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: 09 Apr 2018

At a glance

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

    • 09 Apr 2018 According to a Celsion Corporation media release, data from the first interim efficacy results is expected early in the second quarter of 2019.
    • 09 Apr 2018 Results presented in the Celsion Corporation media release.
    • 09 Apr 2018 According to a Celsion Corporation media release, independent Data Monitoring Committee has completed planned safety and data review and recommended to continue the study based on the safety data from 411 patients. 75% patients randomized as of February 5, 2018 and 80% till date.
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