Gastric Cancer, Leucine-restricted Diet
Conditions
Keywords
gastric cancer, leucine-restricted diet, Neoadjuvant Therapy, immunotherapy
Brief summary
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.
Detailed description
In this study, participants were divided into an intervention group and a control group. Both groups received four cycles of neoadjuvant therapy comprising Oxaliplatin, S-1, and the PD-1 inhibitor Sintilimab. The intervention group implemented a 3-day leucine-restricted diet during each cycle, gradually resuming a normal diet thereafter, whereas the control group maintained a standard normal diet throughout the treatment period. This design was established to evaluate the safety and efficacy of the leucine-restricted diet in the context of neoadjuvant chemo-immunotherapy for gastric cancer.
Interventions
DIETARY_SUPPLEMENTLeucine-restricted diet
Patients 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.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
In this study, participants were divided into an intervention group and a control group. Both groups received four cycles of neoadjuvant therapy comprising Oxaliplatin, S-1, and the PD-1 inhibitor Sintilimab. The intervention group implemented a 3-day leucine-restricted diet during each cycle, gradually resuming a normal diet thereafter, whereas the control group maintained a standard normal diet throughout the treatment period. This design was established to evaluate the safety and efficacy of the leucine-restricted diet in the context of neoadjuvant chemo-immunotherapy for gastric cancer.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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). * Staging and Treatment Indication: No evidence of distant metastasis on imaging examinations (such as CT or PET-CT), with a clinical stage of locally advanced gastric cancer, indicating the need for neoadjuvant chemo-immunotherapy prior to surgery. * Exclusion of Other Malignancies: No concurrent primary malignant tumors other than gastric cancer.
Exclusion criteria
* 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. * Concomitant Supplements: Current use of other nutritional supplements that may potentially confound the study results or affect the evaluation of efficacy. * Treatment Tolerance: Inability to tolerate neoadjuvant chemo-immunotherapy, or occurrence of severe gastrointestinal adverse events following such treatment. * Pathological Diagnosis: Postoperative pathological diagnosis confirming non-primary gastric cancer (e.g., metastatic tumors from other origins).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Evaluation Criteria in Solid Tumors (RECIST) Grade | 1 year after surgery | 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) | 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 | 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 | 6 months after surgery | The CTCAE grading system comprises five grades (1-5). Grade 1 represents no or mild symptoms, while Grade 5 indicates death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum amino acid concentrations in patients | Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation. | 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 | Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation | 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. |
Countries
China
Contacts
CONTACTHui Qu, Doctor of Medicine
Outcome results
None listed