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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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2019

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At a glance

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

    • 08 Nov 2019 According to a Celsion Corporation media release, the company will host a conference call to discuss OPTIMA and OVATION 2 studies on Friday, November 15, 2019.
    • 04 Nov 2019 According to an Celsion Corporation media release, the 2nd pre-planned Interim Efficacy Analysis is projected for the 2nd quarter of 2020 following 158 patient deaths.
    • 04 Nov 2019 Results published in the Celsion Corporation Media Release.
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