Hepatocellular Carcinoma (HCC)_Torisel_

Phase I/II Study of Temsirolimus (Torisel®) as Novel Therapeutic Drug for Patients With Unresectable Hepatocellular Carcinoma (HCC)- A Correlative Study With Stathmin Over-expression

This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel

Inclusion Criteria:

• Histologically confirmed hepatocellular carcinoma that is not amenable to curative resection
• measurable disease
• Age >=18 years.
• Life expectancy of greater than 12 weeks.
• ECOG performance status <= 2
• Prior systemic therapy for HCC is allowed
• Adequate haematologic, renal and hepatic function
• Absence of cirrhosis or Child's A cirrhosis
• Fasting total cholesterol <9.1 mmol/liter and fasting triglyceride level <4.5 mmol/liter)

Exclusion Criteria:

• Patients who have had systemic therapy or radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
• Patients receiving any other investigational agents concurrently.
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Uncontrolled intercurrent diseases such as, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women.