Clinical Significance of Hepatic Biomarkers in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors (HEPATICI)

Centre Hospitalier Universitaire, Amiens

Status: Withdrawn

Conditions: Liver Biomarkers; Immune Checkpoint Inhibitor; Lung Cancer; Transaminases

Treatments: Other: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT05653531

PI2021_843_0230

Details and patient eligibility

About

Lung cancer is the leading cause of cancer death worldwide. The emergence of immune checkpoint inhibitors (ICIs) has revolutionized the treatment of lung cancer over the past 10 years. Nivolumab, ipilimumab, pembrolizumab, atezolizumab, and durvalumab have been successively approved in non-small cell lung cancer, small cell lung cancer, and pleural mesothelioma. Although the efficacy of ICIs is remarkable in some patients, the objective response rate is only about 20%. The development of predictive biomarkers for treatment response is essential. Non-invasive methods and easily accessible biomarkers at low cost are required.ICIs activate the immune system through the inhibition of checkpoints (PD-L1, PD-1). The immune system and the liver are interconnected and constantly interact through a complex regulatory system. Patients with lung cancer frequently suffer from liver damage, due to metastases, treatments or underlying pathologies. The objective of the study is to evaluate the clinical significance of key liver biomarkers (AST, ALT, PAL, GGT, bilirubin, PT) in patients with lung cancer treated with ICI.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inclusion criteria:
• Age > 18 years
• Patient with lung cancer of any histological type
• Initiation of ICI therapy
• Signed consent for the study

Exclusion criteria

• Patient with previous ICI treatment

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind