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

Lung Cancer Clinical Trial

— HEPATICI  

Official title:

Significance of Hepatic Biomarkers in the Evaluation of Response to Treatment and Prognosis in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05653531
• Other study ID #: PI2021_843_0230
• Status: Withdrawn
• Phase: N/A
• Start date: October 25, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn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

Related Conditions & MeSH terms

• Immune Checkpoint Inhibitor
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Blood sample
Liver blood tests (AST, ALT, PAL, GGT, bilirubin, PT) will be performed before each ICI injection during the first three injections and again at 6 months.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

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