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Omega-3 Supplementation and Immunotherapy in Gastric Cancer: A Phase II Trial

NCT07050524 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-07-03

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if Omega-3 fatty acids supplementation can enhance the efficacy of neoadjuvant immunotherapy in patients with locally advanced gastric and gastroesophageal junction adenocarcinoma. The main questions it aims to answer are: does Omega-3 supplementation improve the pathologic complete response (pCR) rate compared to standard neoadjuvant immunotherapy alone, and is there an increase in the major pathological response (MPR) rate with Omega-3 supplementation? Researchers will compare the group receiving Omega-3 supplementation with the control group receiving standard neoadjuvant immunotherapy to see if Omega-3 supplementation leads to better treatment outcomes. Participants will receive Omega-3 fatty acids supplements in conjunction with their prescribed neoadjuvant immunotherapy, undergo regular assessments of their pathologic response to treatment, and provide information on their nutritional status and quality of life throughout the study.

Conditions

  • Gastric Cancer Stage III

Interventions

DIETARY_SUPPLEMENT

Omega-3 Supplementation

Participants assigned to the experimental group will receive Omega-3 fatty acids supplementation as part of their treatment regimen. The Omega-3 supplementation will consist of high-quality fish oil capsules, providing a daily dose of \[specific dosage, e.g., 2000 mg of EPA and DHA combined\], taken orally. This supplementation will commence concurrently with the initiation of neoadjuvant immunotherapy and will continue throughout the treatment period.

DRUG

Neoadjuvant Immunotherapy

Participants in both the experimental and control groups will receive neoadjuvant immunotherapy designed to stimulate the body's immune response against locally advanced gastric and gastroesophageal junction adenocarcinomas. The specific regimen will involve administration of \[specific immunotherapeutic agents, e.g., pembrolizumab, nivolumab, etc.\] in accordance with established clinical protocols. The neoadjuvant immunotherapy will be administered through intravenous infusion, typically starting \[specify timeline, e.g., 4-6 weeks\] prior to surgical resection of the tumor. Treatment cycles will be scheduled every \[specify interval, e.g., 2 or 3 weeks\], depending on the specific agent used and participant response.

Sponsors & Collaborators

  • First Affiliated Hospital of Suzhou Medical College

    collaborator OTHER

  • The Affiliated Hospital of Xuzhou Medical University

    collaborator OTHER

  • The Affiliated Jiangning Hospital of Nanjing Medical University

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-09-30
Completion
2027-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07050524 on ClinicalTrials.gov