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Phase 2 Leucine-Restricted Diet, Gastric Cancer Study

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Summary

NIH's ClinicalTrials.gov has registered Phase 2 trial NCT07537361 evaluating the safety and efficacy of a leucine-restricted diet combined with neoadjuvant chemotherapy and immunotherapy in gastric cancer patients. The study aims to assess whether dietary leucine restriction is safe, well-tolerated, and capable of promoting immune cell activation within the tumor microenvironment to improve patient outcomes. Estimated study completion date is April 17, 2026.

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What changed

NIH's ClinicalTrials.gov has registered a new Phase 2 clinical trial (NCT07537361) investigating the safety and efficacy of a leucine-restricted diet in combination with neoadjuvant chemotherapy and immunotherapy for gastric cancer patients. The study's conditions include gastric cancer and the dietary intervention, with the primary focus on evaluating patient safety, tolerability, and immune response within the tumor microenvironment.

For affected parties including clinical investigators, oncology research institutions, and pharmaceutical companies involved in immuno-oncology drug development, this trial registration signals ongoing interest in metabolic and dietary approaches as complementary cancer therapies. The trial does not create immediate compliance obligations but may inform future dietary intervention protocols and combination treatment strategies in gastric cancer care.

Archived snapshot

Apr 17, 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.

← ClinicalTrials.gov Studies

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

Phase 2 NCT07537361 Kind: PHASE2 Apr 17, 2026

Abstract

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.

Conditions: Gastric Cancer, Leucine-restricted Diet

Interventions: Leucine-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
NCT07537361

Who this affects

Applies to
Pharmaceutical companies Healthcare providers Clinical investigators
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial registration Cancer treatment research
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Topics
Healthcare Public Health

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