[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635927":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":60,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Second Affiliated Hospital of Zunyi Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group: Chemo-Immunotherapy Induction + Radiotherapy + PD-1 Maintenance","EXPERIMENTAL","Patients receive 3 cycles of PD-1 antibody plus chemotherapy induction therapy, followed by thoracic radiotherapy (50.4Gy in 28 fractions), then PD-1 antibody maintenance therapy (200mg IV q3w, up to 1 year).",[13],"Drug: Paclitaxel plus Cisplatin or Carboplatin (Induction Chemotherapy)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group: Concurrent Chemoradiotherapy + PD-1 Maintenance","ACTIVE_COMPARATOR","Patients receive weekly paclitaxel + cisplatin\u002Fcarboplatin concurrent with thoracic radiotherapy (50.4Gy in 28 fractions), then PD-1 antibody maintenance therapy (200mg IV q3w, up to 1 year).",[19],"Drug: Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Paclitaxel plus Cisplatin or Carboplatin (Induction Chemotherapy)","Paclitaxel 150-175 mg\u002Fm² combined with cisplatin 75 mg\u002Fm² or carboplatin AUC 5 (maximum 600 mg), administered intravenously every 3 weeks for 3 cycles, concurrent with PD-1 antibody induction therapy for unresectable stage III-IVA esophageal squamous cell carcinoma.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Weekly Paclitaxel plus Cisplatin or Carboplatin (Concurrent Chemotherapy)","Paclitaxel 50 mg\u002Fm² combined with cisplatin 25 mg\u002Fm² or carboplatin AUC 5 (maximum 600 mg), administered intravenously once weekly for 5 cycles, concurrent with thoracic radiotherapy (50.4Gy in 28 fractions) for unresectable stage III-IVA esophageal squamous cell carcinoma.",[15],[32],{"name":33,"affiliation":34,"role":35},"Lei Zhou, Master","The Second Affiliated Hospital of Zunyi Medical University","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Jian-Guo Zhou, PhD","CONTACT","+86-851-18212154044","jsdxzl@126.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"The Second Affiliated Hospital of Zunyi Medical University, Xinpu New District, Honghuagang District, Zunyi City, Guizhou Province","RECRUITING","Zunyi","Guizhou","563000","China","CN",{"type":52,"coordinates":53},"Point",[54,55],106.90722,27.68667,{"lat":55,"lon":54},[58],{"name":59,"role":39,"phone":40,"phoneExt":26,"email":41},"lei zhou, Master",{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100635927","phase-2-induction-chemo-immunotherapy--radiotherapy-vs-concurrent-chemoradiotherapy-for-unresectable-locally-advanced-esophageal-squamous-cell-carcinoma-100635927",false,"NCT07559045","Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma","Efficacy and Safety of Induction Chemo-Immunotherapy Followed by Radiotherapy vs Concurrent Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Randomized, Two-Arm, Phase II Study","Inclusion Criteria:\n\n* Histologically or cytologically confirmed unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Adequate organ function (bone marrow, liver, renal, cardiac) within 2 weeks prior to randomization\n* Measurable or evaluable disease per RECIST 1.1\n* Willing to provide written informed consent\n\nExclusion Criteria:\n\n* Previous radiotherapy to the chest or previous systemic chemotherapy for ESCC\n* History of other malignancies within the last 5 years (except cured basal cell carcinoma or cervical carcinoma in situ)\n* Severe comorbidities (uncontrolled hypertension, NYHA class III-IV heart failure, active infection, etc.)\n* Known hypersensitivity to any study drugs (paclitaxel, cisplatin\u002Fcarboplatin, PD-1 antibody)\n* Pregnant or lactating women\n* Participation in another clinical trial within 30 days prior to randomization","ALL","18 Years","75 Years",{"count":73,"type":74},92,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","This is a prospective, randomized, phase II clinical study in patients with unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC). Eligible patients will be randomly assigned in a 1:1 ratio to two treatment groups. The experimental group will receive 3 cycles of induction therapy with PD-1 antibody plus chemotherapy, followed by radiotherapy, and then maintenance therapy with PD-1 antibody monotherapy. The control group will receive concurrent chemoradiotherapy, followed by maintenance therapy with PD-1 antibody monotherapy. The primary endpoints are the complete response (CR) rate at 3 months after radiotherapy (assessed by investigators) and the 1-year progression-free survival (PFS) rate. Secondary endpoints include overall survival (OS), progression-free survival (PFS), duration of response, objective response rate (ORR), local-regional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), quality of life, and safety profile.",[80],"Esophageal Squamous Cell Carcinoma (ESCC)",[82,83,84,85,86],"Esophageal Squamous Cell Carcinoma","Chemo-Immunotherapy","Induction Therapy","Concurrent Chemoradiotherapy","PD-1 Inhibitor","2026-04-26",{"date":89,"type":90},"2026-04-30","ACTUAL",{"date":92,"type":90},"2026-01-01",{"date":94,"type":74},"2028-06-30",{"name":5,"class":6},1]