Omega-3 Fatty Acids With PD-1 Inhibitors in Advanced Esophageal Cancer

NCT07272382 | Recruiting DMC

• 1 other identifier: ESO-Shanghai28
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Change in Skeletal Muscle Index (ΔSMI) From Baseline to 6 Months

  From randomization to Month 6 (±4 weeks)

Study Arms (2)

PD-1 + Omega-3 (EPA/DHA)

EXPERIMENTAL

Dietary Supplement: PD-1 + Omega-3 Fatty Acids (EPA/DHA)

PD-1 + Placebo

PLACEBO COMPARATOR

Dietary Supplement: PD-1 + Placebo (Oral Drops)

Interventions

PD-1 + Placebo (Oral Drops) DIETARY_SUPPLEMENT

Comparator: Matching placebo oral drops × 6 months; with PD-1; blinded; adherence via check-ins/bottle counts.

PD-1 + Placebo

PD-1 + Omega-3 Fatty Acids (EPA/DHA) DIETARY_SUPPLEMENT

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.

PD-1 + Omega-3 (EPA/DHA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Central Study Contacts

kuai le zhao Prof

CONTACT

021-64175590; 30635279@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): June 5, 2027
• Study Completion (Estimated): June 5, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 12 months after primary results publication and for 5 years thereafter.
• Access Criteria: Researchers must submit a methodologically sound proposal, IRB/ethics approval (or exemption), and a signed data use agreement. Proposals will be reviewed by the sponsor/investigator committee.

Locations

CN (1)