Validation of Blood-Based Biomarkers in TACE-Treated Hepatocellular Carcinoma (BLOOD-TACE-M)

University of Belgrade

Status: Not yet enrolling

Conditions: Liver Neoplasms; Hepatocellular Carcinoma (HCC)

Study type: Observational

Funder types: Other

Identifiers

NCT07414433

6249_main_study

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

HCC Patients Treated With TACE

Description:

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.