Maintenance of Sorafenib Following Combined Therapy of Three-dimensional Conformal Radiation Therapy/Intensity-modulated Radiation Therapy and Transcatheter Arterial Chemoembolization in Patients With Locally Advanced Hepatocellular Carcinoma: a Phase I/II Study.
Patients with solitary lesion (bigger than 5 cm in diameter) histologically or cytologically
confirmed HCC receive TACE (1-3 cycles) plus 3DCRT/IMRT 4-6 weeks later. Maintenance
Sorafenib will be administered only for the patients with non-progression disease 4 to 6
weeks after the completion of radiotherapy. The dose will be 400 mg, p.o., twice a day.
Sorafenib will be continuously given for 12 months unless intolerable toxicities and/or
tumor progression. Hypothesis of the current study is that Sorafenib as a maintenance
therapy after combined therapy of 3DCRT/IMRT and TACE is safe and superior to radiotherapy
combined with TACE alone in terms of time to progression (TTP), progression-free survival
(PFS) and overall survival (OS) in comparison to historical data.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The safety and tolerability of maintenance Sorafenib.
Guo-liang Jiang, M.D.
China: Food and Drug Administration