate for enrollment.","ALL","18 Years","70 Years",{"count":53,"type":54},348,"ESTIMATED","INTERVENTIONAL",[57],"PHASE3","To compare the efficiency between surgery and radiotherapy after SHR-1316 (Adebrelimab)and platinum-containing doublet induction therapy for limited-stage small cell lung cancer",[60],"Limited Stage Small Cell Lung Cancer",[62,63,64,65],"LD-SCLC","surgery","radiotherapy","neoadjuvant chemoimmunotherapy","NOT_YET_RECRUITING","2023-05-15",{"date":69,"type":70},"2023-05-17","ACTUAL",{"date":72,"type":54},"2023-08-01",{"date":74,"type":54},"2030-08-01",{"name":5,"class":6},1]