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Recruiting NCT07378709

Exploratory Blood-Based Biomarkers in TACE-Treated Hepatocellular Carcinoma

— Observational Hepatocellular Carcinoma (HCC) Liver Neoplasms

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 →

Unsure about the terms? Read our patient guide →

Official title

Blood-Based Biomarkers for Prediction and Monitoring of Response to TACE in Hepatocellular Carcinoma: A Pilot Study

Overview

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.

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: NCT07378709 · 6249_pilot_study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