Blood biomarker changes before and after TACE for hepatocellular carcinoma
Official title: Blood-Based Biomarkers for Prediction and Monitoring of Response to TACE in Hepatocellular Carcinoma: A Pilot Study
Run by University of Belgrade · NCT07378709 · Data updated 2026-11-12
This will see if blood biomarkers change after TACE and whether those changes match early CT/MRI response in adults with hepatocellular carcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | University of Belgrade Academic / other |
| Locations | 1 site (Belgrade) |
| Status | Recruiting |
| Started | August 21, 2024 |
| Main results expected | June 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT07378709 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with HCC who are scheduled for standard-of-care TACE, have Child-Pugh scores ≤7, ECOG 0, no extrahepatic spread or macrovascular invasion, and can return for a 4–8 week follow-up CT/MRI are ideal candidates.
✕Probably not a fit
Patients with extrahepatic dissemination or macrovascular invasion, Child-Pugh ≥8, ECOG >0, inability to undergo TACE or follow-up imaging, pregnancy, or inability to consent are unlikely to benefit from this observational protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study of adults with hepatocellular carcinoma who are planned to receive standard-of-care transarterial chemoembolization (TACE). Participants give blood samples before their first TACE and at predefined follow-up visits on the day of a subsequent TACE or a control CT/MRI, and their tumors are evaluated using mRECIST criteria about 4–8 weeks after treatment. The study includes patients selected under usual clinical criteria (BCLC-guided TACE candidates, Child-Pugh score ≤7, ECOG 0) and excludes those with extrahepatic disease or macrovascular invasion. No investigational interventions are given; the protocol links biomarker changes to routine radiological and clinical outcomes.
Why it matters
Potential benefit: If successful, simple blood tests could give an early signal of how well TACE is working so clinicians can consider treatment adjustments sooner.
How similar studies have gone: Previous observational studies of blood biomarkers in TACE-treated HCC have shown mixed but promising signals, so this approach is exploratory rather than established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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KBC Bežanijska kosa
Belgrade, Serbia Recruiting
Study contacts
- Study coordinator: Marko Stojanović, Medical Doctor
- Email: marko.stojanovic@med.bg.ac.rs
- Phone: 00381601435353
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.