NCT01861912

Arsenic Trioxide TACE and Intravenous Administration in Unresectable Hepatocellular Carcinoma

Arsenic Trioxide TACE and Intravenous Administration Compared With Arsenic Trioxide TACE Alone in Unresectable Hepatocellular Carcinoma: a Randomized, Parallel, Controlled, Multi-center Clinical Study

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 258 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether compared with arsenic trioxide TACE alone, arsenic trioxide TACE and intravenous administration could further prolong the overall survival.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DEVICE	Arsenic trioxide TACE	Arsenic trioxide powder 20mg dissolved in lipiodol(the dosage of lipiodol is decided according to the volume of the target lesion)is used for transcatheter arterial chemoembolization(TACE). TACE will be repeated after 4\~6 weeks if it is necessary according to the assessment from imaging modalities
DRUG	Arsenic trioxide intravenous infusion	Arsenic trioxide intravenous infusion: arsenic trioxide powder 0.15mg/Kg/d(maxim 10mg/d) dissolved in 250ml 0.9%NaCl solution is used for intravenous infusion.Every course will last for 3 weeks and the next course will be continued after 1 week suspension.Intravenous infusion will be suspended 3 days before and 7\~14 days after TACE.
DRUG	lipiodol	Lipiodol is used to dissolve arsenic trioxide for TACE,with the dosage decided according to the volume of the target lesion.
DRUG	NaCl solution	250ml NaCl solution is used to dissolve the arsenic trioxide for intravenous infusion.

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-06-01
• Completion: 2016-12-01
• First posted: 2013-05-24
• Last updated: 2013-06-05