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

Trial Profile

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Aug 2017

At a glance

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

    • 07 Aug 2017 According to a Celsion Corporation media release, 275 patients have been enrolled as of April 2017.
    • 07 Aug 2017 According to a Celsion Corporation media release, has completed a planned interim analysis of the first 50% of patients randomized in the trial as of April 2017 for safety and efficacy and unanimously recommended that the study continue according to protocol.
    • 12 May 2017 According to a Celsion Corporation media release, the company to activate 5 additional clinical trial sites in Vietnam by the second quarter of 2017.
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