Safety and Efficacy of Leucine-Restricted Diet Combined With Neoadjuvant Chemotherapy and Immunotherapy in Gastric Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorQilu Hospital of Shandong University

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Leucine-restricted diet

Treatment groups

108 Participants
are divided into 2 treatment groups