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
Phase of Trial: Phase III
Latest Information Update: 27 Apr 2017
At a glance
- Drugs Doxorubicin liposomal (Primary)
- Indications Liver cancer
- Focus Registrational; Therapeutic Use
- Acronyms HEAT
- Sponsors Celsion Corporation
- 03 Feb 2017 Status changed from active, no longer recruiting to completed.
- 16 Dec 2016 According to a Celsion Corporation media release, company presented the final overall survival data from the Chinese patient cohort of the HEAT study in a recent meeting with the China Food and Drug Administration (CFDA). The CFDA informed Celsion, successful Phase 3 OPTIMA trial could serve as the basis for a direct regulatory filing in China without the need to file for prior approval in the U.S. or European Union. This could accelerate launch of ThermoDox in China than expected.
- 30 Nov 2016 Results results from an independent retrospective analysis conducted by the National Institutes of Health (NIH) on the intent-to-treat population published in a Celsion Corporation media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History