Trials / Unknown
UnknownNCT01217034
Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib
Phase II Study: Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib (TACTICS)
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 228 (estimated)
- Sponsor
- Kindai University · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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
Conditions
- Hepatocellular Carcinoma
- Unresectable Hepatocellular Carcinoma
- Carcinoma, Hepatocellular
- Liver Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TACE with sorafenib | 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. |
| PROCEDURE | TACE alone | TACE will be conducted at scheduled day. When tumor increases, TACE will be repeated. |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2018-03-01
- Completion
- 2018-03-01
- First posted
- 2010-10-08
- Last updated
- 2017-10-31
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01217034. Inclusion in this directory is not an endorsement.