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

NCT04595734 | Unknown

• 1 other identifier: 2019/PID14816
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Immune-checkpoint inhibitors; Lung cancer; Nivolumab; Pembrolizumab; Durvalumab

Outcome Measures

Primary Outcomes (2)

• Number of participants with immune-mediated hepatitis

  Week 6-12 from treatment commencement

• 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 Outcomes (2)

• Number of participants with non-hepatic immune-related adverse events

  Week 3-32 from treatment commencement

• Baseline risk factors significantly correlated with non-hepatic immune-related adverse events

  Week 0

Interventions

No intervention due to observational methods of study OTHER

No intervention due to observational methods of study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lung cancer treated with immune-checkpoint inhibitors at Blacktown and Westmead Public Hospitals of the Western Sydney Local Health District and Nepean Hospital of the Nepean and Blue Mountains Local Health District.

You may qualify if:

• \- Advanced lung cancer (stage IV)
• \- Treatment - immune-checkpoint inhibitors or chemotherapy
• \- Data is fully available for the whole period of observation

You may not qualify if:

• \- Radiologically reported liver metastases
• \- Concurrent treatment with both therapeutic regimes

Sponsors & Collaborators

• Western Sydney Local Health District: lead
• University of Western Sydney: collaborator

Study Sites (3)

Westmead Hospital

Sydney, New South Wales, 2145, Australia

RECRUITING

Blacktown Hospital

Sydney, New South Wales, 2148, Australia

RECRUITING

Nepean Hospital

Sydney, New South Wales, 2747, Australia

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Hepatitis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Liver Diseases; Digestive System Diseases

Study Officials

• Golo Ahlenstiel, Professor

  Blacktown Hospital, Western Sydney Local Health District

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Golo Ahlenstiel, Professor

CONTACT

+61 432 303 547; Golo.Ahlenstiel@health.nsw.gov.au

Dmitrii Shek, Dr

CONTACT

+61 412 035 533; Dmitri.Shek@health.nsw.gov.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: January 7, 2020
• Primary Completion: January 10, 2023
• Study Completion: January 6, 2025
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

AU (3)