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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05326906
• Other study ID #: STEM
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2022
• Source: Hunan Province Tumor Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Hunan Cancer hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 years
Primary	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.	2 years
Secondary	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	2 years