Low-leucine diet with chemotherapy and immunotherapy for advanced stomach cancer
A Study on the Safety and Efficacy of Leucine-Restricted Diet in Gastric Cancer Patients Treated With Chemotherapy and Immunotherapy
PHASE2 · Qilu Hospital of Shandong University · NCT07537348
This will test whether a low-leucine diet helps people with advanced gastric cancer respond better to combined chemotherapy and immunotherapy.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 73 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT07537348 on ClinicalTrials.gov |
What this trial studies
This single-center, self-controlled Phase 2 study combines a leucine-restricted diet with standard chemotherapy and immunotherapy in patients with advanced gastric cancer. Participants serve as their own controls while investigators monitor serum amino acid levels, tumor immune microenvironment changes, and body composition before and after the dietary intervention. Anti-tumor efficacy will be measured by tumor response rates, pathological tumor regression grade for patients eligible for R0 resection, and survival endpoints including 1-year survival and overall survival. Safety and tolerability of the diet will be tracked alongside routine treatment-related assessments.
Who should consider this trial
Good fit: Adults aged 18–70 with imaging- or pathology-confirmed advanced gastric cancer with distant metastases who are planned for combined chemotherapy and immunotherapy, can take nutrition orally or via nasogastric tube, and can provide informed consent.
Not a fit: Patients with type 1 or type 2 diabetes, severe gastrointestinal malabsorption or uncontrolled vomiting/diarrhea, significant cognitive or psychiatric impairment, or concurrent primary malignancies are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding a leucine-restricted diet could increase tumor response rates and improve 1-year survival and overall survival when given with chemotherapy and immunotherapy.
How similar studies have performed: Preclinical studies and limited human data show leucine restriction can lower serum leucine and enhance tumor immune activation, but using a leucine-restricted diet together with chemoimmunotherapy in advanced gastric cancer is largely unproven in clinical trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis and Treatment Plan: Patients with advanced gastric cancer with distant metastasis, confirmed by imaging modalities (such as CT or PET-CT) and clinical pathological data, who are indicated for combined chemotherapy and immunotherapy. * Demographics: Aged 18 to 70 years, regardless of gender. * Dietary Capability: Capable of oral intake or receiving liquid diet via nasogastric tube. * Consent: Willing to participate in this study and have signed the Informed Consent Form (ICF). * Exclusion of Other Malignancies: No concurrent primary malignant tumors other than gastric cancer. Exclusion Criteria: * Cognitive or Psychiatric Impairment: Cognitive dysfunction or psychiatric disorders that 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：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 efficacy evaluation. * Treatment Tolerance: Inability to tolerate combined chemotherapy and immunotherapy, or occurrence of severe gastrointestinal adverse events following such treatment.
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: Advanced Gastric Cancer, Leucine-Restricted Diet, Chemotherapy, Immunotherapy