Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Event | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Immunotherapy | — | UNRESOLVED | — |
| Lipidomics | — | UNRESOLVED | — |
| Metabonomics | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Immune-related adverse events（irAEs）group
- description
- 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)
- label
- Non-Immune-related adverse events (Non-irAEs) group
- description
- 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)
Primary outcomes (3)
- measure
- Incidence of immune-related adverse events
- timeFrame
- 1 year
- description
- * 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 studyReferences
Publications (0)
Data not yet available