Hepatocellular Carcinoma
Conditions
Keywords
Transarterial Chemoembolization, Drug-Eluting Beads, Transradial Access, HepaSphere, mRECIST
Brief summary
This study is a prospective, observational clinical trial designed to evaluate the feasibility, safety, and effectiveness of performing transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) using a transradial arterial approach. Traditionally, TACE procedures are performed through the femoral artery in the groin, but using the radial artery in the wrist may reduce complications, improve patient comfort, and allow for faster recovery. In this study, eligible patients with unresectable HCC who meet the inclusion criteria-such as preserved liver function (Child-Pugh A), good performance status, and tumors of a certain size and number-will undergo TACE using HepaSphere drug-eluting embolic materials via radial access. No randomization or drug intervention will be assigned by protocol, as the treatment will follow standard clinical practice. The study will follow participants for 12 months to assess technical success, tumor response using imaging criteria (mRECIST), safety outcomes including adverse events, and overall survival. The study is being conducted at Asan Medical Center in Seoul, Korea, and has received Institutional Review Board approval.
Detailed description
This is a prospective observational study to evaluate the feasibility, safety, and tumor response of transarterial chemoembolization (TACE) using a transradial approach in patients with hepatocellular carcinoma (HCC). Eligible patients will undergo drug-eluting beads TACE via radial access and be followed for up to 12 months. The primary outcome is the technical success rate of the procedure. Secondary outcomes include survival rate, tumor response by mRECIST, and adverse events.
Interventions
PROCEDURETransradial drug-eluting beadsTransarterial Chemoembolization (DEB-TACE)
Transarterial chemoembolization performed through the radial artery using HepaSphere drug-eluting microspheres in patients with hepatocellular carcinoma.
Sponsors
Asan Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Inclusion Criteria: * Age between 19 and 80 years * Diagnosed with hepatocellular carcinoma (HCC) * Child-Pugh class A * ECOG performance status 0 or 1 * Tumor size between 3 and 10 cm, with 1 to 7 nodules * Ability to provide written informed consent
Exclusion criteria
* Child-Pugh class B or C * Presence of other malignancies * CKD stage 4 or 5 (eGFR \< 30 mL/min/1.73m²) * Known allergy or contraindication to contrast media * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success Rate | Immediately after the procedure | Defined as successful completion of the planned transarterial chemoembolization (TACE) procedure using transradial access without conversion to transfemoral access. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response Rate Based on mRECIST | 1-3 months post-treatment | Assessed using modified RECIST (mRECIST) criteria by imaging studies. Includes complete response, partial response, stable disease, or progressive disease. |
| Incidence of Adverse Events | Within 30 days of procedure | Number and type of adverse events observed following the TACE procedure. Severity will be graded using CTCAE criteria. |
Countries
South Korea
Outcome results
None listed