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

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

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Lucine-restricted diet

Treatment groups

73 Participants
are divided into 1 treatment group