Safety and Efficacy of Leucine-Restricted Diet Combined With Chemotherapy and Immunotherapy in Advanced Gastric Cancer
A Study on the Safety and Efficacy of Leucine-Restricted Diet in Gastric Cancer Patients Treated With Chemotherapy and Immunotherapy
Qilu Hospital of Shandong University
73 participants
Jan 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- 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.
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Interventions
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.
Locations(1)
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NCT07537348