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NCT Number: NCT05326906

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

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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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hunan Cancer hospital

Changsha, Hunan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PD-1/PD-L1 inhibitors

Drug

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

Primary outcomes

  1. Number of Participants with Immune-Related Hepatitis

    Time frame: 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)

  2. Number of Participants Deaths

    Time frame: 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.

Secondary outcomes

  1. Number of Participants with Laboratory Abnormalities in Liver Tests

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hunan Province Tumor Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Apr 14, 2022
Registry last updated
May 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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