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RECRUITING Not applicable ClinicalTrials.gov

Organoid Models of Hepatocellular Carcinoma

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS • ClinicalTrials.gov ID: NCT06929845

Registry updated: 2026-09-21
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Description

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.

Interventions

  • organoids models (Procedure)
    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.

Eligibility criteria

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.

Conditions

Hepatocellular Carcinoma Organoids Gut Microbiota Tumor Microenvironment System Disorders, Digestive Surgery

Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD, Largo A. Gemelli, 8 — Roma, Italy
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record