Blood biomarker changes before and after TACE for hepatocellular carcinoma
Blood-Based Biomarkers for Prediction and Monitoring of Response to TACE in Hepatocellular Carcinoma: A Pilot Study
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 |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Belgrade Academic / other |
| Locations | 1 site (Belgrade) |
| Trial ID | NCT07378709 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous observational studies of blood biomarkers in TACE-treated HCC have shown mixed but promising signals, so this approach is exploratory rather than established.
Eligibility criteria
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 this trial is running
Belgrade
- KBC Bežanijska kosa — Belgrade, Serbia (Recruiting)
Study contacts
- Study coordinator: Marko Stojanović, Medical Doctor
- Email: marko.stojanovic@med.bg.ac.rs
- Phone: 00381601435353
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.