Status:
RECRUITING
Metabolomic and Lipidomic Analysis Predicts Immunotherapy-related Adverse Events in Gastric Cancer Patients
Lead Sponsor:
Qinghai Red Cross Hospital
Conditions:
Gastric Cancer
Immunotherapy
Eligibility:
All Genders
18-80 years
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 pa...
Detailed Description
This study is designed as a prospective clinical trial employing advanced metabolomics and lipidomics methodologies to comprehensively analyze alterations in metabolites and lipid molecules within pla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 22 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06915389
Start Date
February 22 2025
End Date
June 30 2027
Last Update
April 8 2025
Active Locations (1)
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1
Qinghai Red Cross Hospital
Xining, Qinghai, China, 810000