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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with hepatocellular carcinoma (HCC) treated with transarterial chemoembolization (TACE) at the University Hospital Center (KBC) "Bežanijska kosa"
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 1 trial groupGroup A: HCC Patients Treated With TACE
Trial outcomes
Primary outcomes
1
Correlation between blood-based biomarkers and early radiological response
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).
Time frame
From baseline (before first TACE) up to the follow-up assessment 4-8 weeks after the procedure.Secondary outcomes
1
Radiological Response Assessment via mRECIST.
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.
Time frame
4-8 weeks after each TACE procedure.2
Changes in Tumor Marker Levels (AFP and PIVKA-II).
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.
Time frame
Baseline (Day 0, before first TACE) and at each follow-up cycle (4-8 weeks after procedure).3
Assessment of Liver Function Post-TACE.
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).
Time frame
From baseline up to 8 weeks after the final TACE procedure.4
Exploratory Serum Biomarker Profiling (Proteomics, miRNA, and Oxidative Stress).
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).
Time frame
From baseline (Day 0, before first TACE) up to the first follow-up assessment (4-8 weeks post-procedure).Sponsors and contacts
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Source ClinicalTrials.gov
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