SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma

Stereotactic Body Radiotherapy Versus Ablation for Perivascular Hepatocellular Carcinoma: A Phase 2, Multicenter, Randomized Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04434989

Acronym

SAIL

Enrollment

170

Registered

2020-06-17

Start date

2020-06-01

Completion date

2025-12-01

Last updated

2020-06-17

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

Conditions

Hepatocellular Carcinoma

Brief summary

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.

Detailed 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.

Interventions

RADIATIONStereotactic Body Radiation Therapy

SBRT for perivascular HCC

PROCEDUREradiofrequency ablation

RFA for perivascular HCC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
1-year local recurrence rate	1 year	The rate of participants who have recurrence in treating area in 1 year to all the participants
Disease-free survival	2 years	The duration between radomization and recurrence, progression or death

Secondary

Measure	Time frame	Description
Overall survival	2 years	The duration between radomization and death
2-year recurrence rate	2 years	The rate of participants who have recurrence in 2 years to all the participants
Adverse events	2 years	The incidence rate of severe adverse events

Countries

China

Outcome results

None listed

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