Omega-3 supplements with PD-1 therapy for 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
This trial will test whether taking omega-3 fish oil (EPA+DHA) together with PD-1 immunotherapy helps adults with recurrent or metastatic esophageal cancer maintain muscle and have better clinical and patient-reported outcomes than a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07272382 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed recurrent or metastatic esophageal cancer who are starting or are eligible for PD-1 inhibitor therapy, with ECOG 0–2 and adequate organ function, fit the study profile.
Not a fit: Patients with primary PD-1 resistance, active esophageal fistula, uncontrolled autoimmune disease or requiring ongoing systemic immunosuppression, interstitial lung disease, or other uncontrolled comorbidities are excluded and are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding omega-3 could slow muscle wasting, improve treatment tolerance and quality of life, and potentially improve clinical outcomes for patients on PD-1 therapy.
How similar studies have performed: Omega-3 supplements have shown modest benefits for muscle mass and inflammation in some cancer settings, but combining EPA/DHA with PD-1 immunotherapy is relatively novel and not yet proven in large trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.