Status:
UNKNOWN
SBRT Versus Ablation for Perivascular Hepatocellular Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
NA
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 randomiz...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04434989
Start Date
June 1 2020
End Date
December 1 2025
Last Update
June 17 2020
Active Locations (1)
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1
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080