Safety and Efficacy of Leucine-Restricted Diet Combined With Chemotherapy and Immunotherap
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 o
| Condition(s) | Advanced Gastric Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * 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. Exclusion Criteria: * Cognitive or Psychiatric Impairment: Cognitive dysfunction or psychiatric disorders that prevent the patient from understanding the study content or providing infor |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Qilu Hospital of Shandong University |
| Locations | Jinan, Shandong, China |
| Start date | 2026-01-01 |
| NCT ID | NCT07537348 |
| Official listing | https://clinicaltrials.gov/study/NCT07537348 |