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NCT Number: NCT07160374

ThinkRadial: A Prospective Study of Transradial deTACE in HCC Patients

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Technical Success Rate

    Time frame: Immediately after the procedure

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

Secondary outcomes

  1. Tumor Response Rate Based on mRECIST

    Time frame: 1-3 months post-treatment

    Assessed using modified RECIST (mRECIST) criteria by imaging studies. Includes complete response, partial response, stable disease, or progressive disease.

  2. Incidence of Adverse Events

    Time frame: Within 30 days of procedure

    Number and type of adverse events observed following the TACE procedure. Severity will be graded using CTCAE criteria.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Transarterial Drug-Eluting Chemoembolization for HCC Patients in Korea Using Transradial Approach

Acronym: ThinkRADIAL

Important dates

Study start
2018
Primary completion
2023
Study completion
2025
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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