Celsion Corporation (CLSN)

[Biobonic]

Thanks

Found the article here

Further info:

We hypothesized that RFA + LTLD efficacy would be superior to RFA alone among patients with unresectable intermediate-size HCC lesions. Instead, median PFS and interim OS were similar in both study arms. In trying to understand these results, we noted a wide variation in RFA dwell times between the 66 active centers. The study did not require minimum dwell times because the manufacturers of the FDA-approved RFA devices used in this study do not recommend minimum dwell times nor do guidelines exist. Beyond the criterion for RFA adequacy, which was ablation of each target lesion plus a 360° 1-cm tumor margin, no attempt was made to manage RFA dwell time in the HEAT Study.

In the end, this was a negative study. The post hoc analyses are clearly hypotheses generating only and require clinical validation. This is now being performed in the prospective phase III OPTIMA study, designed to control for RFA dwell time. We are hoping to learn from the current study and impact future development of LTLD in HCC.