Exploratory Blood-Based Biomarkers in TACE-Treated Hepatocellular Carcinoma (BLOOD-TACE-P)

University of Belgrade

Status: Enrolling

Conditions: Liver Neoplasms; Hepatocellular Carcinoma (HCC)

Study type: Observational

Funder types: Other

Identifiers

NCT07378709

6249_pilot_study

Details and patient eligibility

About

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.

Enrollment: 15 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

15 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.