SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma

• 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

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