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Exploratory Blood-Based Biomarkers in TACE-Treated Hepatocellular Carcinoma: A Pilot Study

Exploratory Blood-Based Biomarkers in TACE-Treated Hepatocellular Carcinoma: A Pilot Study

Recruiting
18 years and older
All
Phase N/A

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Overview

The goal of this observational study is to evaluate changes in selected biomarkers and their potential connection with early radiological outcomes in adult patients with hepatocellular carcinoma (HCC) who are candidates for TACE treatment. The main questions it aims to answer are whether specific biomarkers change in response to TACE treatment and if there is a correlation between these changes and early radiological treatment response as measured by mRECIST criteria. Participants will undergo standard-of-care Transarterial Chemoembolization (TACE) as decided by a multidisciplinary team and will provide blood samples at predefined, clinically relevant time points, specifically before the first TACE procedure and during subsequent follow-up cycles on the day of either a new TACE or a control CT scan. Additionally, participants will undergo routine clinical and radiological assessments, including multiphase CT or MRI scans four to eight weeks after the procedure to monitor treatment success, with all data being collected from medical records and standard diagnostic procedures

Eligibility

Inclusion Criteria:

  • Age ≥ 18 years.
  • Diagnosis of hepatocellular carcinoma (HCC) based on LI-RADS CT/MRI v2018 criteria or histopathological verification
  • Candidate for TACE as part of standard treatment (BCLC criteria)
  • Child-Pugh score ≤ 7 at the time of TACE indication
  • ECOG performance status 0 at the time of TACE indication
  • Availability of at least one follow-up multiphase CT or MRI scan 4-8 weeks after TACE

Exclusion Criteria:

  • Child-Pugh score ≥8 at the time of TACE indication
  • ECOG performance status \> 0 at the time of TACE indication.
  • Presence of extrahepatic dissemination and/or macrovascular invasion
  • Technically unfeasible TACE (e.g., inability to identify feeder artery)
  • Severe uncorrectable coagulopathy or cytopenia
  • Severe allergy or contraindication to iodine contrast agent or drugs used during TACE
  • Pregnancy or breastfeeding
  • Inability to provide signed informed consent

Study details
    Hepatocellular Carcinoma (HCC)
    Liver Neoplasms

NCT07378709

University of Belgrade

1 February 2026

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