The Prediction Biomarkers of Survival Outcome for Severe Immune-related Hepatitis

Hunan Province Tumor Hospital

Status: Completed

Conditions: Lung Cancer

Treatments: Drug: PD-1/PD-L1 inhibitors

Study type: Observational

Funder types: Other

Identifiers

NCT05326906

STEM

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.