Clinical trial · Observational
Liver Toxicity in Lung Cancer Patients Treated With Immune-checkpoint Inhibitors.
A Retrospective Study of Clinical Outcomes and Liver-related Toxicity of Patients With Lung Cancer Treated With Immune-checkpoint Inhibitors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatitis | — | UNRESOLVED | — |
| Lung Cancer, Non-small Cell | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Lung Cancer Stage IV | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention due to observational methods of study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Number of participants with immune-mediated hepatitis
- timeFrame
- Week 6-12 from treatment commencement
- measure
- Baseline risk factors significantly correlated with hepatic immune-related adverse events
- timeFrame
- Week 0
- description
- Blood test results, BMI, FibroScan data will be correlated with the development of liver toxicity
Secondary outcomes (2)
- measure
- Number of participants with non-hepatic immune-related adverse events
- timeFrame
- Week 3-32 from treatment commencement
- measure
- Baseline risk factors significantly correlated with non-hepatic immune-related adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available