Observing side effects in patients receiving anti-PD1 immunotherapy
A Prospective Study to Observe Adverse Effects in Patients Receiving Anti-PD1 Immunotherapy
This study looks at how anti-PD1 immunotherapy affects patients by tracking any side effects and changes in their immune system.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05669638 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the development of adverse reactions in patients undergoing anti-PD1 immunotherapy. It will focus on assessing the autoantibody profiles of these patients, documenting any adverse reactions they experience, and analyzing changes in immune cells and cytokines. By closely monitoring these factors, the study seeks to enhance understanding of the immune response associated with this treatment. The findings could provide valuable insights into patient safety and treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are currently receiving anti-PD1 immunotherapy.
Not a fit: Patients with unstable vital signs or those with functional impairment of the immune system due to other diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve patient management by identifying and mitigating adverse reactions to anti-PD1 immunotherapy.
How similar studies have performed: While there have been studies on adverse effects of immunotherapy, this specific observational approach focusing on anti-PD1 immunotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Receiving anti-PD1 immunotherapy Exclusion Criteria: 1. Vital signs are unstable 2. Functional impairment of immune system caused by other diseases or other reasons, such as Systemic lupus erythematosus (SLE), AIDS, etc.
Where this trial is running
Beijing, Beijing
- Xuanwu Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Hongyan Li, MD,PhD — Xuanwu Hospital, Beijing
- Study coordinator: Hongyan Li
- Email: hongyanli09@126.com
- Phone: 18600346925
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.