ThinkRadial: A Prospective Study of Transradial deTACE in HCC Patients

Completed

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT07160374
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study Start: 2018-08-21
• Primary Completion: 2023-02-03
• Status Verified: 2025-08
• Study Completion: 2025-08-04
• Study First Submitted: 2025-08-29
• Study First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

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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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, South Korea