Fact CheckerSign in

NCT07414433Not yet recruiting

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

Blood-Based Biomarkers for Prediction and Monitoring of Response to TACE in Hepatocellular Carcinoma

Source: ClinicalTrials.gov · Last updated 17 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
60 (estimated)
First submitted
9 Feb 2026
Start date
1 Mar 2026
Primary completion date
30 Mar 2029
Lead sponsor
University of Belgrade
NCT number
NCT07414433

What you commit to

  • Study type: Observational
  • Planned participants: 60
  • From 1 Mar 2026 to the primary completion date, 30 Mar 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Severe allergy or contraindication to iodine contrast agent or drugs used during TACE

Other

  • 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
  • Pregnancy or breastfeeding
  • Inability to provide signed informed consent

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
KBC Bežanijska kosa
Coordinator of this site? Confirm its status
BelgradeSerbiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.