Organoid Models of Hepatocellular Carcinoma

NCT06929845 | Recruiting

• 1 other identifier: 6845
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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).

  2-18 months

Study Arms (1)

HCC organoid models development

EXPERIMENTAL

The aim of the present project is to develop a HCC organoid model that closely resembles the in vivo immunological microenvironment, including the contribution of the gut-liver axis. These reconstituted HCC models will then allow us to test tumor sensitiv

Procedure: organoids models

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.

HCC organoid models development

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capacity to express informed consent;
• Age ≥18 years;
• Suspected radiological diagnosis of HCC or diagnosis of HCC with indications for surgical resection.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC CEMAD, Largo A. Gemelli, 8

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Digestive System Diseases

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Liver Diseases

Study Officials

• Francesca Romana Ponziani, PI

  Fondazione Policlinico A. Gemelli IRCCS, Rome, Largo A. Gemelli, 8

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Romana Ponziani, PI

CONTACT

3471227242; francescaromana.ponziani@policlinicogemelli.it

Elisabetta Creta, SC

CONTACT

3480778584; elisabetta.creta@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: April 16, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-03

Locations

IT (1)