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

NCT07050524 | Not Yet Recruiting Phase 2

• 1 other identifier: OSIRIS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

omega-3; Neoadjuvant Immunotherapy; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response (pCR)

  8 to 12 weeks

Secondary Outcomes (1)

• Major Pathological Response (MPR)

  8 to 12 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

Receiving Omega-3 supplementation alongside standard neoadjuvant immunotherapy

Dietary Supplement: Omega-3 Supplementation; Drug: Neoadjuvant Immunotherapy

control group

ACTIVE COMPARATOR

Receiving only the standard immunotherapy

Drug: Neoadjuvant Immunotherapy

Interventions

Omega-3 Supplementation DIETARY_SUPPLEMENT

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.

experimental group

Neoadjuvant Immunotherapy DRUG

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.

control group; experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Participants must be aged 18 years or older.
• Diagnosis: Confirmed diagnosis of locally advanced gastric or gastroesophageal junction adenocarcinoma, classified as clinical stage II or III according to the American Joint Committee on Cancer (AJCC) staging system.
• Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, indicating that patients are fully active or restricted in physically strenuous activity but are capable of self-care.
• Histological Verification: Tissue confirmation of diagnosis must be obtained via biopsy, with adequate archival tumor tissue available for biomarker analysis if required.
• Organ Function: Adequate organ function as evidenced by laboratory tests:
• Absolute neutrophil count (ANC) ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 9 g/dL Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) Total bilirubin ≤ 1.5 times the ULN (unless due to Gilbert's syndrome) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the ULN (≤ 5 times the ULN if liver metastases are present)
• Informed Consent: Ability and willingness to provide written informed consent prior to any study-related procedures.

You may not qualify if:

• Previous Therapy: Prior treatment with chemotherapy, radiation therapy, or immunotherapy for the current cancer diagnosis.
• Concurrent Malignancies: Presence of another active malignancy within the past 5 years (except for non-melanoma skin cancer or cervical carcinoma in situ).
• Active Infection: Presence of any uncontrolled infection requiring systemic therapy or serious co-morbid conditions that would compromise program compliance or interfere with study results.
• Allergies: Known hypersensitivity or contraindications to Omega-3 fatty acid supplementation or components of the immunotherapy regimen.
• Pregnancy/Breastfeeding: Women who are pregnant or breastfeeding; fertile men and women not employing effective contraception during the study period.
• Psychiatric Condition: Any psychiatric condition or substance abuse that would interfere with compliance or affect the participant's safety.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• First Affiliated Hospital of Suzhou Medical College: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• The Affiliated Jiangning Hospital of Nanjing Medical University: collaborator

Study Sites (1)

First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Hao Xu

CONTACT

86-02568306505; zhangyg0021@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This interventional study employs a randomized, controlled design to evaluate the effects of Omega-3 fatty acids supplementation on the efficacy of neoadjuvant immunotherapy in patients with locally advanced gastric and gastroesophageal junction adenocarcinoma. Participants will be randomly assigned to one of two groups: the experimental group receiving Omega-3 supplementation alongside standard neoadjuvant immunotherapy, and the control group receiving only the standard immunotherapy. The primary endpoints include pathologic complete response (pCR) rates and major pathological response (MPR) rates. The study will also assess secondary outcomes such as nutritional status, immune function, inflammatory responses, adverse events, and quality of life metrics. By utilizing a controlled framework, this study aims to provide robust evidence regarding the potential benefits of Omega-3 supplementation in enhancing immunotherapy outcomes for gastrointestinal cancers.

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 3, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

CN (1)