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

Completed

• Conditions: Lung Cancer

• Registration Number: NCT05326906
• Lead Sponsor: Hunan Province Tumor Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Primary Completion: 2021-05-01
• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-14
• Status Verified: 2022-05
• Study Completion: 2022-05-01
• Last Update Submitted: 2022-05-13
• Last Update Posted: 2022-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hunan Cancer hospital; 🇨🇳 Changsha, Hunan, China