Liver Cancer and Immunotherapy in the Liquid Biopsy Era — LILIPSY  

Hepatocellular Carcinoma Clinical Trial

Official title: Liver Cancer and Immunotherapy : Clinical Relevance of LIquid BioPSY

Status Not yet recruiting

Clinical Trial Summary

The goal of this prospective clinical trial is to identify a predictive biomarker in patients with advanced HCC (stage B and C) using a combinatorial approach of the liquid biopsy.

The main questions it aims to answer are:

• Is multi-omic liquid biopsy approach able to identify a strong predictive biomarker of immunotherapy efficiency?

• Is there a correlation between tissue biopsy (PD-L1 tissue level of expression) and liquid biopsy (detection of CTC expressing PD-L1) in HCC patients?

Participants blood will be collected at several time points.

Clinical Trial Description

In solid cancers, some more aggressive tumor cells actively detach from the primary lesion and then travel through the circulating compartment to reach distant organs and form micro-metastases. Detecting CTCs in the blood is also relevant for assessing tumor progression, prognosis and therapeutic follow-up. The non-invasive, highly sensitive for CTCs analysis is called "liquid biopsy". Over the past few years, a multi-analyses approach (CTCs, circulating tumor DNA, extracellular vesicles, miRNA...) of liquid biopsy has been developed.

Hepatocellular carcinoma (HCC) is the predominant pathological type of primary liver cancer. It represents the sixth most common incidence worldwide and the third most common cause of cancer mortality.

Since 2021, the gold standard treatment for patients with advanced and/or unresectable HCC is the combination of atezolizumab (anti-PD-L1) and bevacizumab (VEGF inhibitor) in cases where chemoembolization is not indicated (patients with lymph node invasion and/or distant lesions or patients with portal flow abnormality). Indeed, this therapy offers a significant benefit in overall survival (19.2 vs 13.4 months, HR 0.66, p<0.0009) as well as in progression-free survival (6.9 vs 4.3 months, HR 0.65, p=0.0001). However, to date, there is no predictive biomarker for the efficacy of immune checkpoint inhibitors (ICI)

The purpose of this research project is to identify a predictive biomarker in patients with advanced HCC (stage B and C) using a combinatorial approach of the liquid biopsy (CTC, CTC expressing PD-L1, immune cell profiling). ;

Related Conditions & MeSH terms

• BCLC Stage B Hepatocellular Carcinoma
• BCLC Stage C Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Immune Checkpoint Inhibitor
• Liquid Biopsy
• Liver Neoplasms

• NCT number: NCT05810402
• Study type: Interventional
• Source: University Hospital, Montpellier
• Contact: Thomas Bardol, M.D.
• Phone: +33682882757
• Email: t-bardol@chu-montpellier.fr
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Completion date: May 2027