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 volunteersQualifiers
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
Single group
Treatments tested in this trial
organoids models
Procedure/SurgeryEnrolled 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
Trial outcomes
Primary outcomes
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).
Sponsors and contacts
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