NCT07537361RecruitingPhase 2
Safety and Efficacy of Leucine-Restricted Diet Combined With Neoadjuvant Chemotherapy and Immunotherapy in Gastric Cancer
A Study on the Safety and Efficacy of Leucine-Restricted Diet in Gastric Cancer Patients Treated With Neoadjuvant Chemotherapy and Immunotherapy
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 17 Mar 2026
- Start date
- 1 Jan 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07537361
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 108
- From 1 Jan 2026 to the primary completion date, 30 Jun 2027
- 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 the evaluation of efficacy.
- Treatment Tolerance: Inability to tolerate neoadjuvant chemo-immunotherapy, or occurrence of severe gastrointestinal adverse events following such treatment.
Other illness
- 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.
- Pathological Diagnosis: Postoperative pathological diagnosis confirming non-primary gastric cancer (e.g., metastatic tumors from other origins).
Who the study is looking for
- 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.
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.