Hepatocellular Carcinoma (HCC), Liver Neoplasms
Conditions
Keywords
Hepatocellular Carcinoma, TACE, Biomarkers, mRECIST, Drug-Eluting Beads
Brief summary
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.
Interventions
None listed
Sponsors
University of Belgrade
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between blood-based biomarkers and early radiological response | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiological Response Assessment via mRECIST. | 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. |
| Changes in Tumor Marker Levels (AFP and PIVKA-II). | 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. |
| Assessment of Liver Function Post-TACE. | 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). |
| Exploratory Serum Biomarker Profiling (Proteomics, miRNA, and Oxidative Stress). | 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). |
Countries
Serbia
Contacts
CONTACTMarko Stojanović, Medical Doctor
Outcome results
None listed