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: 27 Apr 2017

At a glance

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

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top