Stereotactic Body Radiotherapy Versus Ablation for Perivascular Hepatocellular Carcinoma: A Phase 2, Multicenter, Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Sun Yat-sen University
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Disease-free survival
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
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.
Investigators
Ming Kuang
Vice President
First Affiliated Hospital, Sun Yat-Sen University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Disease-free survival
Time Frame: 2 years
The duration between radomization and recurrence, progression or death
1-year local recurrence rate
Time Frame: 1 year
The rate of participants who have recurrence in treating area in 1 year to all the participants
Secondary Outcomes
- Overall survival(2 years)
- 2-year recurrence rate(2 years)
- Adverse events(2 years)