At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 554 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 Blind, Dummy-Controlled Study of ThermoDox® (Lyso-Thermosensitive Liposomal Doxorubicin-LTLD) in Hepatocellular Carcinoma (HCC) Using Standardized Radiofrequency Ablation (RFA) Treatment Time ≥ 45 Minutes for Solitary Lesions ≥ 3 cm to ≤ 7 cm
In Brief
A Phase 3 clinical trial evaluating ThermoDox and Dummy infusion for Hepatocellular Carcinoma. Completed, enrolled 554 participants across 61 sites in 14 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 standardized radiofrequency ablation (sRFA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesCanada, China, Germany, Hong Kong, Italy, Malaysia, Philippines, Singapore, South Korea, Spain, Taiwan, Thailand, United States, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartJun 2014
Primary CompletionApr 2020
TodayJul 2026
First PostedApr 14, 2014
Enrollment StartJun 1, 2014
Primary CompletionApr 27, 2020
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 12.2 years ago
Interventions
ThermoDoxdrug
Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
Dummy infusiondrug
Sodium Chloride 0.9% or 5% Dextrose (D5W), Single 30 minute intravenous infusion