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

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

About This Trial

This study comprehensively examines metabolic and lipidomic dynamics in gastric cancer patients initiating PD-1/PD-L1 inhibitor therapy, employing a longitudinal design with pre- and post-treatment patients. The primary objectives include identifying irAE-associated metabolic and lipid biomarkers, developing predictive risk models, and evaluating the prognostic value of these molecular profiles. The findings are expected to contribute significantly to personalized treatment strategies and improved clinical decision-making in immunooncology.

Who May Be Eligible (Plain English)

Who May Qualify: - Age≥ 18 years - ECOG PS 0-2 - Gastric cancer diagnosed by histology or cytology - Untreatment with PD-1/PD-L1 inhibitors - Expected survival≥3 months - Exhibits a favorable adherence to treatment and follow-up,demonstrates compliance with the research protocol, and willingly signs the willing to sign a consent form form. Who Should NOT Join This Trial: - Unable to obtain an organization or due to insufficient organizational material, unable to diagnose gastric cancer - Refusal to receive PD-1/PD-L1 inhibitor treatment - Baseline (before immunotherapy) plasma samples are unavailable - Combined with autoimmune conditions (where your immune system attacks your own body)s - Baseline (before immunotherapy) there are severe diseases in the heart, lungs, thyroid gland and other organs - Baseline (before immunotherapy) there are severe abnormalities in liver and kidney functions, pancreatic enzymes and other indicators ⑦ Researchers posit that any condition deemed potentially harmful to the subjects or that might prevent subjects from meeting or adhering to the research requirements shall not be permissible for inclusion in this study Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Age≥ 18 years * ECOG PS 0-2 * Gastric cancer diagnosed by histology or cytology * Untreatment with PD-1/PD-L1 inhibitors * Expected survival≥3 months * Exhibits a favorable adherence to treatment and follow-up,demonstrates compliance with the research protocol, and willingly signs the informed consent form. Exclusion Criteria: * Unable to obtain an organization or due to insufficient organizational material, unable to diagnose gastric cancer * Refusal to receive PD-1/PD-L1 inhibitor treatment * Baseline (before immunotherapy) plasma samples are unavailable * Combined with autoimmune diseases * Baseline (before immunotherapy) there are severe diseases in the heart, lungs, thyroid gland and other organs * Baseline (before immunotherapy) there are severe abnormalities in liver and kidney functions, pancreatic enzymes and other indicators ⑦ Researchers posit that any condition deemed potentially harmful to the subjects or that might prevent subjects from meeting or adhering to the research requirements shall not be permissible for inclusion in this study

Locations (1)

Qinghai Red Cross Hospital

Xining, Qinghai, China