Organoid Models of Hepatocellular Carcinoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Capacity to express informed consent;

Age ≥18 years;

Suspected radiological diagnosis of HCC or diagnosis of HCC with indications for surgical resection.

Disqualifiers

Age < 18 years;

Contraindications to liver biopsy (ascites, platelets<50,000, INR>1.7);

Contraindications to HCC resection surgery;

Active viral infection;

Trial design

Design model

Single group

Treatments tested in this trial

  • organoids models

    Procedure/Surgery

    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.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: HCC organoid models developmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Organoid model development

The primary endpoint of this study is to assess the correlation between the genomic and histological characteristics of patient-derived organoids (PDOs) from hepatocellular carcinoma (HCC) surgical biopsies and clinical outcomes, specifically disease-free survival (DFS) and overall survival (OS).

Time frame
2-18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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