Status:
COMPLETED
Hepatocellular Carcinoma (HCC)_Torisel_
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Inoperable HCC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01251458
Start Date
October 1 2009
End Date
January 1 2016
Last Update
September 28 2016
Active Locations (1)
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1
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong