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

Официальное название

Evaluating the Effect of Omega-3 Fatty Acids Supplementation on the Efficacy of Neoadjuvant Immunotherapy in Patients With Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma: A Multicenter, Randomized, Controlled Phase II Clinical Trial

Обзор

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.

Вмешательства

• Пищевая добавка 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.
• Препарат 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 star

Первичные конечные точки

• Pathologic Complete Response (pCR) [Срок оценки: 8 to 12 weeks]

Вторичные конечные точки (1)

• Major Pathological Response (MPR) [Срок оценки: 8 to 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• First Affiliated Hospital with Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT07050524 · OSIRIS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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