Trials / Completed
CompletedNCT05326906
The Prediction Biomarkers of Survival Outcome for Severe Immune-related Hepatitis
The Prediction Biomarkers of Survival Outcome for Severe Immune-related Hepatitis in Lung Cancer
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (actual)
- Sponsor
- Hunan Province Tumor Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Immune checkpoint inhibitors have revolutionized lung cancer (LC) treatment, demonstrating a significant improvement in overall survival. However high-grade immune-related adverse events (irAEs) may result in harmful and serious clinical outcomes, even death. Immune-related hepatitis (IRH) is a potentially serious complication of checkpoint blockade, with an incidence of 5%-10% for ICIs monotherapy, including 1%-2% with grade 3 or higher. Therefore, it is particularly important to explore new and better prognostic and predictive biomarkers for IRH.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PD-1/PD-L1 inhibitors | PD-1/PD-L1 inhibitors (the dosage calculation according to dosing instructions) |
Timeline
- Start date
- 2018-05-01
- Primary completion
- 2021-05-01
- Completion
- 2022-05-01
- First posted
- 2022-04-14
- Last updated
- 2022-05-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05326906. Inclusion in this directory is not an endorsement.