Spots Global Cancer Trial Database for Temsirolimus as Second-line Therapy in HCC

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Trial Identification

Brief Title: Temsirolimus as Second-line Therapy in HCC

Official Title: A Phase II Study of Temsirolimus as Second-line Therapy in Patients With Advanced, Unresectable Hepatocellular Carcinoma

Study ID: NCT01567930

Conditions

Unresectable or Metastatic Hepatocellular Carcinoma

Interventions

Temsirolimus

Study Description

Brief Summary: 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.

Detailed Description: 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