Inoperable HCC
Conditions
Brief summary
This is a phase I/II study to evaluate dose limited toxicity and efficacy of Torisel
Interventions
DRUGTorisel
Torisel will be administered intravenously as an IV infusion over a 30-minute period in adult clinical studies.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • 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) | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| • To determine overall survival (OS) | 4 years |
| • To determine progression-free survival (PFS) in patients with advanced hepatocellular carcinoma (HCC) treated with Torisel® | 4 Years |
| • To correlate stathmin expression in pre-treatment HCC tumour biopsies and clinical response to Torisel® | 2 years |
| • To determine duration of response (DR) | 2 years |
| • To determine clinical benefit rate (CBR, percent of patients experiencing CR, PR or SD ≥ 12 weeks) | 2 years |
| • To determine and establish the safety and toxicity profile of Torisel® and to identify any dose limiting toxicities (DLTs) in advanced HCC | 2 Years |
| • To determine the response rate (CR and PR) based on RECIST criteria | 2 years |
Countries
Hong Kong
Outcome results
None listed