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

NCT07537361 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-04-17

No results posted yet for this study

Summary

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

Interventions

DIETARY_SUPPLEMENT

Leucine-restricted diet

Patients received a total of four cycles of neoadjuvant therapy.During each treatment cycle, patients adhered to a leucine-restricted diet for 3 days. After this 3-day period, the dietary intervention was stopped, and patients gradually resumed a normal diet for the remainder of the cycle.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-06-30
Completion
2027-08-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07537361 on ClinicalTrials.gov