Validation of Blood-Based Biomarkers in TACE-Treated Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma (HCC), Liver Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Serbia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Blood-Based Biomarkers for Prediction and Monitoring of Response to TACE in Hepatocellular Carcinoma
Overview
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.
Primary outcome measures
- 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.]
Secondary outcome measures (4)
- 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).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Serbia · 1 center
- KBC Bežanijska kosa — Belgrade
Identifiers
NCT: NCT07414433 · 6249_main_study