[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562295":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":45,"locations":51,"responsibleParty":67,"collaborators":31,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":31,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":53,"whyStopped":31,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Fujian Medical University Union Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"High PD-L1 Expression Group (CPS ≥ 20)","EXPERIMENTAL","Patients with high PD-L1 expression (CPS ≥ 20) will receive neoadjuvant immunotherapy alone. This treatment consists of serplulimab for 2 cycles.",[13],"Drug: Serplulimab",{"label":15,"type":10,"description":16,"interventionNames":17},"Moderate PD-L1 Expression Group (CPS 10-20)","Patients with moderate PD-L1 expression (CPS 10-20) will receive neoadjuvant chemotherapy combined with immunotherapy. This includes paclitaxel and cisplatin along with serplulimab for 2 cycles.",[13,18],"Drug: Paclitaxel+Cisplatin (Neoadjuvant Chemotherapy)",{"label":20,"type":10,"description":21,"interventionNames":22},"Low PD-L1 Expression Group (CPS \u003C 10)","Patients with low PD-L1 expression (CPS \\\u003C 10) will receive standard neoadjuvant chemoradiotherapy. This includes paclitaxel and cisplatin along with radiotherapy (40 Gy in 20 fractions over 4 weeks).",[23,24],"Drug: Paclitaxel+Cisplatin(Concurrent Chemoradiotherapy)","Radiation: Radiotherapy",[26,32,36,40],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Serplulimab","Serplulimab (300 mg) administered intravenously on day 1 of each 21-day cycle for 2 cycles.",[9,15],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Paclitaxel+Cisplatin (Neoadjuvant Chemotherapy)","Paclitaxel (175 mg\u002Fm²) and Cisplatin (75 mg\u002Fm²) administered intravenously on day 1 of each 21-day cycle for 2 cycles as part of neoadjuvant chemotherapy.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Paclitaxel+Cisplatin(Concurrent Chemoradiotherapy)","Paclitaxel (50 mg\u002Fm²) and Cisplatin (25 mg\u002Fm²) administered intravenously on days 1, 8, 15, and 22 of a 4-week cycle as part of concurrent chemoradiotherapy.",[20],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":31},"RADIATION","Radiotherapy","Radiotherapy at a dose of 40 Gy, delivered in 20 fractions over 4 weeks.",[20],[46],{"name":47,"role":48,"phone":49,"phoneExt":31,"email":50},"Zhao-han Lin","CONTACT","0086-0591-86218329","xhyyllwyh@163.com",[52],{"facility":5,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Fuzhou","Fujian","350001","China","CN",{"type":60,"coordinates":61},"Point",[62,63],119.30611,26.06139,{"lat":63,"lon":62},[66],{"name":47,"role":48,"phone":49,"phoneExt":31,"email":50},{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Yong Yang","Principal Investigator","100562295","phase-2-biomarker-based-neoadjuvant-strategies-for-locally-advanced-resectable-escc-100562295",false,"NCT06601309","Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC","Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: an Exploratory Phase II Single-arm Clinical Study","ESCC","Inclusion Criteria:\n\n1. Diagnosis: Histologically confirmed esophageal squamous cell carcinoma (ESCC).\n2. Stage: Resectable locally advanced ESCC (clinical stage II-III according to the AJCC\u002FUICC 8th edition).\n3. Age: 18-75 years old.\n4. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n5. PD-L1 Expression: Available PD-L1 expression level (CPS).\n6. Surgical Eligibility: Assessed as eligible for surgical resection by a thoracic surgeon.\n7. Laboratory Requirements:\n\n   * Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL, Platelets ≥ 100 x 10\\^9\u002FL, Hemoglobin ≥ 9 g\u002FdL.\n   * Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN.\n   * Adequate renal function: Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL\u002Fmin.\n8. Informed Consent: Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Distant Metastasis: Presence of distant metastasis.\n2. Other Malignancies: History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin carcinoma, or other localized non-invasive malignancy.\n3. Autoimmune Diseases: History of active autoimmune diseases requiring systemic treatment within the past 2 years.\n4. Infections: Active infection requiring systemic therapy.\n5. Uncontrolled Conditions: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n6. Previous Treatment: Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.\n7. Pregnancy and Lactation: Pregnant or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization.\n8. Allergies: Known allergy or hypersensitivity to study drugs or any excipient of these medications.","ALL","18 Years","75 Years",{"count":83,"type":84},90,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","This study aims to evaluate the impact of the neoadjuvant treatment strategy based on CPS score on the pathological complete response (pCR) rate in patients with resectable locally advanced esophageal cancer.",[90],"Esophageal Squamous Cell Carcinoma",[92,93,94,95,96,97],"Esophageal Cancer","Neoadjuvant Therapy","Pathological Complete Response (pCR)","Immunotherapy","Chemoradiotherapy","Biomarkers","2025-09-08",{"date":100,"type":101},"2025-09-15","ACTUAL",{"date":103,"type":101},"2024-07-11",{"date":105,"type":84},"2026-12-01",{"name":5,"class":6},1]