Low-leucine diet with chemotherapy and immunotherapy for advanced stomach 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

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.

Why it matters

Who can join: the full rules

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 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.