Omega-3 Fatty Acids With PD-1 Inhibitors in Advanced Esophageal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PD-1 + Omega-3 Fatty Acids (EPA/DHA), PD-1 + Placebo (Oral Drops).
- Who it may be relevant to
- Registry conditions: Esophageal Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Omega-3 Fatty Acids on PD-1 Inhibitor Therapy in Advanced Esophageal Cancer (ESO-Shanghai28): A Phase II Randomized Controlled Trial
Overview
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.
Interventions
- Dietary supplement PD-1 + Omega-3 Fatty Acids (EPA/DHA)
Intervention: Omega-3 (EPA 2.5 g + DHA 1.25 g/day) oral drops × 6 months; with PD-1; blinded; adherence via check-ins/bottle counts/plasma EPA/DHA. - Dietary supplement PD-1 + Placebo (Oral Drops)
Comparator: Matching placebo oral drops × 6 months; with PD-1; blinded; adherence via check-ins/bottle counts.
Primary outcome measures
- Change in Skeletal Muscle Index (ΔSMI) From Baseline to 6 Months [Time frame: From randomization to Month 6 (±4 weeks)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT07272382 · ESO-Shanghai28