SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Radiation: Stereotactic Body Radiation Therapy
* Procedure: radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma after curative treatment. Unifocal tumor ≤5cm Closed to great vessels (diameter ≥3mm) ECOG score 0-1 Child-Pugh grade A or B7 Sufficient liver and kidney function Exclusion Criteria: Vascular invasion Extra-hepatic metastasis Received TACE before Inflammation of local skin Dysfunction of liver, kidney or bone marrow. Concomitant other malignant tumor or HIV infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotactic Body Radiation Therapy<br>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. | Radiation: Stereotactic Body Radiation Therapy<br>* SBRT for perivascular HCC<br>* Other names: SBRT;|
| Active Comparator: Radiofrequency Ablation<br>Percutaneous radiofrequency ablation to the tumor | Procedure: radiofrequency ablation<br>* RFA for perivascular HCC<br>* Other names: RFA;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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