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Nucleoid Antiviral Therapy After RFA for HCC
NCT00555334Phase 4
Key facts
- Status
- Unknown
- Start
- Nov 2007
- Primary completion
- Dec 2009
- Countries
- 1
- Sponsor
- Sun Yat-sen University
- Modality
- Small Molecules
- Drugs
- lamivudineentecavir
- Conditions
- hepatocellular carcinoma (HCC)
01
Overview
Phase 4, randomised, single-blind trial of lamivudine and entecavir in hepatocellular carcinoma (HCC) (2 arms), sponsored by Sun Yat-sen University. Primary endpoint: Overall Survival at 5 years. Status: unknown.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Nucleoid antiviral therapy
RFA followed by lamivudine (100mg qd) or entecavir (0.5mg qd)
RFA only
RFA followed by observation
03
Who it enrols
Patients aged 18-75 with solitary HCC <= 7.0cm or multiple HCC <= 3 lesions each <= 3.0cm, visible on US, with no extrahepatic metastasis or vascular invasion. Excludes patients with severe cardiac disease, HIV, or other active cancers.
04
Endpoints
Primary
Overall Survival
Secondary
Recurrence Rates
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