NCT07272382Recruiting
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 · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 142 (estimated)
- First submitted
- 27 Nov 2025
- Start date
- 5 Jun 2025
- Primary completion date
- 5 Jun 2027
- Lead sponsor
- Fudan University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07272382
What you commit to
- Study type: Interventional
- Planned participants: 142
- From 5 Jun 2025 to the primary completion date, 5 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Systemic corticosteroids or other immunosuppressants requiring ongoing use (physiologic or topical steroids allowed).
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.