Liver Cancer and Immunotherapy in the Liquid Biopsy Era
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 immunoth
| Condition(s) | Hepatocellular Carcinoma, BCLC Stage B Hepatocellular Carcinoma, BCLC Stage C Hepatocellular Carcinoma, Immune Checkpoint Inhibitor, Liquid Biopsy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Patients of at least 18 years old, * Patients with advanced hepatocellular carcinoma or HCC with indication for first-line PD-1 or PD-L1 immunotherapy in MDT, without prior systemic therapy, * The diagnosis of HCC is established according to imaging criteria (LI-RADSv2018 criteria) or after histological evidence, * Advanced HCC defined by BCLC stages B and C, * Patients with oral consent. Exclusion Criteria: * Administration of a previous systemic anti-tumor treatment (immunotherapy or chemotherapy or targeted therapy) * No personal history of neoplasia in the previous 5 years * No personal history of systemic inflammatory diseases * No immunosuppressive treatment or treatment that could modify immunity (anti-TNF...) * No affiliation or non-beneficiary of a Social Sec |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University Hospital, Montpellier |
| Locations | Montpellier, France |
| Start date | 2023-06-28 |
| NCT ID | NCT05810402 |
| Official listing | https://clinicaltrials.gov/study/NCT05810402 |