Analyzing metabolic changes to predict side effects in gastric cancer immunotherapy
Official title: 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
Run by Qinghai Red Cross Hospital · NCT06915389 · Data updated 2026-11-12
This study is trying to see if changes in blood samples from gastric cancer patients receiving immunotherapy can help predict side effects they might experience from the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Qinghai Red Cross Hospital Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 1 site (Xining, Qinghai) |
| Status | Recruiting |
| Started | February 22, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | April 8, 2025 |
| Trial ID | NCT06915389 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a confirmed diagnosis of gastric cancer who have not yet received PD-1/PD-L1 inhibitors.
✕Probably not a fit
Patients with autoimmune diseases or severe organ dysfunctions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the metabolic and lipidomic changes in gastric cancer patients undergoing PD-1/PD-L1 inhibitor therapy. By collecting and analyzing plasma samples before and after treatment, the study aims to identify biomarkers associated with immune-related adverse events (irAEs). The goal is to develop predictive models that can enhance clinical decision-making and personalize treatment strategies for patients. Participants will be matched based on age, sex, and cancer stage to ensure robust comparisons between those who experience irAEs and those who do not.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction and management of adverse events in gastric cancer patients receiving immunotherapy.
How similar studies have gone: While similar studies have explored metabolic profiling in cancer therapies, this specific approach focusing on gastric cancer and irAEs is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Qinghai Red Cross Hospital
Xining, Qinghai, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.