SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma (SAIL)

Sun Yat-sen University

Status: Enrolling

Conditions: Hepatocellular Carcinoma

Treatments: Radiation: Stereotactic Body Radiation Therapy; Procedure: radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04434989

HCC2020

Details and patient eligibility

About

This trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to explore the efficacy and safety of SBRT for perivascular hepatocellular carcinoma, compared with RFA.

Full description

The primary endpoint is 1-year local recurrence rate and disease-free survival. We planned to recruit 170 patients who diagnosed as perivascular hepatocellular carcinoma. The patients will be randomized into SBRT group and RFA group as 1:1 ratio.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma after curative treatment.
2. Unifocal tumor ≤5cm
3. Closed to great vessels (diameter ≥3mm)
4. ECOG score 0-1
5. Child-Pugh grade A or B7
6. Sufficient liver and kidney function

Exclusion criteria

1. Vascular invasion
2. Extra-hepatic metastasis
3. Received TACE before
4. Inflammation of local skin
5. Dysfunction of liver, kidney or bone marrow.
6. Concomitant other malignant tumor or HIV infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Stereotactic Body Radiation Therapy

Experimental group

Description:

SBRT is defined as a special radiotherapy technique. The high dose of radiotherapy is accurately injected into the tumor lesion in one to several times using external irradiation technique. Then the tumor is exposed to high dose and the surrounding normal tissue to low dose.

Treatment:

Radiation: Stereotactic Body Radiation Therapy

Radiofrequency Ablation

Active Comparator group

Description:

Percutaneous radiofrequency ablation to the tumor

Treatment:

Procedure: radiofrequency ablation