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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Oct 2017

At a glance

  • Drugs Doxorubicin liposomal (Primary)
  • Indications Liver cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms HEAT
  • Sponsors Celsion Corporation
  • Most Recent Events

    • 10 Oct 2017 Results of post-hoc subset analysis were published in the Clinical cancer research: an official journal of the American Association for Cancer Research
    • 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.
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