Exploratory Blood-Based Biomarkers in TACE-Treated Hepatocellular Carcinoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Belgrade

About this trial

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 Transarterial Chemoembolization (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 Modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria. Participants will undergo standard-of-care 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 Computed Tomography (CT) scan. Additionally, participants will undergo routine clinical and radiological assessments, including multiphase CT or Magnetic Resonance Imaging (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 criteria

Qualifiers

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

Disqualifiers

Child-Pugh score ≥8 at the time of TACE indication

Eastern Cooperative Oncology Group (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)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

15 Participants
are grouped into 1 trial group

Sponsors and collaborators