Hepatocellular CarcinomaThinkRADIALNCT07160374
ThinkRadial: A Prospective Study of Transradial deTACE in HCC Patients
An observational study of Hepatocellular Carcinoma, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Transradial drug-eluting beadsTransarterial Chemoembolization (DEB-TACE)
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Aug 2018to 4 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hepatocellular carcinoma treated at Asan Medical Center, Seoul, Korea.
Who may be able to join
- -
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Transarterial Drug-Eluting Chemoembolization for HCC Patients in Korea Using Transradial Approach
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Transradial drug-eluting beadsTransarterial Chemoembolization (DEB-TACE)
- Keywords
- Transarterial Chemoembolization, Drug-Eluting Beads, Transradial Access, HepaSphere, mRECIST
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transradial drug-eluting beadsTransarterial Chemoembolization (DEB-TACE)Procedure or surgery
Transarterial chemoembolization performed through the radial artery using HepaSphere drug-eluting microspheres in patients with hepatocellular carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Transradial drug-eluting beadsTransarterial Chemoembolization (DEB-TACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success Rate
Defined as successful completion of the planned transarterial chemoembolization (TACE) procedure using transradial access without conversion to transfemoral access.
Measured: Immediately after the procedure
Secondary outcomes (2)
Tumor Response Rate Based on mRECIST
Assessed using modified RECIST (mRECIST) criteria by imaging studies. Includes complete response, partial response, stable disease, or progressive disease.
Measured: 1-3 months post-treatment
Incidence of Adverse Events
Number and type of adverse events observed following the TACE procedure. Severity will be graded using CTCAE criteria.
Measured: Within 30 days of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start21 Aug 2018
- Primary completion3 Feb 2023
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihoon Kim, Asan Medical Center
- Investigators
- Ji Hoon Shin, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160374
- Sponsor's protocol ID
- 2017-1433
- Acronym
- ThinkRADIAL
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The shared IPD will include anonymized clinical and laboratory results collected during the trial
Publications
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.
PubMed 26070616
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transarterial Drug-Eluting Chemoembolization for HCC Patients in Korea Using Transradial Approach
- ClinicalTrials.gov ID
- NCT07160374
- Acronym / sponsor ID
- ThinkRADIAL / 2017-1433
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Transarterial Chemoembolization, Drug-Eluting Beads, Transradial Access, HepaSphere, mRECIST
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transradial drug-eluting beadsTransarterial Chemoembolization (DEB-TACE) group | – | Procedure: Transradial drug-eluting beadsTransarterial Chemoembolization (DEB-TACE)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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatocellular carcinoma treated at Asan Medical Center, Seoul, Korea.
Key inclusion criteria (7 listed)
- -
- Age between 19 and 80 years
- Diagnosed with hepatocellular carcinoma (HCC)
- Child-Pugh class A
- ECOG performance status 0 or 1
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transradial drug-eluting beadsTransarterial Chemoembolization (DEB-TACE)Transarterial chemoembolization performed through the radial artery using HepaSphere drug-eluting microspheres in patients with hepatocellular carcinoma. | Procedure or surgery | Transradial drug-eluting beadsTransarterial Chemoembolization (DEB-TACE) group |
Primary outcome
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.
2 secondary outcomes
Tumor Response Rate Based on mRECIST
Time frame: 1-3 months post-treatment
Incidence of Adverse Events
Time frame: Within 30 days of procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 26070616Fischman 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.
- Individual participant dataSharing planned: Yes. The shared IPD will include anonymized clinical and laboratory results collected during the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Hoon Shin, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success Rate (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07160374, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.