NCT07537348

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Advanced Gastric Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lucine-restricted diet	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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-06-30
• Completion: 2028-12-31
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: China