NCT06915389 Metabolomic and Lipidomic Analysis Predicts Immunotherapy-related Adverse Events in Gastric Cancer Patients
| NCT ID | NCT06915389 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Qinghai Red Cross Hospital |
| Condition | Gastric Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-02-22 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-02-22 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Frequently Asked Questions
Who can join the NCT06915389 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06915389 currently recruiting?
Yes, NCT06915389 is actively recruiting participants. Visit ClinicalTrials.gov or contact Qinghai Red Cross Hospital to inquire about joining.
Where is the NCT06915389 trial being conducted?
This trial is being conducted at Xining, China.
Who is sponsoring the NCT06915389 clinical trial?
NCT06915389 is sponsored by Qinghai Red Cross Hospital. The trial plans to enroll 100 participants.
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