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Low-Dose Thalidomide Adjuvant Therapy After RFA for HCC
NCT00728078Phase 3
Key facts
- Status
- Unknown
- Start
- Jul 2008
- Primary completion
- Jul 2009
- Countries
- 1
- Sponsor
- Sun Yat-sen University
- Modality
- Small Molecules
- Drugs
- thalidomide
- Conditions
- hepatocellular carcinoma (HCC)
01
Overview
Phase 3, randomised, open-label trial of thalidomide in hepatocellular carcinoma (HCC) (2 arms), sponsored by Sun Yat-sen University. Primary endpoints: Progression-Free Survival at 5 years and Morbidity at 1 month. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Thalidomide
Thalidomide 50mg tid for 6 months
Control
No intervention
03
Who it enrols
Patients aged 18-75 with solitary HCC 3.1-7.0cm or 2-3 lesions <= 7.0cm visible on US, who refused surgery or have first recurrence after hepatectomy. Must have platelet count > 40,000/mm3 and no extrahepatic metastasis or portal vein invasion.
04
Endpoints
Primary
Progression-Free Survival
Morbidity
Secondary
Overall Survival
Recurrence Rate
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