Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Sorafenib plus Tegafur-uracil in Advanced HCC
NCT01539018Phase 2
Key facts
- Status
- Terminated
- Start
- Jan 2012
- Primary completion
- Jan 2015
- Countries
- 1
- Sponsor
- Egyptian Society of Liver Cancer
- Modality
- Small Molecules
- Drugs
- tegafur + uracil
- Conditions
- hepatocellular carcinoma (HCC)
01
Overview
Phase 2, randomised, open-label trial of tegafur + uracil in hepatocellular carcinoma (HCC), sponsored by Egyptian Society of Liver Cancer. Started Jan 2012; status: terminated.
02
Design
- Study design
- RandomizedOpen-label
03
Who it enrols
Adults with advanced, unresectable HCC not eligible for local ablation or TACE, with Child-Pugh A or B7 status and ECOG 0-2, who have not received prior systemic therapy.
04
Registry description
- Unlike the Asian and western regions, The vast majority of the Egyptian/Arabic Hepatocellular Carcinoma (HCC) patients are hepatitis C virus (HCV) associated.
- According to the SHARP study subgroup analysis, it seems that HCV associated HCC patients derive the max benefit of Sorafenib, the absolute gain between the Sorafenib arm \& the placebo in m OS = 7 months, HR=0.58 (95% CI: 0.37-0.91).
- In spite of improvement in terms of overall survival (OS) and time to progression (TTP), in all studies where Sorafenib was compared to placebo, the Sorafenib arm was not accompanied by a…
Beyond the preview
Go deeper on NCT01539018.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT01539018.