NCT07537348RecruitingPhase 2
Safety and Efficacy of Leucine-Restricted Diet Combined With Chemotherapy and Immunotherapy in Advanced Gastric Cancer
A Study on the Safety and Efficacy of Leucine-Restricted Diet in Gastric Cancer Patients Treated With Chemotherapy and Immunotherapy
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 73 (estimated)
- First submitted
- 17 Mar 2026
- Start date
- 1 Jan 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07537348
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 73
- From 1 Jan 2026 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.