ThinkRadial: A Prospective Study of Transradial deTACE in HCC Patients (ThinkRADIAL)

Asan Medical Center

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Transradial drug-eluting beadsTransarterial Chemoembolization (DEB-TACE)

Study type: Observational

Funder types: Other

Identifiers

NCT07160374

2017-1433

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

38 participants in 1 patient group

Transradial drug-eluting beadsTransarterial Chemoembolization (DEB-TACE) group

Description:

Patients with hepatocellular carcinoma (HCC) who undergo transarterial chemoembolization (TACE) using a transradial arterial approach with HepaSphere microspheres. Participants will be observed prospectively to evaluate the technical success, safety, and tumor response following treatment.

Treatment:

Procedure: Transradial drug-eluting beadsTransarterial Chemoembolization (DEB-TACE)