Exploratory Blood-Based Biomarkers in TACE-Treated Hepatocellular Carcinoma (BLOOD-TACE-P)

February 2, 2026 updated by: Marko Stojanovic, University of Belgrade

Blood-Based Biomarkers for Prediction and Monitoring of Response to TACE in Hepatocellular Carcinoma: A Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

15

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

  • Serbia
      • Belgrade, Serbia
        • Recruiting
        • KBC Bežanijska kosa
        • Contact:

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
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.
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).
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.
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).

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 (Actual)

August 21, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6249_pilot_study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared to protect patient privacy and confidentiality, as the informed consent form signed by participants does not include a provision for the public sharing of raw individual data. Furthermore, as a pilot study, the primary focus is on generating preliminary evidence and internal hypothesis testing.

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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