An observational study in Hepatocellular Carcinoma (HCC) and Liver Neoplasms, sponsored by University of Belgrade. Recruiting at 1 site in Serbia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by University of Belgrade · Observational
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.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 15 is below the median of 200 across 850 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →University of Belgrade is the lead sponsor of 72 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with hepatocellular carcinoma (HCC) treated with transarterial chemoembolization (TACE) at the University Hospital Center (KBC) Bežanijska kosa
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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).
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.
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).
Plan to share: No — 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.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Belgrade