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.
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.
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.
Parallel
Omega-3 Supplementation
Dietary supplementParticipants 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.
Neoadjuvant Immunotherapy
DrugParticipants 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.
Pathologic Complete Response (pCR)
Major Pathological Response (MPR)
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The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
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
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