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

Hunan Province Tumor Hospital20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lung Cancer

Interventions

PD-1/PD-L1 inhibitorsDRUG

PD-1/PD-L1 inhibitors (the dosage calculation according to dosing instructions)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hunan Cancer hospital

Changsha, Hunan, China

Outcomes

Primary Outcomes

Number of Participants with Immune-Related Hepatitis

Number of participants with Grade 3-4 IRH graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Time frame: 2 years

Number of Participants Deaths

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.

Time frame: 2 years

Secondary Outcomes

Number of Participants with Laboratory Abnormalities in Liver Tests

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

Time frame: 2 years

Data from ClinicalTrials.gov

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