Identifying biomarkers for immune checkpoint inhibitor effectiveness and side effects in cancer patients
Discovery of Biomarkers Related to the Efficacy and Adverse Reactions of Immune Checkpoint Inhibitors Based on Metabolism-genomics
This study is trying to find specific markers in the blood of cancer patients to see how well immune checkpoint inhibitors work and what side effects they might cause.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Beijing Chao Yang Hospital Academic / other |
| Drugs / interventions | immunotherapy, radiation, prednisone |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04656119 on ClinicalTrials.gov |
What this trial studies
This observational study aims to discover biomarkers related to the efficacy and adverse reactions of immune checkpoint inhibitors (ICIs) in cancer patients. Researchers will collect peripheral blood samples from participants at baseline and at regular intervals over approximately 30 weeks. The samples will be analyzed using genomics and metabonomics techniques to identify potential biomarkers associated with immune-related adverse events (irAEs) and clinical efficacy. A prediction model may be developed using machine learning once sufficient data is collected.
Who should consider this trial
Good fit: Ideal candidates include cancer patients with histologically confirmed malignant tumors who are receiving ICIs for the first time or have previously received ICIs without experiencing immune-related adverse reactions.
Not a fit: Patients with active autoimmune diseases, those on long-term corticosteroid therapy, or individuals with certain cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies that improve the effectiveness of ICIs while minimizing adverse effects for cancer patients.
How similar studies have performed: Other studies have shown promise in identifying biomarkers related to immunotherapy, but this specific approach combining genomics and metabonomics is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed malignant tumor, no relative contraindications for immunotherapy, in line with the standards of immunotherapy * Receive immune checkpoint inhibitors (ICIs) for the first time or have received ICIs but no immune-related adverse reactions have occurred * Have provided informed consent, are willing to participate in study and routine follow-up * At least one measurable lesion according to Guidelines for response criteria for use in trials testing immunotherapeutics (iRECIST) Exclusion Criteria: * Active, known, suspected or a documented history of autoimmune disease * Eastern Cooperative Oncology Group(ECOG) performance status 3-4 * Long-term hormone therapy，corticosteroids (\>10mg/day prednisone curative dose) * Subjects with human immunodeficiency virus (HIV) * Subjects with other tumors * Myocardial infarction, poorly control led arrhythmia, New York Heart Association (NYHA) standard III-IV cardiac insufficiency or left ventricular ejection fraction (LVEF)\<50% in the last 6 month * Active tuberculosis * Active or a documented history of interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function * Common Terminology Criteria for Adverse Events (CTCAE) peripheral neuropathy grade≥2 * History of alcohol abuse
Where this trial is running
Beijing, Beijing
- Beijing Chao-yang Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Wenchao Lu, Master
- Email: wenchaolu621@163.com
- Phone: 18811183790
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.