OPTIMA global study of ThermoDox as HCC therapy launches in China

Celsion Corporation announced the launch of the OPTIMA study for primary hepatocellular carcinoma in China, which will investigate the safety and efficacy of ThermoDox plus radiofrequency ablation, according to a press release.

The OPTIMA study is a double blind, placebo-controlled phase 3 clinical trial where liposomal encapsulated doxorubicin (ThermoDox, Celsion) and standardized radiofrequency ablation (sRFA) will be used to treat patients with hepatocellular carcinoma (HCC) and be compared against controls treated with RFA alone. Over 500 patients will be enrolled globally, including patients from 20 different clinical sites in China.

The design of the OPTIMA study is based on the design and results of the HEAT study. In this study, a subgroup of patients (285/701) were treated with ThermoDox plus RFA and showed improved survival compared with patients treated with RFA alone, according to the release.

“With an extremely high incidence rate of HCC in China, the compelling survival data from the Chinese subgroup analysis in the HEAT Study underscores the importance of further exploring the potential that exists for ThermoDox in combination with sRFA to serve as a new curative treatment for primary liver cancer, a disease with limited treatment options,” Min Hua Chen, MD, chief expert from the department of ultrasonography at Peking University, China, and researcher in the OPTIMA study, said in the release. “It is a great honor to be involved with the OPTIMA study, and I look forward to working with Celsion and my research colleagues as the study progresses.”

Initiation of the phase 3 OPTIMA study was approved in Europe in November 2014.

Disclosure: Healio.com/Hepatology was unable to confirm relevant financial disclosures of Chen at the time of publication.