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Clinical Trials in Italy / NCT06929845
Recruiting Not applicable

Organoid Models of Hepatocellular Carcinoma

NCT06929845 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-10-01
Last updated
2026-09-21

Condition(s) studied

Hepatocellular CarcinomaOrganoidsGut MicrobiotaTumor MicroenvironmentSystem Disorders, DigestiveSurgery

Investigational drug(s) / intervention(s)

organoids models

organoids models: Enrolled patients will undergo liver biopsy with sampling of tumor tissue and adjacent nontumor liver parenchyma. Alternatively, patients who are candidates for surgical resection of HCC will be enrolled. The tumor tissue obtained will be used partly for histological confirmation of HCC and then included in kerosene, partly used for organoid construction, and the nontumor tissue will be used solely for organoids. Genomic and transcriptomic changes resulting from the integration of PDO of HCC with the gut microbiota and host immune cells derived from the patient will be evaluated. In addition, PDOs from HCC will be tested for the efficacy of systemic therapies (ICI and TKI) and understand possible modifying co-factors.

Study summary

A promising tool to elucidate the molecular characteristics of HCC are patient-derived organoids (PDOs), three-dimensional cultures of cells that self-organise according to tissue-specific patterns and can be used to test the susceptibility of a specific tumour to anticancer agents. In this study, PDOs for HCC will be developed that closely resemble the tumour microenvironment in vivo and mimic the crosstalk of the gut-liver axis to establish a correlation with patient prognosis and test the efficacy of available systemic therapies.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Capacity to express informed consent; * Age ≥18 years; * Suspected radiological diagnosis of HCC or diagnosis of HCC with indications for surgical resection. Exclusion Criteria: * Age \< 18 years; * Contraindications to liver biopsy (ascites, platelets\<50,000, INR\>1.7); * Contraindications to HCC resection surgery; * Active viral infection; * Refusal to sign informed consent to participate in the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD, Largo A. Gemelli, 8 Roma Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06929845 on ClinicalTrials.gov ↗ ← All trials in Italy