[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632884":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":38,"centralContacts":43,"locations":48,"responsibleParty":66,"collaborators":27,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":27,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":51,"whyStopped":27,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Sichuan University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Intensive Nutritional Support Group","EXPERIMENTAL","Patients in this group receive intensive oral enteral nutritional support in addition to the standard conversion therapy (PD-1 inhibitor plus chemotherapy).",[13,14,15],"Drug: PD-1 Inhibitor plus Chemotherapy","Dietary Supplement: Oral Enteral Nutritional Preparation","Procedure: Esophagectomy with lymph node dissection",{"label":17,"type":18,"description":19,"interventionNames":20},"Standard Nutritional Support Group","ACTIVE_COMPARATOR","Patients in this group receive routine nutritional guidance\u002Fsupport in addition to the standard conversion therapy (PD-1 inhibitor plus chemotherapy)",[13,15],[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","PD-1 Inhibitor plus Chemotherapy","PD-1 inhibitor combined with chemotherapy (Paclitaxel or Albumin-bound paclitaxel plus Cisplatin or Carboplatin), administered once every 3 weeks for 2 cycles.",[9,17],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"DIETARY_SUPPLEMENT","Oral Enteral Nutritional Preparation","Oral enteral nutritional preparation taken twice daily for 2 cycles (each cycle is 3 weeks).",[9],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":27},"PROCEDURE","Esophagectomy with lymph node dissection","Surgical resection of the esophagus and lymph node dissection, planned 4-6 weeks after the completion of conversion therapy.",[9,17],[39],{"name":40,"affiliation":41,"role":42},"Zhenyu Ding, PhD","West China Hospital","STUDY_CHAIR",[44],{"name":40,"role":45,"phone":46,"phoneExt":27,"email":47},"CONTACT","+86-189-8060-1957","dingzhenyu@scu.edu.cn",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"West China Hospital, Sichuan University","RECRUITING","Chengdu","Sichuan","610041","China","CN",{"type":58,"coordinates":59},"Point",[60,61],104.06667,30.66667,{"lat":61,"lon":60},[64],{"name":65,"role":45,"phone":46,"phoneExt":27,"email":47},"Zhenyu Ding, MD, PhD",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":41,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Zhen-Yu Ding","Professor","100632884","phase-2-intensive-nutritional-support-in-conversion-therapy-for-locally-advanced-unresectable-escc-100632884",false,"NCT07519486","Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable ESCC","A Prospective Randomized Controlled Clinical Trial of Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma","INS-ESCC-CT","Inclusion Criteria:\n\nPathologically confirmed Esophageal Squamous Cell Carcinoma (ESCC). Aged 18-80 years, regardless of gender. ECOG Performance Status (PS) 0-2, and weight loss \\\u003C 10% within the past 6 months.\n\nConfirmed locally advanced unresectable ESCC according to NCCN Guidelines (Version 2026.1).\n\nPlanned to receive surgery after completion of conversion therapy, with no surgical contraindications.\n\nTreatment-naive: No prior anti-tumor therapy for ESCC, including radiotherapy, chemotherapy, or surgery.\n\nPresence of measurable lesion(s) according to RECIST 1.1. Expected survival ≥ 3 months. Able to swallow and tolerate oral medications. Adequate organ function (blood counts, biochemistry, and coagulation parameters meeting protocol requirements).\n\nWomen of childbearing age and men must agree to use effective contraception during the study and for 6 months after completion.\n\nVoluntary participation with signed informed consent and good compliance.\n\nExclusion Criteria:\n\nPresence of esophageal-mediastinal fistula and\u002For tracheoesophageal fistula, or tumor invasion of major vessels with risk of fatal hemorrhage.\n\nHistory of other malignant tumors within the past 5 years. Current or prior use of immunosuppressants or systemic steroids (\\>10 mg\u002Fday prednisone equivalent) within 2 weeks prior to first dose.\n\nActive autoimmune disease or history of autoimmune disease requiring systemic treatment.\n\nKnown immunodeficiency history, including HIV infection, organ transplant, or bone marrow transplant.\n\nUncontrolled concurrent diseases (e.g., uncontrolled hypertension, unstable angina, recent myocardial infarction, or severe infections).\n\nActive tuberculosis (TB) or history of TB without standardized treatment. Active Hepatitis B (HBV) or Hepatitis C (HCV) infection. Complete inability to take oral enteral nutrition due to esophageal stenosis. History or current presence of interstitial pneumonia or interstitial lung disease.\n\nUncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n\nSignificant gastrointestinal disorders with severe diarrhea (CTCAE \\> Grade 2). Pregnant or lactating women. Participation in other clinical trials within 30 days prior to enrollment.","ALL","18 Years","80 Years",{"count":82,"type":83},118,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","Malnutrition is highly prevalent in patients with upper gastrointestinal tumors, which may negatively impact treatment tolerance and anti-tumor immune responses. This study aims to evaluate the efficacy and safety of intensive enteral nutritional support in patients with locally advanced unresectable esophageal squamous cell carcinoma (ESCC) undergoing conversion therapy. Participants receiving PD-1 inhibitors combined with chemotherapy will be randomly assigned to either intensive nutritional support or standard care. The primary goal is to determine if intensive nutritional support can improve the pathological complete response (pCR) rate after subsequent surgery.",[89,90],"Esophageal Squamous Cell Carcinoma","Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma",[92,93,94],"Esophageal Neoplasms","Nutritional Support","Neoadjuvant Therapy","2026-04-10",{"date":97,"type":98},"2026-04-15","ACTUAL",{"date":100,"type":83},"2026-04",{"date":102,"type":83},"2028-03",{"name":5,"class":6},1]