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RecruitingNot ApplicableNCT06929845

Organoid Models of Hepatocellular Carcinoma

Organoid Models of Hepatocellular Carcinoma to Test Treatment Efficacy, Exploring Correlations With Tumor Microenvironment and Gut-liver-tumor Axis.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

150 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

SurgeryHepatocellular CarcinomaOrganoidsTumor MicroenvironmentGut MicrobiotaSystem Disorders, Digestive

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study creates lab-grown tumor models called "organoids" from tissue taken during liver cancer (hepatocellular carcinoma, or HCC) surgery. These organoids allow researchers to test treatments and better understand each patient's specific cancer. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with or are suspected to have liver cancer (HCC) - You are scheduled for surgical removal of your liver tumor - You are able to provide informed consent **You may NOT be eligible if...** - You are under 18 years old - You have blood clotting problems or fluid build-up in the abdomen that would make a liver biopsy unsafe - You have an active viral infection - You refuse to sign the consent form Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREorganoids 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.

Locations(1)

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

Roma, Italy

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NCT06929845

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