CLSN trial failure is not good news for HCC patients. I listened the CLSN call and they said that distant liver tumor recurrence was one of the reason for failed hFPS. I do see two possible reasons for CLSN failure.
- The thermodox chemo dose concentration is not high enough to have sustained anti cancer response. Liver is a notorious organ to break down low dose chemo.
- The approach is very focal in nature i.e drug is released near the heated metal when DOXO filled lipo ruptures due to heat.
Most of the recurrence happens due to distant metastasis , that is the reason thermodox could not show any efficacy as compared to RFA alone.
Delcath Chemosat system address both of these problem i.e high dose and whole organ therapy. Chemosat system delivers 10 times chemo dose as compared to Thermodox to entire liver. This whole organ high dose chemo allows sustained tumor response , as it was shown in Delcath P3 trial for metastatic melanoma .CLSN failure provides a very good opportunity for DCTH to engage a partner to start HCC trial with DOXO filter. At present Chemosat is the only option left for late stage HCC patient who can not tolerate Nexavar.