Comprehensive Plasma Metabolomic and Lipidomic Profiling for Predictive Modeling and Biomarker Discovery of Immune-Related Adverse Events in PD-1/PD-L1 Inhibitor-Treated Gastric Cancer Patients: A Prospective Cohort Study

What this Trial Is About

Researchers are investigating metabolic and lipidomic changes in patients with gastric cancer who are starting treatment with PD-1/PD-L1 inhibitors. This observational study aims to identify metabolic and lipid biomarkers linked to immune-related adverse events (irAEs) and to develop models that predict the risk of these events. The goal is to improve personalized treatment approaches and clinical decisions in immunotherapy for gastric cancer. Patients with gastric cancer who have not yet received PD-1/PD-L1 inhibitors are enrolled and plasma samples are collected before starting immunotherapy. For patients who develop irAEs, plasma samples are taken at the onset of these events. For those without irAEs, samples are collected based on treatment cycles matched to those with irAEs. Comprehensive analyses of metabolites and lipids in plasma samples are performed to detect differences related to irAEs and to build predictive risk models. Participants undergo regular plasma sampling and clinical monitoring over the course of one year to assess immune-related adverse events and molecular changes. Quality-of-life data and adverse event severity are also tracked. The study evaluates the associations between metabolic profiles and long-term patient outcomes, with follow-up and data collection continuing up to two years to support prognostic evaluations and clinical decision-making.

Metabolomic and Lipidomic Analysis Predicts Immunotherapy-related Adverse Events in Gastric Cancer Patients