Hepatitis Clinical Trial
Official title:
A Retrospective Study of Clinical Outcomes and Liver-related Toxicity of Patients With Lung Cancer Treated With Immune-checkpoint Inhibitors
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | January 6, 2025 |
Est. primary completion date | January 10, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. - Advanced lung cancer (stage IV) 2. - Treatment - immune-checkpoint inhibitors or chemotherapy 3. - Data is fully available for the whole period of observation Exclusion Criteria: 1. - Radiologically reported liver metastases 2. - Concurrent treatment with both therapeutic regimes |
Country | Name | City | State |
---|---|---|---|
Australia | Blacktown Hospital | Sydney | New South Wales |
Australia | Nepean Hospital | Sydney | New South Wales |
Australia | Westmead Hospital | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Western Sydney Local Health District | University of Western Sydney |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with immune-mediated hepatitis | Week 6-12 from treatment commencement | ||
Primary | Baseline risk factors significantly correlated with hepatic immune-related adverse events | Blood test results, BMI, FibroScan data will be correlated with the development of liver toxicity | Week 0 | |
Secondary | Number of participants with non-hepatic immune-related adverse events | Week 3-32 from treatment commencement | ||
Secondary | Baseline risk factors significantly correlated with non-hepatic immune-related adverse events | Blood test results and BMI will be correlated with the development of immune-related adverse events (non-hepatic) | Week 0 |
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