[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645114":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":46,"locations":52,"responsibleParty":68,"collaborators":28,"id":70,"slug":28,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":28,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":28,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":93,"whyStopped":28,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Tang-Du Hospital","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Low-Dose Radiotherapy + Tislelizumab + Chemotherapy","EXPERIMENTAL","Neoadjuvant low-dose short-course radiotherapy (10 Gy in 5 fractions) followed by tislelizumab combined with nab-paclitaxel and carboplatin for 3 cycles, then surgical resection.",[13,14,15,16],"Drug: Albumin-bound paclitaxel","Radiation: Low-dose Short-course Radiotherapy","Drug: Tislelizumab Combined With Chemotherapy for 3 cycles","Drug: Carboplatin (AUC 5)",{"label":18,"type":10,"description":19,"interventionNames":20},"High-Dose Radiotherapy + Tislelizumab + Chemotherapy","Neoadjuvant high-dose short-course radiotherapy (15 Gy in 5 fractions) followed by tislelizumab combined with nab-paclitaxel and carboplatin for 3 cycles, then surgical resection.",[13,21,15,16],"Radiation: High-dose Short-course Radiotherapy",[23,29,34,38,42],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Albumin-bound paclitaxel","Albumin-bound paclitaxel at a dose of 125 mg\u002Fm² is administrated intravenously on day 1 and day 8 of each 3-week cycle, for a total of 3 cycles.",[18,9],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"RADIATION","Low-dose Short-course Radiotherapy","Neoadjuvant short-course radiotherapy with a total dose of 10 Gy, delivered in 5 daily fractions of 2.0 Gy per fraction, administered consecutively before systemic combination therapy.",[9],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"High-dose Short-course Radiotherapy","Neoadjuvant short-course radiotherapy with a total dose of 15 Gy, delivered in 5 daily fractions of 3.0 Gy per fraction, administered consecutively before systemic combination therapy.",[18],{"type":24,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"Tislelizumab Combined With Chemotherapy for 3 cycles","Anti-PD-1 monoclonal antibody tislelizumab 200 mg is given by intravenous infusion on day 1 of each 3-week cycle, for up to 3 cycles in the neoadjuvant treatment phase.",[18,9],{"type":24,"name":43,"description":44,"armGroupLabels":45,"otherNames":28},"Carboplatin (AUC 5)","Carboplatin is given intravenously on day 1 of each cycle at a targeted AUC of 5, repeated every 3 weeks for 3 cycles as part of neoadjuvant combination regimen.",[18,9],[47],{"name":48,"role":49,"phone":50,"phoneExt":28,"email":51},"Xiaolong Yan, Doctor","CONTACT","029-84717551","18710959981@163.com",[53],{"facility":54,"status":28,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Tangdu Hospital, Fourth Military Medical University","Xi'an","Shaanxi","710038","China","CN",{"type":61,"coordinates":62},"Point",[63,64],108.92861,34.25833,{"lat":64,"lon":63},[67],{"name":48,"role":49,"phone":50,"phoneExt":28,"email":51},{"type":69,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100645114",false,"NCT07678580","Neoadjuvant Short-Course Radiotherapy Plus Tislelizumab and Chemotherapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma","Neoadjuvant Short-Course Radiotherapy Followed by Tislelizumab Combined With Chemotherapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: A Prospective, Multicenter, Exploratory Study","Inclusion Criteria:\n\n* Voluntarily provided written informed consent prior to any study-related procedures\n* Aged 18 to 75 years, male or female\n* Life expectancy of at least 3 months\n* Predicted to achieve R0 surgical resection\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Histologically confirmed, treatment-naive, resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC) meeting the staging criteria: T1 N1-3 M0 or T2-4a N0-3 M0 (T2 ≥3 cm or poorly differentiated). No suspected metastatic cervical lymph nodes (except for upper thoracic esophageal cancer regional lymph nodes) on neck ultrasound or contrast-enhanced CT, and no distant metastasis on imaging\n* Presence of measurable tumor lesions.