Actively Recruiting
Omega-3 Fatty Acids With PD-1 Inhibitors in Advanced Esophageal Cancer
Led by Fudan University · Updated on 2025-12-09
142
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Omega-3 Fatty Acids With PD-1 Inhibitors in Advanced Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status 0 to 2
- Histologically confirmed recurrent or metastatic esophageal cancer (AJCC 8th edition; de novo stage IV or relapse after prior therapy)
- PD-1 inhibitor naïve, or prior PD-1 stopped more than 3 months ago with subsequent progression (no primary PD-1 resistance)
- Adequate organ function according to protocol (hematologic, hepatic, renal)
- Women of childbearing potential must have a negative pregnancy test and agree to effective contraception
- Signed informed consent
You will not qualify if you...
- PD-1 inhibitor resistance or refractory disease to prior PD-1 therapy
- Present or strongly suspected esophageal fistula
- Active autoimmune disease or immunodeficiency requiring systemic therapy (exceptions per protocol, e.g., treated hypothyroidism, controlled type 1 diabetes)
- Ongoing use of systemic corticosteroids or other immunosuppressants (physiologic or topical steroids allowed)
- History of interstitial lung disease or pneumonitis, or active pneumonitis on screening CT
- Uncontrolled cardiovascular disease (e.g., NYHA class II or higher heart failure, unstable angina, recent myocardial infarction, significant uncontrolled arrhythmias)
- Serious active infection including active tuberculosis; uncontrolled viral hepatitis (active HBV/HCV per protocol)
- Pregnant or breastfeeding
- Recent major surgery within protocol-defined window or high bleeding risk/therapeutic anticoagulation unsuitable for omega-3 use
- Other conditions that, in investigator's judgment, prevent protocol compliance or safety
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
K
kuai le zhao Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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