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S-1 + Calcium Folinate in Advanced Hepatocellular Carcinoma
NCT01533324Phase 2
Key facts
- Status
- Unknown
- Start
- Nov 2011
- Primary completion
- Nov 2016
- Countries
- 1
- Sponsor
- Naval Medical University
- Modality
- Small Molecules
- Drugs
- tegafur
- Conditions
- hepatocellular carcinoma (HCC)
01
Overview
Phase 2, open-label, single-arm trial of tegafur in hepatocellular carcinoma (HCC), sponsored by Naval Medical University. Primary endpoint: Durable Complete Response at 2 years. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
S-1 combined with LV
S-1 combined with Leucovorin
03
Who it enrols
Adults aged 18-70 with unresectable primary hepatocellular carcinoma, Child-Pugh A or B without ascites, ECOG 0, adequate organ function, and expected survival >= 12 weeks. Excludes patients with recent local treatment, heart disease, HIV, active infections, GI bleeding, recent thromboembolic events, or other malignancies.
04
Endpoints
Primary
Durable Complete Response
Secondary
Time to Progression
Overall Survival
Safety
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