Lung Cancer Clinical Trial
— HEPATICIOfficial title:
Significance of Hepatic Biomarkers in the Evaluation of Response to Treatment and Prognosis in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors
Verified date | July 2023 |
Source | Centre Hospitalier Universitaire, Amiens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 1, 2023 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens | Amiens |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | basal ALT blood concentration in lung cancer patients treated with ICI determined | To Identify baseline blood ALT concentration as a predictive liver biomarker of treatment response in lung cancer patients treated with ICI. | one year |
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