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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2022-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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PD-1/PD-L1 inhibitors

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No