Actively Recruiting
Safety and Efficacy of Leucine-Restricted Diet Combined With Chemotherapy and Immunotherapy in Advanced Gastric Cancer
Led by Qilu Hospital of Shandong University · Updated on 2026-04-17
73
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of Leucine-Restricted Diet Combined With Chemotherapy and Immunotherapy in Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with advanced gastric cancer with distant metastasis confirmed by imaging and clinical pathological data
- Indicated for combined chemotherapy and immunotherapy
- Aged 18 to 70 years, any gender
- Able to take oral or liquid diet via nasogastric tube
- Willing to participate and signed informed consent
- No other primary malignant tumors besides gastric cancer
You will not qualify if you...
- Cognitive dysfunction or psychiatric disorders preventing understanding of the study or consent
- Diagnosis of Type 1 or Type 2 diabetes mellitus
- Severe diarrhea, intractable vomiting, severe malabsorption syndrome, intestinal obstruction, or active gastrointestinal bleeding
- Known allergy to components of leucine-deficient nutritional powder
- Currently using other nutritional supplements that may affect study results
- Unable to tolerate combined chemotherapy and immunotherapy or severe gastrointestinal side effects from such treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
H
Hui Qu, Doctor of Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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