Oncology drug developer Celsion has won clinical trial approval from the China Food and Drug Administration to conduct an ongoing phase III study evaluating ThermoDox at clinical sites in China.
ThermoDox is a heat-activated liposomal encapsulation of doxorubicin. The OPTIMA study is assessing ThermoDox's performance in combination with radiofrequency ablation standardized to 45 minutes versus radiofrequency ablation alone for treating patients with primary liver cancer.
The study is expected to enroll up to 550 patients around the world, and it currently includes patients at 50 clinical sites in 12 different countries in North America, Europe, and Asia Pacific. The China Food and Drug Administration approval will allow Celsion to enroll patients at up to 25 additional clinical sites in China, which will allow the firm to complete enrollment in the study by the end of 2017.
![Images show the pectoralis muscles of a healthy male individual who never smoked (age, 66 years; height, 178 cm; body mass index [BMI, calculated as weight in kilograms divided by height in meters squared], 28.4; number of cigarette pack-years, 0; forced expiratory volume in 1 second [FEV1], 97.6% predicted; FEV1: forced vital capacity [FVC] ratio, 0.71; pectoralis muscle area [PMA], 59.4 cm2; pectoralis muscle volume [PMV], 764 cm3) and a male individual with a smoking history and chronic obstructive pulmonary disorder (COPD) (age, 66 years; height, 178 cm; BMI, 27.5; number of cigarette pack-years, 43.2, FEV1, 48% predicted; FEV1:FVC, 0.56; PMA, 35 cm2; PMV, 480.8 cm3) from the Canadian Cohort Obstructive Lung Disease (i.e., CanCOLD) study. The CT image is shown in the axial plane. The PMV is automatically extracted using the developed deep learning model and overlayed onto the lungs for visual clarity.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/03/genkin.25LqljVF0y.jpg?auto=format%2Ccompress&crop=focalpoint&dpr=2&fit=crop&h=167&q=70&w=250)
