ThinkRadial: A Prospective Study of Transradial deTACE in HCC Patients

NCT07160374 | Completed

• 1 other identifier: 2017-1433
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Transarterial Chemoembolization; Drug-Eluting Beads; Transradial Access; HepaSphere; mRECIST

Outcome Measures

Primary Outcomes (1)

• Technical Success Rate

  Defined as successful completion of the planned transarterial chemoembolization (TACE) procedure using transradial access without conversion to transfemoral access.

  Immediately after the procedure

Secondary Outcomes (2)

• Tumor Response Rate Based on mRECIST

  1-3 months post-treatment

• Incidence of Adverse Events

  Within 30 days of procedure

Study Arms (1)

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

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.

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

Interventions

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

Transarterial chemoembolization performed through the radial artery using HepaSphere drug-eluting microspheres in patients with hepatocellular carcinoma.

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatocellular carcinoma treated at Asan Medical Center, Seoul, Korea.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

Related Publications (1)

• Fischman AM, Swinburne NC, Patel RS. A Technical Guide Describing the Use of Transradial Access Technique for Endovascular Interventions. Tech Vasc Interv Radiol. 2015 Jun;18(2):58-65. doi: 10.1053/j.tvir.2015.04.002. Epub 2015 Apr 11.

  PMID: 26070616 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Ji Hoon Shin, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Radiology

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: August 21, 2018
• Primary Completion: February 3, 2023
• Study Completion: August 4, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)