[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514415":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":41,"centralContacts":45,"locations":50,"responsibleParty":75,"collaborators":31,"id":77,"slug":31,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":31,"enrollmentInfo":86,"targetDuration":31,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":53,"whyStopped":31,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Shanghai Chest Hospital","OTHER",[8,16,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","PD-1 inhibitor + Paclitaxel + Cisplatin\u002FCarboplatin+ Low-dose radiotherapy (LDRT) + Conventionally fractionated radiotherapy (CFRT)",[13,14,15],"Radiation: LDRT+CFRT","Drug: Immunotherapy","Drug: Chemotherapy",{"label":17,"type":18,"description":19,"interventionNames":20},"Arm B","ACTIVE_COMPARATOR","PD-1 inhibitor + Paclitaxel + Cisplatin\u002FCarboplatin",[14,15],{"label":22,"type":10,"description":23,"interventionNames":24},"Safety Run-in Cohort","Single Arm, LDRT + CFRT + Immunochemotherapy",[13,14,15],[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"RADIATION","LDRT+CFRT","LDRT: Primary tumor and all visible metastatic lesions, DT: 2Gy\u002F2fx, d1-2, Q3W × 4 cycles\n\n; CFRT: Primary tumor, DT:40-50Gy\u002F20-25fx, starting from the 5th immunotherapy cycle",[9,22],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DRUG","Immunotherapy","PD-1 inhibitor 200mg, Q3W, until disease progression or unacceptable toxicity or treatment reaches 2 years",[9,17,22],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"Chemotherapy","Paclitaxel+ Cisplatin, Q3W × 4cycles or Paclitaxel+ Carboplatin, Q3W × 4 cycles",[9,17,22],[42],{"name":43,"affiliation":5,"role":44},"Wen Yu, M.D","PRINCIPAL_INVESTIGATOR",[46],{"name":43,"role":47,"phone":48,"phoneExt":31,"email":49},"CONTACT","021-22200000-3203","yuzhiwen0827@163.com",[51,67],{"facility":52,"status":53,"city":54,"state":31,"zip":55,"country":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Shanghai Ruijin Hospital","RECRUITING","Shanghai","200020","China",{"type":58,"coordinates":59},"Point",[60,61],121.45806,31.22222,{"lat":61,"lon":60},[64],{"name":65,"role":47,"phone":66,"phoneExt":31,"email":31},"Sheng-guang Zhao","021-34186000",{"facility":5,"status":53,"city":54,"state":31,"zip":68,"country":56,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"200030",{"type":58,"coordinates":70},[60,61],{"lat":61,"lon":60},[73],{"name":74,"role":47,"phone":48,"phoneExt":31,"email":49},"Wen Yu",{"type":44,"investigatorFullName":74,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Vice Director of Radiation Oncology Department","100514415",false,"NCT05978193","Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma","First-line Anti-PD-1 Therapy Plus Chemotherapy With or Without Radiotherapy in Metastatic Esophageal Squamous Cell Carcinoma: A Phase II Multi-center Trial (SCR-ESCC-01)","SCR-ESCC-01","Inclusion Criteria:\n\n1. Age ≥18;\n2. Metastatic esophageal squamous cell carcinoma (stage IVB, M1) confirmed by pathology;\n3. ECOG performance status: 0-1 point;\n4. No prior anti-tumor treatment;\n5. Adequate hematologic, renal, hepatic, and cardiac functions that meet the requirements for chemotherapy and immunotherapy assessed by investigators.\n\nExclusion Criteria:\n\n1. Non-squamous cell esophageal carcinoma or ESCC mixed with other pathological types of esophageal cancer;\n2. Patients who are potentially curable with surgery as assessed by investigators;\n3. Pleural metastasis or malignant pleural effusion, pericardial effusion;\n4. Any prior anti-tumor therapy for esophageal cancer, i.e., surgery, radiotherapy, chemotherapy, or immunotherapy;\n5. High risk of gastrointestinal bleeding, esophageal fistula, or perforation;\n6. Patients with Patient-Generated Subjective Globe Assessment (PG-SGA) score≥9;\n7. Unstable cardiac diseases or symptoms;\n8. History of interstitial pulmonary disease, non-infectious pneumonitis; pulmonary fibrosis, or other uncontrolled acute pulmonary disease;\n9. Active autoimmune disease or history of autoimmune disease;\n10. Conditions of immunodeficiency or active infection requiring systemic therapy;\n11. Pregnant or breastfeeding;\n12. Patients with synchronous second primary cancer and a history of malignancy within the past 5 years (excluding completely cured cervical carcinoma in situ or basal cell or squamous cell skin carcinoma).","ALL","18 Years",{"count":87,"type":88},100,"ESTIMATED","INTERVENTIONAL",[91],"PHASE2","SCR-ESCC-01 is a multicenter, randomized, phase II study aiming to investigate the benefit of early involvement of low-dose radiotherapy(LDRT) and conventionally fractionated radiotherapy(CFRT) in the first-line anti-PD-1 based treatment of metastatic ESCC. It begins with a safety run-in phase, followed by a randomized controlled comparison against standard immunochemotherapy.",[94,95,96],"Esophageal Squamous Cell Carcinoma","Esophageal Cancer","Metastatic Esophageal Squamous Cell Carcinoma",[34,98,99,100],"low-dose radiotherapy","Esophageal squamous cell carcinoma","Immunoradiotherapy","2026-01-20",{"date":103,"type":104},"2026-01-22","ACTUAL",{"date":106,"type":104},"2023-01-01",{"date":108,"type":88},"2028-01-01",{"name":5,"class":6},2]