[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613883":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":50,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":11,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PD-1 + Omega-3 (EPA\u002FDHA)","EXPERIMENTAL",null,[13],"Dietary Supplement: PD-1 + Omega-3 Fatty Acids (EPA\u002FDHA)",{"label":15,"type":16,"description":11,"interventionNames":17},"PD-1 + Placebo","PLACEBO_COMPARATOR",[18],"Dietary Supplement: PD-1 + Placebo (Oral Drops)",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DIETARY_SUPPLEMENT","PD-1 + Omega-3 Fatty Acids (EPA\u002FDHA)","Intervention: Omega-3 (EPA 2.5 g + DHA 1.25 g\u002Fday) oral drops × 6 months; with PD-1; blinded; adherence via check-ins\u002Fbottle counts\u002Fplasma EPA\u002FDHA.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"PD-1 + Placebo (Oral Drops)","Comparator: Matching placebo oral drops × 6 months; with PD-1; blinded; adherence via check-ins\u002Fbottle counts.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"kuai le zhao Prof","CONTACT","021-64175590","30635279@qq.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":11},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":45,"coordinates":46},"Point",[47,48],121.45806,31.22222,{"lat":48,"lon":47},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Kuai Le Zhao, MD","MD","100613883","omega-3-fatty-acids-with-pd-1-inhibitors-in-advanced-esophageal-cancer-100613883",false,"NCT07272382","Omega-3 Fatty Acids With PD-1 Inhibitors in Advanced Esophageal Cancer","Effect of Omega-3 Fatty Acids on PD-1 Inhibitor Therapy in Advanced Esophageal Cancer (ESO-Shanghai28): A Phase II Randomized Controlled Trial","ESO-Shanghai28","Inclusion Criteria： Age ≥18 years; ECOG 0-2. Histologically confirmed recurrent\u002Fmetastatic esophageal cancer (AJCC 8th; de novo stage IV or relapse after prior therapy).\n\nPD-1 inhibitor naïve, or prior PD-1 stopped \\>3 months with subsequent progression (not primary PD-1 resistance).\n\nAdequate organ function per protocol (hematologic, hepatic, renal). Women of childbearing potential: negative pregnancy test and agree to effective contraception.\n\nSigned informed consent.\n\nExclusion Criteria： PD-1 inhibitor resistance or refractory disease to prior PD-1. Esophageal fistula present or strongly suspected. Active autoimmune disease or immunodeficiency requiring systemic therapy (protocol-defined exceptions allowed, e.g., treated hypothyroidism; controlled type 1 diabetes).\n\nSystemic corticosteroids or other immunosuppressants requiring ongoing use (physiologic or topical steroids allowed).\n\nInterstitial lung disease\u002Fpneumonitis history or active pneumonitis on screening CT.\n\nUncontrolled cardiovascular disease (e.g., NYHA ≥ II heart failure, unstable angina, recent MI, significant uncontrolled arrhythmias).\n\nSerious active infection, including active TB; uncontrolled viral hepatitis (active HBV\u002FHCV per protocol).\n\nPregnant or breastfeeding. Recent major surgery (per protocol window) or high bleeding risk\u002Ftherapeutic anticoagulation not suitable for omega-3 use.\n\nOther conditions that, in investigator's judgment, preclude protocol compliance or safety.","ALL","18 Years",{"count":65,"type":66},142,"ESTIMATED","INTERVENTIONAL",[69],"NA","This is a randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate whether adding omega-3 fatty acids improves outcomes in adult patients with recurrent or metastatic esophageal cancer receiving PD-1 inhibitor therapy.\n\nThe main questions are:\n\nCompared with placebo, does omega-3 (EPA+DHA) increase the longitudinal change in skeletal muscle index (ΔSMI) over 6 months? Does it improve clinical outcomes and favorably modulate immune and metabolic biomarkers as well as patient-reported outcomes ?\n\nParticipants will be randomized 1:1 to:\n\nIntervention: Standard PD-1 therapy plus oral omega-3 (EPA 2.5 g + DHA 1.25 g per day) for 6 months.\n\nControl: Standard PD-1 therapy plus matching placebo for 6 months. Participants will attend study visits at baseline, 3 months, and 6 months (then every 3 months up to 2 years), undergo body composition and functional assessments, blood sampling, and questionnaires, and have treatment adherence assessed per protocol. Pre-specified exploratory biomarker analyses will be conducted to support mechanism research.",[72],"Esophageal Neoplasms","2025-12-08",{"date":75,"type":76},"2025-12-09","ACTUAL",{"date":78,"type":76},"2025-06-05",{"date":80,"type":66},"2027-06-05",{"name":5,"class":6},1]