\n* Adequate organ function defined by laboratory parameters: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; platelet count ≥100×10⁹\u002FL; hemoglobin ≥90 g\u002FL. Total bilirubin ≤1.5×ULN; AST and ALT ≤2.5×ULN. Serum creatinine ≤1.5×ULN or calculated creatinine clearance ≥60 mL\u002Fmin. INR ≤1.5, PT and APTT ≤1.5×ULN\n* Men and women of childbearing potential must use effective contraception during treatment and for 6 months after the last dose of study treatment\n* Good compliance and ability to complete scheduled follow-up.\n\nExclusion Criteria:\n\n* Prior treatment with PD-1\u002FPD-L1 inhibitors or other immunomodulatory agents targeting T-cell receptors (e.g., CTLA-4, OX40)\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage\n* Active or suspected autoimmune disease, including systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, except type 1 diabetes controlled by replacement therapy, hypothyroidism, or skin disorders not requiring systemic therapy\n* History of grade ≥2 interstitial lung disease\n* Systemic corticosteroids (\\>10 mg prednisone daily or equivalent) or other immunosuppressive agents within 14 days before first study treatment\n* Primary or acquired immunodeficiency, organ transplantation, allogeneic hematopoietic stem cell transplantation\n* Live vaccine within 4 weeks before first study treatment\n* Severe uncontrolled cardiovascular or cerebrovascular disease: Uncontrolled hypertension or pulmonary hypertension. Unstable angina, myocardial infarction, coronary artery bypass grafting, or stent implantation within 6 months. NYHA class ≥2 chronic heart failure. Left ventricular ejection fraction (LVEF) \\\u003C50%.\n\nClinically significant arrhythmia requiring treatment. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months. Uncontrolled active infection requiring systemic antibiotics. Positive HIV test, active hepatitis B or hepatitis C infection (exceptions: HBV DNA \\\u003C500 IU\u002FmL; HCV RNA undetectable).\n\nActive pulmonary tuberculosis (TB). Other active malignancy within the previous 2 years, except adequately treated thyroid cancer, carcinoma in situ of the cervix, basal\u002Fsquamous cell skin cancer, or ductal carcinoma in situ of the breast\n\n* History of drug abuse or psychiatric disorder\n* Pregnant or lactating women\n* Any other severe medical, psychiatric, or laboratory abnormality that, in the investigator's opinion, would increase study-related risk or interfere with result interpretation.","ALL","18 Years","75 Years",{"count":80,"type":81},50,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","Neoadjuvant Short-Course Radiotherapy Followed by Tislelizumab Plus Chemotherapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma This is a prospective, randomized, two-arm, parallel-group, multicenter, exploratory Phase II clinical trial. It aims to evaluate the efficacy and safety of neoadjuvant short-course radiotherapy followed by tislelizumab combined with chemotherapy in participants with locally advanced resectable esophageal squamous cell carcinoma (ESCC).\n\nEligible participants will be randomized in a 1:1 ratio to receive either low-dose or high-dose short-course radiotherapy, followed by tislelizumab, nab-paclitaxel, and carboplatin for 3 cycles. Surgery will be performed 4-6 weeks after the last neoadjuvant treatment.\n\nPrimary endpoint: Pathological Complete Response (pCR) rate. Secondary endpoints: Major Pathological Response (MPR) rate, Objective Response Rate (ORR), R0 resection rate, downstaging rate, 3-year Event-Free Survival (EFS), 3-year Overall Survival (OS), safety profile, and quality of life.\n\nApproximately 50 participants will be enrolled. Randomization will be stratified by tumor location, clinical T stage, and clinical N stage using a stratified block design via an EDC\u002FIWRS system.",[87],"Esophageal Squamous Cell Carcinoma (ESCC)",[89,90,91,92],"Esophageal Squamous Cell Carcinoma","Neoadjuvant Therapy","Short-Course Radiotherapy","PD-1 Inhibitor","NOT_YET_RECRUITING","2026-06-28",{"date":96,"type":97},"2026-07-01","ACTUAL",{"date":99,"type":81},"2026-07-10",{"date":101,"type":81},"2029-06-30",{"name":5,"class":6},1]