Actively Recruiting
Safety and Efficacy of Leucine-Restricted Diet Combined With Neoadjuvant Chemotherapy and Immunotherapy in Gastric Cancer
Led by Qilu Hospital of Shandong University · Updated on 2026-04-17
108
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of Leucine-Restricted Diet Combined With Neoadjuvant Chemotherapy and Immunotherapy in Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed locally advanced gastric cancer
- Aged 18 to 70 years, any gender
- Able to eat by mouth or receive liquid diet via nasogastric tube
- Willing to participate and have signed informed consent
- No distant metastasis on imaging with clinical stage requiring neoadjuvant chemo-immunotherapy
- No other primary malignant tumors besides gastric cancer
You will not qualify if you...
- Severe cognitive or psychiatric disorders preventing understanding or consent
- Diagnosis of Type 1 or Type 2 diabetes mellitus
- Severe diarrhea, intractable vomiting, malabsorption syndrome, intestinal obstruction, or active gastrointestinal bleeding
- Known allergy to leucine-deficient nutritional powder components
- Use of other nutritional supplements that may affect study results
- Unable to tolerate neoadjuvant chemo-immunotherapy or severe gastrointestinal side effects
- Postoperative diagnosis of non-primary gastric cancer (e.g., metastatic tumors from other sites)
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
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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