A Study on the Safety and Efficacy of Leucine-Restricted Diet in Gastric Cancer Patients Treated With Chemotherapy and Immunotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Response Evaluation Criteria in Solid Tumors (RECIST) Grade
研究概览
简要总结
Based on existing literature, we posit that a leucine-restricted diet is safe and well-tolerated in patients with advanced gastric cancer receiving combined chemotherapy and immunotherapy. Patients adhering to this dietary regimen exhibit a significant reduction in serum leucine concentrations, with no notable impact on the serum levels of other amino acids. Furthermore, leucine restriction promotes the activation of immune cells within the tumor microenvironment. When applied in conjunction with chemotherapy and immunotherapy for advanced gastric cancer, this approach demonstrates synergistic anti-tumor efficacy. It is expected to enhance tumor response rates , improve the 1-year survival rate, prolong overall survival (OS), and ultimately optimize patient prognosis.
详细描述
This study employs a self-controlled design to comprehensively evaluate the safety and efficacy of a leucine-restricted diet combined with chemotherapy and immunotherapy in patients with advanced gastric cancer, with follow-up assessments of survival status to determine the 1-year survival rate and Overall Survival (OS). For patients eligible for R0 resection, anti-tumor efficacy will be pathologically assessed using the Tumor Regression Grade system, alongside statistical analysis of tumor response rates following combined therapy. Furthermore, the study will investigate mechanistic changes by comparing the tumor immune microenvironment and serum amino acid profiles (including leucine) before and after dietary intervention, while monitoring alterations in patient body composition, ultimately aiming to validate the hypothesis that leucine restriction enhances therapeutic outcomes in this setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis and Treatment Plan: Patients with advanced gastric cancer with distant metastasis, confirmed by imaging modalities (such as CT or PET-CT) and clinical pathological data, who are indicated for combined chemotherapy and immunotherapy.
- •Demographics: Aged 18 to 70 years, regardless of gender.
- •Dietary Capability: Capable of oral intake or receiving liquid diet via nasogastric tube.
- •Consent: Willing to participate in this study and have signed the Informed Consent Form (ICF).
- •Exclusion of Other Malignancies: No concurrent primary malignant tumors other than gastric cancer.
排除标准
- •Cognitive or Psychiatric Impairment: Cognitive dysfunction or psychiatric disorders that prevent the patient from understanding the study content or providing informed consent.
- •Diabetes Mellitus: Diagnosis of Type 1 or Type 2 diabetes mellitus.
- •Gastrointestinal Conditions: Presence of severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic or mechanical intestinal obstruction, or active gastrointestinal bleeding.
- •Allergy：Known hypersensitivity or allergy to any of the main components of the leucine-deficient nutritional powder.
- •Concomitant Supplements: Current use of other nutritional supplements that may potentially confound the study results or affect efficacy evaluation.
- •Treatment Tolerance: Inability to tolerate combined chemotherapy and immunotherapy, or occurrence of severe gastrointestinal adverse events following such treatment.
研究组 & 干预措施
Leucine-restricted diet group
During each hospitalization cycle for combined chemotherapy and immunotherapy, study participants will undergo a 3-day leucine-restricted diet concurrently with PD-1 inhibitor and chemotherapy administration; following this 3-day intervention period, the dietary restriction will be discontinued, and patients will gradually resume a normal diet.
干预措施: Lucine-restricted diet (Dietary Supplement)
结局指标
主要结局
Response Evaluation Criteria in Solid Tumors (RECIST) Grade
时间窗: 1 year after therapy
This scoring system includes four grades: CR, PR, PD, and SD, where CR stands for complete response, PR for partial response, PD for progressive disease, and SD for stable disease.
1-year survival rate and overall survival (OS)
时间窗: 1 year after surgery
This indicator is calculated by comprehensively summarizing the 1-year survival rate and overall survival.
The tumor regression grade (TRG) system
时间窗: 1 month after surgery
TRG (Tumor Regression Grade) is used to assess pathological response after neoadjuvant therapy based on the 8th edition AJCC/CAP criteria. Different grades represent varying degrees of regression: TRG 0 indicates complete response (no residual tumor cells); TRG 1 indicates near-complete response (scattered residual tumor cells, \<10%); TRG 2 indicates partial response (residual tumor cells accounting for 10%-50%); TRG 3 indicates no or minimal response (residual tumor cells \>50%). Higher grades suggest poorer treatment efficacy.
Grade of CTCAE grading system
时间窗: 6 months after therapy
This indicator was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) grading system, which comprises five grades (1-5). Grade 1 represents no or mild symptoms, while Grade 5 indicates death.
次要结局
- Changes in the Immune Microenvironment of Gastric Cancer Patients Following a Leucine-Restricted Diet(Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation.)
- Serum concentrations of various amino acids, including leucine, in patients with gastric cancer(Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation.)