Clinical trial · Interventional
Liver Cancer and Immunotherapy in the Liquid Biopsy Era
Liver Cancer and Immunotherapy : Clinical Relevance of LIquid BioPSY
NCT05810402CI-TRIAL-00091965LILIPSYrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BCLC Stage B Hepatocellular Carcinoma | BCLC Stage B Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| BCLC Stage C Hepatocellular Carcinoma | BCLC Stage C Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Immune Checkpoint Inhibitor | — | UNRESOLVED | — |
| Liquid Biopsy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liquid Biopsy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BCLC B and C HCC patients
- description
- For each participant, 30mL of blood will be collected at inclusion/before treatment initiation (baseline) and during standard of care follow-up. The blood sample will be taken, in consultation or in outpatient clinic during a blood test for health purposes.
- interventionNames
- Biological: Liquid Biopsy
Primary outcomes (1)
- measure
- Percentage of patients with CTCs-PD-L1+ by CellSearch® technique
- timeFrame
- At inclusion
- description
- A CTC is being defined as: EpCAM(+)/PanCK(+)/Dapi(+)/CD45(-). The PD-L1 status will be observed only on these cells. CTC-PD-L1- = 0 vs CTC-PD-L1+ ≥1
Secondary outcomes (9)
- measure
- Number of CTCs-PD-L1+ measured by CellSearch® technique
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 Security system; * Vulnerable persons according to article L1121-6 of the CSP ; * Persons of full age who are protected or unable to give their consent according to article L1121-8 of the CSP; * Pregnant or breastfeeding women according to article L1121-5 of the CSP. * Non-inclusion due to follow-up difficulties (transfer, insufficient motivation, poor compliance, priority associated pathology in care, etc.)
References
Publications (25)
- BACKGROUNDPantel K, Alix-Panabieres C. Tumour microenvironment: informing on minimal residual disease in solid tumours. Nat Rev Clin Oncol. 2017 Jun;14(6):325-326. doi: 10.1038/nrclinonc.2017.53. Epub 2017 Apr 11. No abstract available. PMID 28397823
- BACKGROUNDMeng S, Tripathy D, Frenkel EP, Shete S, Naftalis EZ, Huth JF, Beitsch PD, Leitch M, Hoover S, Euhus D, Haley B, Morrison L, Fleming TP, Herlyn D, Terstappen LW, Fehm T, Tucker TF, Lane N, Wang J, Uhr JW. Circulating tumor cells in patients with breast cancer dormancy. Clin Cancer Res. 2004 Dec 15;10(24):8152-62. doi: 10.1158/1078-0432.CCR-04-1110. PMID 15623589
- BACKGROUNDLeone K, Poggiana C, Zamarchi R. The Interplay between Circulating Tumor Cells and the Immune System: From Immune Escape to Cancer Immunotherapy. Diagnostics (Basel). 2018 Aug 30;8(3):59. doi: 10.3390/diagnostics8030059. PMID 30200242
- BACKGROUNDAlix-Panabieres C, Pantel K. Liquid Biopsy: From Discovery to Clinical Application. Cancer Discov. 2021 Apr;11(4):858-873. doi: 10.1158/2159-8290.CD-20-1311. PMID 33811121
- BACKGROUNDAlix-Panabieres C. The future of liquid biopsy. Nature. 2020 Mar;579(7800):S9. doi: 10.1038/d41586-020-00844-5. No abstract available. PMID 32214259
- BACKGROUNDEslami-S Z, Cortes-Hernandez LE, Alix-Panabieres C. The Metastatic Cascade as the Basis for Liquid Biopsy Development. Front Oncol. 2020 Jul 21;10:1055. doi: 10.3389/fonc.2020.01055. eCollection 2020. PMID 32850309
- BACKGROUNDMego M, Gao H, Cohen EN, Anfossi S, Giordano A, Sanda T, Fouad TM, De Giorgi U, Giuliano M, Woodward WA, Alvarez RH, Valero V, Ueno NT, Hortobagyi GN, Cristofanilli M, Reuben JM. Circulating Tumor Cells (CTC) Are Associated with Defects in Adaptive Immunity in Patients with Inflammatory Breast Cancer. J Cancer. 2016 Jun 3;7(9):1095-104. doi: 10.7150/jca.13098. eCollection 2016.