Leucine-restricted diet combined with pre-surgery chemo-immunotherapy for locally advanced gastric cancer
A Study on the Safety and Efficacy of Leucine-Restricted Diet in Gastric Cancer Patients Treated With Neoadjuvant Chemotherapy and Immunotherapy
PHASE2 · Qilu Hospital of Shandong University · NCT07537361
This trial will test whether a short leucine-restricted diet given during pre-surgery chemo-immunotherapy helps people with locally advanced gastric cancer by boosting immune activity and tumor response.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University (other) |
| Drugs / interventions | immunotherapy, Sintilimab |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT07537361 on ClinicalTrials.gov |
What this trial studies
Participants are assigned to either an intervention group that follows a 3-day leucine-restricted diet during each of four neoadjuvant treatment cycles or a control group that maintains a normal diet. All participants receive four cycles of oxaliplatin plus S-1 chemotherapy combined with the PD-1 inhibitor sintilimab before surgery. The study tracks safety, tolerability, immune cell activation within the tumor microenvironment, and measures antitumor effects and clinical outcomes. The design tests whether the dietary intervention produces synergistic anti-tumor effects when added to standard neoadjuvant chemo-immunotherapy.
Who should consider this trial
Good fit: Adults aged 18–70 with histologically confirmed locally advanced gastric cancer, no distant metastases, and who are eligible for neoadjuvant chemo-immunotherapy and able to take oral or liquid nutrition.
Not a fit: Patients with distant metastasis, other active primary malignancies, diabetes (type 1 or 2), severe cognitive or psychiatric impairment, or those unable to comply with oral or nasogastric feeding are excluded or unlikely to benefit.
Why it matters
Potential benefit: If successful, the diet could enhance immune activation, increase tumor shrinkage before surgery, and improve long-term prognosis.
How similar studies have performed: Preclinical studies and limited clinical reports suggest amino-acid restriction can boost antitumor immunity, but applying a leucine-restricted diet with neoadjuvant chemo-immunotherapy in gastric cancer is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathological Confirmation: Histologically confirmed locally advanced gastric cancer. * Demographics: Aged 18 to 70 years, inclusive, regardless of gender. * Dietary Capability: Capable of oral intake or receiving a liquid diet via nasogastric tube. * Consent: Willing to participate in the study and have signed the Written Informed Consent Form (ICF). * Staging and Treatment Indication: No evidence of distant metastasis on imaging examinations (such as CT or PET-CT), with a clinical stage of locally advanced gastric cancer, indicating the need for neoadjuvant chemo-immunotherapy prior to surgery. * Exclusion of Other Malignancies: No concurrent primary malignant tumors other than gastric cancer. Exclusion Criteria: * Cognitive or Psychiatric Impairment: Cognitive dysfunction or psychiatric disorders severe enough to prevent the patient from understanding the study content or providing informed consent. * Diabetes Mellitus: Diagnosis of Type 1 or Type 2 diabetes mellitus. * Gastrointestinal Conditions: Presence of severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic or mechanical intestinal obstruction, or active gastrointestinal bleeding. * Allergy/Hypersensitivity: Known hypersensitivity or allergy to any of the main components of the leucine-deficient nutritional powder. * Concomitant Supplements: Current use of other nutritional supplements that may potentially confound the study results or affect the evaluation of efficacy. * Treatment Tolerance: Inability to tolerate neoadjuvant chemo-immunotherapy, or occurrence of severe gastrointestinal adverse events following such treatment. * Pathological Diagnosis: Postoperative pathological diagnosis confirming non-primary gastric cancer (e.g., metastatic tumors from other origins).
Where this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (RECRUITING)
Study contacts
- Study coordinator: Hui Qu, Doctor of Medicine
- Email: doctorquhui@email.sdu.edu.cn
- Phone: +86-18560085120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastric Cancer, Leucine-restricted Diet, gastric cancer, leucine-restricted diet, Neoadjuvant Therapy, immunotherapy