Omega-3 supplements with PD-1 therapy for advanced esophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled phase II trial randomizing adults with recurrent or metastatic esophageal cancer 1:1 to PD-1 inhibitor therapy plus oral omega-3 (EPA 2.5 g + DHA 1.25 g daily) or PD-1 therapy plus matching placebo for six months. The primary physiological question is whether omega-3 increases the change in skeletal muscle index over six months, with secondary evaluations of clinical outcomes, immune and metabolic biomarkers, and patient-reported outcomes. Participants attend baseline, 3-month, and 6-month visits (then every 3 months up to 2 years) for body composition and functional assessments, blood sampling, questionnaires, and adherence monitoring. Key eligibility includes ECOG 0–2 and PD‑1 inhibitor naïve or prior PD‑1 stopped >3 months without primary resistance, while those with PD‑1 resistance, esophageal fistula, active uncontrolled autoimmune disease, ongoing immunosuppression, or interstitial lung disease are excluded.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: kuai le zhao Prof
• Email: 30635279@qq.com
• Phone: 021-64175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.