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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Incidence of immune-related adverse events — 1 year * For gastric cancer patients receiving immunotherapy for the first time, immune-related adverse events should be monitored during treatment, with a follow-up period of 1 year.
* The immune checkpoint inhibitors include pembrolizumab, nivolumab, sintilimab, tislelizumab, sugemalimab and camrelizumab.
* NCCN Guidelines for Management of Immunotherapy-Related Toxicity are adopted as the gold standard for assessing immune-related adverse events.
* The severity of immune-related adverse events was evaluated based on the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Changes in Plasma Metabolite Levels — 1 year * A comprehensive metabolomic profiling of plasma in treatment-naïve gastric cancer patients undergoing immunotherapy: Investigating metabolic disparities between responders with immune-related adverse events and those without.
* The measurement methods include gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS).
* The measured metabolites include amino acids, fatty acids, glucose, lactate, nucleotides, organic acids, vitamins and small-molecule metabolites.
* All metabolomic markers in plasma will be reported as relative quantitative values in arbitrary units.
* Baseline plasma samples were collected from all patients prior to immunotherapy, and follow-up samples were obtained every 2 treatment cycles until 1 year after treatment initiation.
Changes in Plasma Lipid Levels — 1 year * Comprehensive lipidomic profiling of plasma from gastric cancer patients undergoing initial immunotherapy was performed to investigate differential plasma lipid signatures between those who developed immune-related adverse events and those who did not.
* The measurement methods include gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS).
* The measured lipids include triglycerides, cholesterol, phospholipids, fatty acids, ceramides, steroids, fatty acid derivatives, and other sphingolipids.
* All plasma lipidomic markers will be reported as relative quantitative values in arbitrary units.
* Baseline plasma samples were collected from all patients prior to immunotherapy, with subsequent samples obtained every 2 treatment cycles until 1 year of therapy.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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