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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response (pCR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
experimental group
Receiving Omega-3 supplementation alongside standard neoadjuvant immunotherapy
干预措施: Omega-3 Supplementation (Dietary Supplement)
experimental group
Receiving Omega-3 supplementation alongside standard neoadjuvant immunotherapy
干预措施: Neoadjuvant Immunotherapy (Drug)
control group
Receiving only the standard immunotherapy
干预措施: Neoadjuvant Immunotherapy (Drug)
结局指标
主要结局
Pathologic Complete Response (pCR)
时间窗: 8 to 12 weeks
次要结局
- Major Pathological Response (MPR)(8 to 12 weeks)
研究者
Hao Xu
Professor
The First Affiliated Hospital with Nanjing Medical University