Hepatocellular Carcinoma (HCC)_Torisel_

The Chinese University of Hong Kong

Status and phase

Completed

Phase 2

Phase 1

Conditions

Inoperable HCC

Treatments

Drug: Torisel

Study type

Interventional

Funder types

Other

Identifiers

HCC022

Details and patient eligibility

About

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

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.