Validation of Blood-Based Biomarkers in TACE-Treated Hepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Belgrade
About this trial
The goal of this prospective observational study is to validate the clinical utility of specific blood-based biomarkers for predicting and monitoring treatment response in patients with hepatocellular carcinoma (HCC) undergoing Transarterial Chemoembolization (TACE).
The study aims to determine if longitudinal changes in these biomarkers can reliably correlate with early radiological treatment response, as measured by Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Participants will receive standard-of-care TACE treatment and will provide blood samples at baseline and during subsequent clinical follow-up cycles. Biomarker levels will be compared against routine multiphase computed tomography (CT) or Magnetic Resonance Imaging (MRI) scans performed four to eight weeks post-procedure to establish their accuracy as predictive tools for clinical success.
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
60 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov