Unresectable or Metastatic Hepatocellular Carcinoma Clinical Trial
Official title:
A Phase II Study of Temsirolimus as Second-line Therapy in Patients With Advanced, Unresectable Hepatocellular Carcinoma
The purpose of this study is to evaluate the activity of temsirolimus in patients who have advanced hepatocellular carcinoma (HCC) and have been treated with one previous chemotherapy or biologic therapy like sorafenib, but have experienced disease progression or intolerance to that therapy.
Currently, no standard therapy exists for patients who progress on sorafenib. mTOR signaling
is often up-regulated in HCC promoting cell growth and survival. This process is inhibited
by rapamycin, a specific inhibitor of mTOR. Temsirolimus, a rapamycin analog, may delay
tumor progression by inhibiting mTOR in HCC.Intervention: Temsirolimus IV
Eligible patients will receive temsirolimus IV on days 1,8,15 every 21 days. Treatment will
continue till disease progression or untolerable side effects
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment