A Prospective Observational Study on Efficacy of TARE for... | NCT07278102

Studies
A Prospective Observational Study on Efficacy of TARE for Early Stage HCC

NCT07278102

Sponsor

Seoul National University Hospital

Status

Active, not recruiting

Last Update Posted

Dec 11, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Radioembolization
Hepatocellular Carcinoma (HCC)
Early Stage

Interventions

transarterial radioembolization

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 28, 2022Actual

Primary Completion Date

Jan 31, 2026Estimated

Completion Date

May 31, 2026Estimated

First Submitted Date

Nov 29, 2025

First Submission Date that Met QC Criteria

Nov 29, 2025

First Posted Date

Dec 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2025

Last Update Posted Date

Dec 11, 2025Actual

Name	Class
National Cancer Center, Korea	OTHER_GOV
Severance Hospital	OTHER
Samsung Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the current study is to analyze treatment outcomes (best target lesion response, overall survival, time to target lesion progression, time to overall progression, and treatment-related adverse event) using prospectively collected clinical and imaging data in patients with BCLC 0 or A HCCs treated with TheraSphere® in four large-volume hospitals from Korea. The results will pave the way for expanding 90Y-TARE indication and refining reimbursement guidelines, and provide baseline data for possible subsequent future studies.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
TARE		early stage hepatocellular carcinoma	Procedure: transarterial radioembolization

Name	Type	Description	Arm Group Labels	Other Names
transarterial radioembolization	Procedure	TARE with 90Y	TARE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	Overall survival	From enrollment to the end of treatment at 3 years
best target lesion response	best target lesion response	"From enrollment to the end of treatment at 3 years

Secondary Outcomes

Measure	Description	Time Frame
Time to target lesion progression	Time to target lesion progression	From enrollment to the end of treatment at 3 years
Time to overall progression	Time to overall progression

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A. Patients receiving TARE using TheraSphere® B. Treatment naïve BCLC 0 or A single HCC up to 8 cm (diagnosed according to diagnostic criteria of KLCA-NCC) C. Tumor involvement < 50% of total liver volume based on dynamic CT or MRI D. Age > or = 18 E. ECOG performance status 0 F. AST/ALT < or = 5 times the upper limits of normal G. A life expectancy > 3 months H. Non-pregnant with an acceptable contraception in premenopausal women I. Ability to provide written informed consent and to comply with all study conditions

Exclusion Criteria:

A. Contraindications to angiography and selective catheterization B. Known anaphylaxis to iodinated contrast C. Expected lung dose > 30Gy per a session D. Unable to avoid non-target 90Y flow into the extrahepatic organs except the lungs E. Decompensated liver cirrhosis (Child-Pugh score > 7) F. Active uncontrolled infection G. Pregnancy H. Current or history (< or = 5 years) of malignancies in the other organs I. History of liver transplantation J. Any vascular invasion

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients receiving TARE using TheraSphere® Treatment naïve BCLC 0 or A single HCC up to 8 cm (diagnosed according to diagnostic criteria of KLCA-NCC) Tumor involvement < 50% of total liver volume based on dynamic CT or MRI Age > or = 18 ECOG performance status 0 AST/ALT < or = 5 times the upper limits of normal A life expectancy > 3 months Non-pregnant with an acceptable contraception in premenopausal women Ability to provide written informed consent and to comply with all study conditions

Sampling Method

Non-Probability Sample

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type