[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642953":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":42,"locations":31,"responsibleParty":50,"collaborators":31,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":31,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":31,"overallStatus":72,"whyStopped":31,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":31},{"fullName":5,"class":6},"Henan Cancer Hospital","OTHER_GOV",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Organ Preservation with Radical Chemoradiotherapy","EXPERIMENTAL","Patients achieving clinical complete or partial response (cCR\u002FcPR) after neoadjuvant immunochemotherapy will receive definitive chemoradiotherapy for organ preservation. Radiotherapy (50.4 Gy\u002F28 fractions, IMRT) with concurrent weekly chemotherapy (e.g., paclitaxel + cisplatin). Patients with ycCR after chemoradiotherapy will enter observation. Patients with residual disease will undergo salvage esophagectomy.",[13,14],"Drug: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy","Combination Product: Radiation with Concurrent Chemotherapy",{"label":16,"type":10,"description":17,"interventionNames":18},"Immediate Esophagectomy","Patients achieving cCR\u002FcPR after neoadjuvant immunochemotherapy will undergo immediate radical esophagectomy (McKeown or Ivor-Lewis procedure) with 2-field or 3-field lymph node dissection. Postoperative immunotherapy (up to 8 cycles) may be administered based on pathological findings (ypT≥1 or N+).",[13,19],"Procedure: Radical Esophagectomy",{"label":21,"type":22,"description":23,"interventionNames":24},"Non-Responder Surgery","ACTIVE_COMPARATOR","Patients with stable disease (cSD) or progressive disease (cPD) after neoadjuvant immunochemotherapy will undergo immediate radical esophagectomy, which is the standard of care for this subgroup. Postoperative treatment is determined by pathological findings.",[13,19],[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy","This is the standard induction therapy administered to all enrolled patients. It consists of the PD-1 inhibitor Toripalimab combined with Nab-paclitaxel",[16,21,9],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"COMBINATION_PRODUCT","Radiation with Concurrent Chemotherapy","Chemotherapy administered concurrently with radiotherapy",[9],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":31},"PROCEDURE","Radical Esophagectomy","Standard surgical procedure with lymph node dissection",[16,21],[43,48],{"name":44,"role":45,"phone":46,"phoneExt":31,"email":47},"Yan Zheng, M.D.\u002FPh.D","CONTACT","(+86)0371-65587610","hnszlyylixiang@163.com",{"name":49,"role":45,"phone":46,"phoneExt":31,"email":47},"Song",{"type":51,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100642953","phase-3-surgery-vs-radical-chemoradiotherapy-for-esophageal-scc-after-neoadjuvant-immunochemotherapy-100642953",false,"NCT07629817","Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy","A Multicenter, Open-Label, Randomized Controlled Phase III Clinical Trial Comparing Surgery Versus Radical Chemoradiotherapy (Organ Preservation) in Patients With Thoracic Esophageal Squamous Cell Carcinoma Achieving cCR or cPR Following Neoadjuvant Immunochemotherapy","HCHTOG2603","Inclusion Criteria:\n\n\\-\n\nBased on the study protocol, the Inclusion Criteria translated into English are as follows:\n\n1. Age 18-75 years, any sex.\n2. ECOG Performance Status 0-1.\n3. Histologically confirmed, previously untreated thoracic esophageal squamous cell carcinoma (ESCC).\n4. Clinical stage cT2N0M0, T3N0-2M0 (AJCC 8th Edition), assessed as resectable with a potential for R0 resection by endoscopic ultrasound (EUS), PET-CT, and contrast-enhanced CT. Patients with cervical lymph node metastasis may also be included if deemed suitable for three-field lymphadenectomy by a multidisciplinary team assessment.\n5. Adequate bone marrow, hepatic, and renal function:\n\n   * Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL, Platelet count ≥ 100 × 10⁹\u002FL, Hemoglobin ≥ 90 g\u002FL.\n   * Alanine aminotransferase \u002F Aspartate aminotransferase ≤ 2.5 × Upper Limit of Normal, Total bilirubin ≤ 1.5 × Upper Limit of Normal.\n   * Serum creatinine ≤ 1.5 × Upper Limit of Normal or Creatinine clearance ≥ 60 mL\u002Fmin.\n6. Signed written informed consent form (ICF).\n\nExclusion Criteria:\n\n\\-\n\nBased on the study protocol, the Exclusion Criteria you listed translate into English as follows:\n\n1. History of other malignancy within the past 5 years.\n2. Active autoimmune disease.\n3. Active Hepatitis B Virus (HBV) \u002F Hepatitis C Virus (HCV) \u002F Human Immunodeficiency Virus (HIV) infection.\n4. Severe cardiac or pulmonary insufficiency (Left Ventricular Ejection Fraction \\\u003C 50%, Forced Expiratory Volume in 1 second \\\u003C 1 L).\n5. Pregnancy or lactation.","ALL","18 Years","75 Years",{"count":64,"type":65},1044,"ESTIMATED","INTERVENTIONAL",[68],"PHASE3","This is a Phase III, multicenter, open-label, randomized controlled trial. The study aims to compare organ preservation versus esophagectomy in patients with locally advanced, resectable thoracic esophageal squamous cell carcinoma (ESCC) who achieve a complete or partial clinical response (cCR\u002FcPR) following neoadjuvant immunochemotherapy.",[71],"Esophageal Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-06-07",{"date":75,"type":76},"2026-06-10","ACTUAL",{"date":78,"type":65},"2026-06-15",{"date":80,"type":65},"2032-03-15",{"name":5,"class":6}]