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

NCT07414433 | Not Yet Recruiting

• 1 other identifier: 6249_main_study
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma (HCC); Liver Neoplasms

Keywords

Hepatocellular Carcinoma; TACE; Biomarkers; mRECIST; Drug-Eluting Beads

Outcome Measures

Primary Outcomes (1)

• Correlation between blood-based biomarkers and early radiological response

  Evaluation of changes in selected biomarkers (including AFP and PIVKA-II) and their potential association with early radiological outcomes following TACE, assessed using mRECIST criteria (Complete Response, Partial Response, Stable Disease, or Progressive Disease).

  From baseline (before first TACE) up to the follow-up assessment 4-8 weeks after the procedure.

Secondary Outcomes (4)

• Radiological Response Assessment via mRECIST.

  4-8 weeks after each TACE procedure.

• Changes in Tumor Marker Levels (AFP and PIVKA-II).

  Baseline (Day 0, before first TACE) and at each follow-up cycle (4-8 weeks after procedure).

• Assessment of Liver Function Post-TACE.

  From baseline up to 8 weeks after the final TACE procedure.

• Exploratory Serum Biomarker Profiling (Proteomics, miRNA, and Oxidative Stress).

  From baseline (Day 0, before first TACE) up to the first follow-up assessment (4-8 weeks post-procedure).

Study Arms (1)

HCC Patients Treated With TACE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatocellular carcinoma (HCC) treated with transarterial chemoembolization (TACE) at the University Hospital Center (KBC) "Bežanijska kosa"

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

KBC Bežanijska kosa

Belgrade, Serbia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood (serum and plasma)

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Marko Stojanović, Medical Doctor

CONTACT

+381601435353; marko.stojanovic@med.bg.ac.rs

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Pharmacology, Clinical Pharmacology and Toxicology

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)