Validation of Blood-Based Biomarkers in TACE-Treated Hepatocellular Carcinoma

Starting soon

Conditions studied: Hepatocellular Carcinoma (HCC), Liver Neoplasms

In brief

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.

Key facts

Study ID

NCT07414433

Run by

University of Belgrade

People needed

60

Starts

2026-03-01

Expected to finish

2029-12-30

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)
• 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

Where it is running

• KBC Bežanijska kosa — Belgrade, Serbia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.