SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Radiation: Stereotactic Body Radiation Therapy; Procedure: radiofrequency ablation

• Registration Number: NCT04434989
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Status Verified: 2020-06
• Study Start: 2020-06-01
• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-15
• Last Update Submitted: 2020-06-15
• Study First Posted: 2020-06-17
• Last Update Posted: 2020-06-17
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stereotactic Body Radiation Therapy	Stereotactic Body Radiation Therapy	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.
Radiofrequency Ablation	radiofrequency ablation	Percutaneous radiofrequency ablation to the tumor

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China