RecruitingNCT06915389

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

Sponsor

Qinghai Red Cross Hospital

Enrollment

100 participants

Start Date

Feb 22, 2025

Study Type

OBSERVATIONAL

Conditions

Gastric Cancer Immunotherapy Adverse Event Metabonomics Lipidomics

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether analyzing a patient's blood chemistry (metabolomics and lipidomics) before immunotherapy can predict who is likely to experience side effects from PD-1/PD-L1 inhibitor drugs used to treat stomach cancer. It is an observational study — meaning researchers collect and analyze samples rather than test a new treatment. **You may be eligible if...** - You are 18 or older with a diagnosis of gastric (stomach) cancer confirmed by lab testing - You are about to start PD-1/PD-L1 immunotherapy for the first time - Your general health status is acceptable (ECOG score 0-2) - Your expected survival is at least 3 months - You are willing to follow the study plan and provide a blood sample before treatment **You may NOT be eligible if...** - You refuse immunotherapy treatment - Pre-treatment blood samples cannot be collected - You have an autoimmune disease - You have serious pre-existing heart, lung, thyroid, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Locations(1)

Qinghai Red Cross Hospital

Xining, Qinghai, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06915389

Related Trials

Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis

NCT045579691 location

Lead-212 PSV359 Therapy for Patients With Solid Tumors

NCT067107567 locations

Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)

NCT0671013281 locations

Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers

NCT028388361 location

A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

NCT0614703715 locations