Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. The main questions are: Compared 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 ? Participants will be randomized 1:1 to: Intervention: Standard PD-1 therapy plus oral omega-3 (EPA 2.5 g + DHA 1.25 g per day) for 6 months. Control: 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 + Omega-3 Fatty Acids (EPA/DHA) | Dietary Supplement | — | UNRESOLVED |
| PD-1 + Placebo (Oral Drops) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PD-1 + Omega-3 (EPA/DHA)
- interventionNames
- Dietary Supplement: PD-1 + Omega-3 Fatty Acids (EPA/DHA)
- type
- PLACEBO_COMPARATOR
- label
- PD-1 + Placebo
- interventionNames
- Dietary Supplement: PD-1 + Placebo (Oral Drops)
Primary outcomes (1)
- measure
- Change in Skeletal Muscle Index (ΔSMI) From Baseline to 6 Months
- timeFrame
- From randomization to Month 6 (±4 weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria： Age ≥18 years; ECOG 0-2. Histologically confirmed recurrent/metastatic esophageal cancer (AJCC 8th; de novo stage IV or relapse after prior therapy). PD-1 inhibitor naïve, or prior PD-1 stopped \>3 months with subsequent progression (not primary PD-1 resistance). Adequate organ function per protocol (hematologic, hepatic, renal). Women of childbearing potential: negative pregnancy test and agree to effective contraception. Signed informed consent. Exclusion 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). Systemic corticosteroids or other immunosuppressants requiring ongoing use (physiologic or topical steroids allowed). Interstitial lung disease/pneumonitis history or active pneumonitis on screening CT. Uncontrolled cardiovascular disease (e.g., NYHA ≥ II heart failure, unstable angina, recent MI, significant uncontrolled arrhythmias). Serious active infection, including active TB; uncontrolled viral hepatitis (active HBV/HCV per protocol). Pregnant or breastfeeding. Recent major surgery (per protocol window) or high bleeding risk/therapeutic anticoagulation not suitable for omega-3 use. Other conditions that, in investigator's judgment, preclude protocol compliance or safety.
References
Publications (0)
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