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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Qinghai Red Cross Hospital
RECRUITING
Xining
Time Frame
Start Date: 2025-02-22
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 100
Treatments
Immune-related adverse events(irAEs)group
Integrated metabolomic and lipidomic profiling was conducted to delineate the differential metabolic signatures and lipidomic alterations prior to PD-1/PD-L1 inhibitor therapy initiation and throughout the progression of immune-related adverse events (irAEs)
Non-Immune-related adverse events (Non-irAEs) group
Integrated metabolomic and lipidomic profiling was conducted to delineate the differential metabolic signatures and lipidomic alterations prior to PD-1/PD-L1 inhibitor therapy initiation and throughout the progression of immune-related adverse events (irAEs)
Related Therapeutic Areas
Sponsors
Leads: Qinghai Red Cross Hospital

This content was sourced from clinicaltrials.gov