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Liver Toxicity in Lung Cancer Patients Treated With Immune-checkpoint Inhibitors.

NCT04595734 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2022-01-21

No results posted yet for this study

Summary

Immune-checkpoint inhibitors have recently become available as a new therapy for a variety of cancers. This drugs function by boosting the anti-cancer immune response, but unfortunately, may cause off-target, non-specific immune activation, resulting in liver and gut toxicity. In order to understand the development of liver immune-related adverse events we aim to collect full clinicopathological data from patients with advanced lung cancer treated with immune-checkpoint inhibitors at Blacktown, Westmead and Nepean Hospitals. Patients treated with standard chemotherapy will be used as a control group.

This study aims to establish clinical risk factors that can predict the occurrence of liver immune-related adverse events in patients with advanced lung cancer treated with immune-checkpoint inhibitors. Such predictors may assist in the stratification of patients based on their risk for development liver toxicity as a result of immunotherapy, allowing early cessation/modification of treatment prior to the development of severe adverse reactions. In addition, this retrospective study will aim to determine the significance of pre-existing liver damage on the development of liver adverse events as well as establish a timeline defining the development of adverse events in the liver.

Conditions

  • Lung Cancer Stage IV
  • Lung Cancer, Non-small Cell
  • Hepatitis

Interventions

OTHER

No intervention due to observational methods of study

No intervention due to observational methods of study

Sponsors & Collaborators

  • University of Western Sydney

    collaborator OTHER

  • Western Sydney Local Health District

    lead OTHER

Principal Investigators

  • Golo Ahlenstiel, Professor · Blacktown Hospital, Western Sydney Local Health District

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-07
Primary Completion
2023-01-10
Completion
2025-01-06

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04595734 on ClinicalTrials.gov