Advanced hepatocellular carcinoma (HCC)
Conditions
Interventions
Product Name: Rapamune
Pharmaceutical Form: Coated tablet
INN or Proposed INN: sirolimus
CAS Number: n.a.
Current Sponsor code: n.a.
Other descriptive name: rapamycin
Sponsors
Universitätsklinik für Innere Medizin IV, Klinische Abteilung Gastroenterologie und Hepatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: histologically verified hepatocellular carcinoma, not suitable for surgery, liver transplantation, embolization, kryotherpay, ethanol instillation, radio frequency ablation. No previous therapy liver cirrhosis Child A or B Thrombocytes > 30.0 x 10E9 / L Leukozyten > 1.0 x 10E9 / L Age 19 - 85 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: WHO performance status > 2 estimated life expectancy < 3 months acute infection HIV positivity pregnancy, breast feeding, lack of contraception other malignant disease within past 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim of the study: To study the tolerability and efficacy of rapamycin in patients with advanced hepatocellar carcinoma without established therapeutic options. ;Secondary Objective: VEGF levels in plasma, PTEN mutations in tumour tissue.;Primary end point(s): side effects, response rate, duration of stable disease, time to progression, overall survival, quality of life | — |
Countries
Austria
Outcome results
None listed