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

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

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 Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: PD-1/PD-L1 inhibitors

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Hunan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with immuntherapy underwent severe Immune-related Hepatitis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hunan Province Tumor Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immune Checkpoint Inhibitors
• Other Study ID Numbers: STEM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No