Consistent with previous literature, the investigators postulate that a leucine-restricted diet is safe and well-tolerated in gastric cancer patients receiving neoadjuvant chemo-immunotherapy. Furthermore, the investigators propose that this dietary regimen promotes the activation of immune cells within the tumor microenvironment (TME). When combined with neoadjuvant chemo-immunotherapy, it demonstrates synergistic anti-tumor efficacy, thereby improving patient prognosis.
Pathological Confirmation: Histologically confirmed locally advanced gastric cancer.
Demographics: Aged 18 to 70 years, inclusive, regardless of gender.
Dietary Capability: Capable of oral intake or receiving a liquid diet via nasogastric tube.
Consent: Willing to participate in the study and have signed the Written Informed Consent Form (ICF).
Cognitive or Psychiatric Impairment: Cognitive dysfunction or psychiatric disorders severe enough to 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/Hypersensitivity: Known hypersensitivity or allergy to any of the main components of the leucine-deficient nutritional powder.
Parallel
Leucine-restricted diet
Dietary supplementPatients received a total of four cycles of neoadjuvant therapy.During each treatment cycle, patients adhered to a leucine-restricted diet for 3 days. After this 3-day period, the dietary intervention was stopped, and patients gradually resumed a normal diet for the remainder of the cycle.
Response Evaluation Criteria in Solid Tumors (RECIST) Grade
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)
This indicator is calculated by comprehensively summarizing the 1-year survival rate and overall survival.
The tumor regression grade (TRG) system
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
The CTCAE grading system comprises five grades (1-5). Grade 1 represents no or mild symptoms, while Grade 5 indicates death.
Serum amino acid concentrations in patients
Following leucine-restricted diet intervention, peripheral venous blood was collected from gastric cancer patients to measure serum concentrations of various amino acids, including leucine.
Changes in the Immune Microenvironment
Tumor single-cell RNA sequencing (scRNA-seq) and circulating tumor DNA (ctDNA) data were compared before and after the dietary intervention. Additionally, peripheral blood samples were collected for flow cytometric analysis of CD8+ T cells and ctDNA quantification.
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