Leucine-restricted diet combined with pre-surgery chemo-immunotherapy for locally advanced gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.