Behandlung des fortgeschrittenen hepatozellulären Karzinoms mit dem mTOR-Inhibitor Rapamycin (HCC-Rap-001)Treatment of advanced hepatocellular carcinoma with the mTOR-inhibitor rapamycin (HCC-Rap-001) - treatment of HCC with rapamyci
- Conditions
- Advanced hepatocellular carcinoma (HCC)
- Registration Number
- EUCTR2004-002834-20-AT
- Lead Sponsor
- niversitätsklinik für Innere Medizin IV, Klinische Abteilung Gastroenterologie und Hepatologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Aim of the study: To study the tolerability and efficacy of rapamycin in patients with advanced hepatocellar carcinoma without established therapeutic options. <br>;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
- Secondary Outcome Measures
Name Time Method