This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
⢠To establish the maximum tolerated dose (MTD) and a suitable dose for Phase II evaluation of Torisel® given as a weekly dose in patients with advanced hepatocellular carcinoma (HCC)