Comparison of SBRTand Repeat TACE for HCC (STH)

Gangneung Asan Hospital

Status: Unknown

Conditions: HepatoCellular Carcinoma

Treatments: Radiation: SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT03326375

GNH_RT-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

SBRT (Stereotatic body radiotherapy)

Experimental group

Description:

Treatment of SBRT in HCC patients who have incomplete response after first TACE

Treatment:

Radiation: SBRT

TACE (Transarterial chemoembolization)

No Intervention group

Description:

Treatment of repeated TACE in HCC patients who have incomplete response after first TACE