Validation of Blood-Based Biomarkers in TACE-Treated Hepatocellular Carcinoma

Blood-Based Biomarkers for Prediction and Monitoring of Response to TACE in Hepatocellular Carcinoma

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.

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