A Phase 2 interventional study of Omega-3 Supplementation and Neoadjuvant Immunotherapy in Gastric Cancer Stage III, sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 2, Interventional, and Treatment
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 80 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
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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)
Exclusion Criteria:
Psychiatric Condition: Any psychiatric condition or substance abuse that would interfere with compliance or affect the participant's safety.
Receiving Omega-3 supplementation alongside standard neoadjuvant immunotherapy
Dietary Supplement: Omega-3 Supplementation · Drug: Neoadjuvant Immunotherapy
Receiving only the standard immunotherapy
Drug: Neoadjuvant Immunotherapy
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.
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.
Pathologic Complete Response (pCR)
Time frame: 8 to 12 weeks
Major Pathological Response (MPR)
Time frame: 8 to 12 weeks
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University