Lung Cancer
Conditions
Brief 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.
Interventions
PD-1/PD-L1 inhibitors (the dosage calculation according to dosing instructions)
Sponsors
Hunan Province Tumor Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The lung cancers were diagnosed by pathological evaluation. * The PD-1/PD-L1 inhibitors were administered in all patients. * Grade 3-5 immune-related hepatitis had occurred. * The pre-treatment tissues or peripheral blood were available.
Exclusion criteria
* The pathological type was not lung cancers. * Grade 1-2 immune-related hepatitis would be excluded. * The any-grade hepatitis were induced by chemotherapy or virus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Immune-Related Hepatitis | 2 years | Number of participants with Grade 3-4 IRH graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.0) |
| Number of Participants Deaths | 2 years | Number of participants with Grade 3-4 immune-related hepatitis by CTCAE 4.0 who still died after the corticosteroid (2mg/kg) and/or mycophenolate mofetil treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Laboratory Abnormalities in Liver Tests | 2 years | Number of participants with laboratory liver tests based on Hunan Cancer hospital to determine the safety of immunotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: ALT or AST \>5-20 ULN, and \> 20 x ULN;Total bilirubin \> 3-10 ULN and \> 10 x ULN |
Countries
China
Outcome results
None listed