Actively Recruiting

Age: 18Years +
All Genders
ID07378709

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

Led by University of Belgrade · Updated on 2026-02-05

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This observational study focuses on adult patients with hepatocellular carcinoma (HCC) who are candidates for Transarterial Chemoembolization (TACE) treatment. It aims to evaluate changes in selected blood-based biomarkers and their potential relationship with early radiological treatment outcomes measured by the Modified Response Evaluation Criteria in Solid Tumors (mRECIST). The study explores whether biomarker changes correlate with the success of TACE as part of standard care for HCC patients with preserved liver function and good performance status. Participants will receive standard-of-care TACE as determined by their medical team. Blood samples will be collected before the first TACE procedure and during follow-up visits on the day of subsequent TACE treatments or control CT scans. Routine clinical and radiological evaluations, including multiphase CT or MRI scans, will be performed four to eight weeks after each procedure to monitor tumor response and liver function. During the study, researchers will collect data from medical records and diagnostic tests. They will assess biomarker changes, tumor marker levels, radiological response, and liver function over time. The primary outcome is the correlation between blood biomarkers and early radiological response within 4-8 weeks post-TACE. The study provides ongoing monitoring through follow-up imaging and blood tests, with participant involvement lasting through these assessment periods.

CONDITIONS

Brief Title

Exploratory Blood-Based Biomarkers in TACE-Treated Hepatocellular Carcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of hepatocellular carcinoma (HCC) based on LI-RADS CT/MRI v2018 criteria or histopathological confirmation
  • Candidate for Transarterial Chemoembolization (TACE) as part of standard treatment following BCLC criteria
  • Child-Pugh liver function score of 7 or less at time of TACE indication
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 at time of TACE indication
  • Availability of at least one follow-up multiphase CT or MRI scan 4-8 weeks after TACE
Not Eligible

You will not qualify if you...

  • Child-Pugh liver function score of 8 or higher at time of TACE indication
  • Eastern Cooperative Oncology Group (ECOG) performance status greater than 0 at time of TACE indication
  • Presence of extrahepatic disease spread or macrovascular invasion
  • Technically unfeasible TACE procedure (e.g., inability to identify feeder artery)
  • Severe uncorrectable blood clotting problems or low blood cell counts
  • Severe allergy or contraindication to iodine contrast agents or drugs used during TACE
  • Pregnancy or breastfeeding
  • Inability to provide signed informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - From baseline (before first TACE) up to 8 weeks after the final TACE procedure

Participants who undergo transarterial chemoembolization (TACE) as part of their standard clinical care are observed to collect blood-based biomarkers and assess liver function and tumor response.

1 baseline visit before TACE and follow-up visits 4 to 8 weeks after each TACE procedure

Trial Site Locations

Total: 1 location

1

KBC Bežanijska kosa

Belgrade, Serbia

Actively Recruiting

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Research Team

M

Marko Stojanović, Medical Doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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