Hepatocellular Carcinoma Clinical Trial
Official title:
Phase II Study: Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib (TACTICS)
The purpose of this study is to evaluate the safety and efficacy of the combination therapy with Transcatheter Arterial Chemoembolization (TACE) and sorafenib compared to TACE alone in patients with unresectable hepatocellular carcinoma (HCC) who are not candidates for surgical resection or percutaneous ablation therapy.
TACE with sorafenib Group
Sorafenib will be administrated at a dose of 400mg o.d. before the first TACE. After 2days
drug rest, TACE will be conducted. Sorafenib will be resumed at a dose of 400mg o.d. from 3
days after TACE(the resumption day can be postponed until 21 days after TACE). When
tolerability is confirmed at 1 week after resumption, the dose of sorafenib will be increased
to 400mg b.i.d. When tumor increases, TACE will be repeated.
Control group
TACE will be conducted at scheduled day. When tumor increases, TACE will be repeated.
The treatment regimen will be continued until untreatable progression which is defined as
follows:
- Child-Pugh grade C
- Tumor growth (125 percent from baseline status)
- Vascular invasion(Vp3,Vp4)
- Extra hepatic spread which size is more than 10mm
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