At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 701 enrolled
Drug / intervention
ThermoDox +1 moredrug
Likely dose
ThermoDox 50 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Double-Blinded, Dummy-Controlled Study of the Efficacy and Safety of ThermoDox® (Thermally Sensitive Liposomal Doxorubicin) in Combination With Radiofrequency Ablation (RFA) Compared to RFA-Alone in the Treatment of Non-Resectable Hepatocellular Carcinoma
In Brief
A Phase 3 clinical trial evaluating ThermoDox and 5% Dextrose Solution for Hepatocellular Carcinoma. Completed, enrolled 701 participants across 79 sites in 11 countries.
Detailed Summary
The purpose of this study is to determine whether ThermoDox, a thermally sensitive liposomal doxorubicin, is effective in the treatment of non-resectable hepatocellular carcinoma when used in conjunction with radiofrequency ablation (RFA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesCanada, China, Hong Kong, Italy, Japan, Malaysia, Philippines, South Korea, Taiwan, Thailand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2008
Enrollment StartMay 2008
Primary CompletionJan 2013
Study CompletionAug 2016
TodayJul 2026
First PostedFeb 18, 2008
Enrollment StartMay 1, 2008
Primary CompletionJan 1, 2013
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 18.4 years ago
Interventions
ThermoDoxdrug
Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
5% Dextrose Solutiondrug
Single 30 minute intravenous infusion