Identifying risk factors for lung complications in cancer patients treated with immunotherapy and radiation
The Risk Factors for Acute Radiation Pneumonitis in Patients With Prior Receipt of Immune Checkpoint Inhibitors.in Real-world Clinical Practice: a Multicenter, Prospective, Open, Non-interventional Study
This study looks at cancer patients who have had immunotherapy and radiation to see what factors might increase their risk of developing lung complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Sex | All |
| Sponsor | Hubei Cancer Hospital Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05219851 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on the incidence of acute radiation pneumonitis (aRPs) in cancer patients who have previously received immune checkpoint inhibitors (ICIs) and subsequently underwent thoracic intensity-modulated radiotherapy. The study will analyze various risk factors, particularly dosimetric factors, that may contribute to the development of aRPs. Additionally, it seeks to establish a predictive model to guide clinical treatment decisions for affected patients.
Who should consider this trial
Good fit: Ideal candidates include cancer patients with confirmed malignant tumors who have previously received immune checkpoint inhibitors and are scheduled for thoracic radiotherapy.
Not a fit: Patients who have not received immunotherapy prior to thoracic radiotherapy or those undergoing non-thoracic radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify at-risk patients and improve management strategies for those undergoing radiotherapy after immunotherapy.
How similar studies have performed: While there is ongoing research into the effects of immunotherapy and radiotherapy, this specific focus on acute radiation pneumonitis in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pathologically or cytologically confirmed malignant tumor 2. Cancer patients with previously received ICIs underwent thoracic intensity-modulated radiotherapy Exclusion Criteria: 1. Cancer patients did not receive immunotherapy before thoracic intensity-modulated radiotherapy 2. Non-thoracic radiotherapy patients
Where this trial is running
Wuhan, Hubei
- Hubei Cancer Hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Guang Han, MD.;Ph.D
- Email: hg7913@hotmail.com
- Phone: 13886048178
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.