NCT00843934

Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Nihon University · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of cisplatin (CDDP) and epirubicin (EPI) in the treatment of transcatheter chemoembolization for Hepatocellular Carcinoma (HCC).

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	epirubicin	Arm E: Suspension is prepared before arterial infusion as follows: Epirubicin is dissolved with water-soluble, non-ionized contrast medium then mixed with Lipiodol by pumping. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of EPI and Lipiodol are 60mg/m2 and 0.3mL/Kg, respectively.
DRUG	Cisplatin	Arm C: Suspension is prepared before arterial infusion as follows: Cisplatin (Water soluble CDDP: IA CALL) is mixed with Lipiodol. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of Cisplatin and Lipiodol are 65mg/m2 and 0.3mL/Kg, respectively.

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-12-01
• Completion: 2015-02-01
• First posted: 2009-02-13
• Last updated: 2012-10-19

Locations

1 site across 1 country: Japan