Comparison of SBRTand Repeat TACE for HCC

Comparison of Stereotactic Body Radiation Therapy (SBRT)and Repeat Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma (HCC) as a Local Salvage Treatment After Incomplete TACE : A Prospective Randomized Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03326375

Acronym

STH

Enrollment

Registered

2017-10-31

Start date

2017-03-01

Completion date

2021-03-31

Last updated

2017-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HepatoCellular Carcinoma

Keywords

TACE, SBRT

Brief summary

Comparison of Stereotactic Body Radiation Therapy (SBRT) and repeated transarterial chemoembolization (TACE) for Hepatocellular Carcinoma (HCC)as a Local Salvage Treatment after first incomplete TACE

Detailed description

The aim of this study is to evaluate the effect of SBRT after first incomplete TACE. In HCC patients with incomplete TACE response, repeated TACE did not showed good response. In this case, SBRT could have better results than TACE.

Interventions

RADIATIONSBRT

Maximum dose : 60Gray (Gy) Fraction : 2 to 5

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

open labled

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Age \>18 years * Eastern cooperative oncology group(ECOG) score 0 to 2 * Primary HCC * HCC (single nodule ≤ 7 cm or max 3 nodules ≤ 3 cm) * Child-Turgottei-Pugh A or B * Unresectable lesion or medically contraindicated surgery or a case in which surgery was declined. * No evidence of radiologically definable major vascular invasion or extrahepatic disease * Previously incomplete TACE with radiologically defined residual disease after first TACE * Informed consent

Exclusion criteria

* Prior TACE to the target lesion * Contraindication to receiving radiotherapy or TACE * Decompensated liver cirrhosis * Extrahepatic mets * Pregnancy * Patients with other cancers

Design outcomes

Primary

Measure	Time frame	Description
Local tumor control (efficacy fo SBRT)	1 year	To evaluate the effect of SBRT. Local tumor control is defined as the disappearance of any intraarterial enhancement in all target lesions. Local tumor control will be measured on triphasic Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI). Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months.

Secondary

Measure	Time frame	Description
progression free-survival	2 year	survival from SBRT to recurrence
overall survival	2 year	survival from SBRT to death
Radiation induced liver disease (RILD)	1 year	Liver toxicities were evaluated using Common Terminology Criteria of Adverse Events (CTCAE). RILD was defined as elevated liver transaminases more than five times the upper normal limit or a worsening of Child-Pugh (CP) score by 2 within 3 months after SBRT.

Countries

South Korea

Contacts

Primary ContactBaek Gyu Jun, M.D

backyou78@hanmail.net+82-10-5764-0712

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026