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Phase 2 Leucine Diet Trial Combined With Chemoimmunotherapy for Advanced Gastric Cancer

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Summary

NIH ClinicalTrials.gov registered a Phase 2 study (NCT07537348) evaluating a leucine-restricted diet combined with chemotherapy and immunotherapy in patients with advanced gastric cancer. The trial will assess safety, tolerability, tumor response rates, and 1-year survival outcomes. No compliance obligations or regulatory actions are imposed by this registry entry.

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What changed

NIH ClinicalTrials.gov published registration details for a Phase 2 clinical trial studying leucine-restricted diet in combination with standard chemotherapy and immunotherapy for advanced gastric cancer patients. The trial targets adults and will evaluate safety, tumor response rates, and 1-year survival outcomes. This is a registry entry documenting an active clinical investigation.

Healthcare providers and clinical investigators may encounter this trial as a potential referral or collaborative research opportunity. Patients with advanced gastric cancer may seek enrollment information. No regulatory compliance obligations or reporting requirements arise from this ClinicalTrials.gov registration.

Archived snapshot

Apr 18, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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Safety and Efficacy of Leucine-Restricted Diet Combined With Chemotherapy and Immunotherapy in Advanced Gastric Cancer

Phase 2 NCT07537348 Kind: PHASE2 Apr 17, 2026

Abstract

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.

Conditions: Advanced Gastric Cancer

Interventions: Lucine-restricted diet

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Last updated

Classification

Agency
NIH
Published
April 17th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07537348

Who this affects

Applies to
Healthcare providers Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Cancer treatment research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Public Health Pharmaceuticals

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