Validation of Blood-Based Biomarkers in TACE-Treated Hepatocellular Carcinoma (BLOOD-TACE-M)

February 9, 2026 updated by: Marko Stojanovic, University of Belgrade

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with hepatocellular carcinoma (HCC) treated with transarterial chemoembolization (TACE) at the University Hospital Center (KBC) "Bežanijska kosa"

Description

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HCC Patients Treated With TACE
Patients with hepatocellular carcinoma (HCC) who are candidates for transarterial chemoembolization (TACE) as part of their standard clinical care. This group includes adult patients with preserved liver function (Child-Pugh ≤ 7) and good performance status Eastern Cooperative Oncology Group (ECOG) 0.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between blood-based biomarkers and early radiological response
Time Frame: From baseline (before first TACE) up to the follow-up assessment 4-8 weeks after the procedure.
Evaluation of changes in selected biomarkers (including AFP and PIVKA-II) and their potential association with early radiological outcomes following TACE, assessed using mRECIST criteria (Complete Response, Partial Response, Stable Disease, or Progressive Disease).
From baseline (before first TACE) up to the follow-up assessment 4-8 weeks after the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Tumor Marker Levels (AFP and PIVKA-II).
Time Frame: Baseline (Day 0, before first TACE) and at each follow-up cycle (4-8 weeks after procedure).
Measurement of the change in serum levels of Alpha-fetoprotein (AFP) and Protein Induced by Vitamin K Absence (PIVKA-II from baseline to follow-up points.
Baseline (Day 0, before first TACE) and at each follow-up cycle (4-8 weeks after procedure).
Exploratory Serum Biomarker Profiling (Proteomics, miRNA, and Oxidative Stress).
Time Frame: From baseline (Day 0, before first TACE) up to the first follow-up assessment (4-8 weeks post-procedure).
An exploratory evaluation of serum samples to identify changes in protein profiles (proteomics), circulating microRNA (miRNA) signatures, and markers of oxidative stress (e.g., Malondialdehyde, Superoxide Dismutase) as potential predictors or indicators of radiological response to Drug-eluting Bead Trans arterial Chemoembolization (DEB-TACE).
From baseline (Day 0, before first TACE) up to the first follow-up assessment (4-8 weeks post-procedure).
Radiological Response Assessment via mRECIST.
Time Frame: 4-8 weeks after each TACE procedure.
Tumor response will be evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST), a categorical scale used to assess viable tumor based on arterial enhancement on CT or MRI scans. Scale Information: Scale Type: Categorical Minimum Value: Complete Response (CR) - best outcome Maximum Value: Progressive Disease (PD) - worst outcome Directionality: Higher category represents a worse outcome Categories: Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) Outcome Reporting: The percentage of patients achieving each response category (CR, PR, SD, PD) will be reported.
4-8 weeks after each TACE procedure.
Assessment of Liver Function Post-TACE.
Time Frame: From baseline up to 8 weeks after the final TACE procedure.
Liver function will be monitored using the Child-Pugh Liver Function Score, which evaluates hepatic reserve based on five clinical and laboratory parameters (bilirubin, albumin, INR/prothrombin time, ascites, and hepatic encephalopathy). The score is calculated at baseline and during follow-up assessments to evaluate potential liver function deterioration after TACE. Scale Information: Full Scale Name: Child-Pugh Liver Function Score Scale Type: Ordinal numeric scale with clinical class categories Minimum Value: 5 points - best liver function (Child-Pugh Class A) Maximum Value: 15 points - worst liver function (Child-Pugh Class C) Directionality: Higher scores represent a worse clinical outcome Score Ranges / Classes: 5-6 points: Child-Pugh A (well-compensated liver disease) 7-9 points: Child-Pugh B (significant functional impairment) 10-15 points: Child-Pugh C (severe hepatic dysfunction).
From baseline up to 8 weeks after the final TACE procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Belgrade

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 30, 2029

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6249_main_study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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