Hepatocellular Carcinoma (HCC)BLOOD-TACE-PNCT07378709
Exploratory Blood-Based Biomarkers in TACE-Treated Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma (HCC) and Liver Neoplasms, run by University of Belgrade at 1 site in Serbia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Liver Neoplasms
- How many people
- 15 participants
- Where
- 1 siteSerbia
- Study dates
- 21 Aug 2024to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hepatocellular carcinoma (HCC) treated with transarterial chemoembolization (TACE) at the University Hospital Center (KBC) Bežanijska kosa
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Serbia1 site, 1 recruiting
- Recruiting
KBC Bežanijska kosa
Belgrade
Jovana Popović, Medical Doctor, 0038162214194, jovana.lalatovic@gmail.com
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma (HCC), Liver Neoplasms
- Keywords
- Hepatocellular Carcinoma, TACE, Biomarkers, mRECIST, Drug-Eluting Beads
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline (before first TACE) up to the follow-up assessment 4-8 weeks after the procedure.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: From baseline (Day 0, before first TACE) up to the first follow-up assessment (4-8 weeks post-procedure).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start21 Aug 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marko Stojanovic, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378709
- Sponsor's protocol ID
- 6249_pilot_study
- Acronym
- BLOOD-TACE-P
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood-Based Biomarkers for Prediction and Monitoring of Response to TACE in Hepatocellular Carcinoma: A Pilot Study
- ClinicalTrials.gov ID
- NCT07378709
- Acronym / sponsor ID
- BLOOD-TACE-P / 6249_pilot_study
- Conditions
- Hepatocellular Carcinoma (HCC), Liver Neoplasms
- Keywords
- Hepatocellular Carcinoma, TACE, Biomarkers, mRECIST, Drug-Eluting Beads
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatocellular carcinoma (HCC) treated with transarterial chemoembolization (TACE) at the University Hospital Center (KBC) Bežanijska kosa
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
4 secondary outcomes
Radiological Response Assessment via mRECIST.
Time frame: 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).
Assessment of Liver Function Post-TACE.
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC) and Liver Neoplasms, run by University of Belgrade at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marko Stojanović, Medical Doctor (00381601435353, marko.stojanovic@med.bg.ac.rs), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.