A phase II study of etoposide, oxaliplatin and capecitabine in patients with advanced hepatocellular carcinoma
- Conditions
- Advanced Hepatocellular carcinoma
- Registration Number
- EUCTR2005-003187-32-DK
- Lead Sponsor
- Department of Oncology, Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 39
Inclusion Criteria
Advanced hepatocellular carcinoma
Performance status 0-2
Age > 18
Life expectancy > 12 weeks
Adequate liver, renal and cardiac function
Negative pregnancy test for fertile women
Signed informed consent
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
Prior chemotherapy within last 4 weeks
Prior radiotherapy within last 4 weeks
Prior immunotherapy within last 4 weeks
Concurrent experimental therapy
Allergy to the IMPs
Known PDP defiency
Other malignacy within last 5 years
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaulate the efficacy of the combination of etoposide, oxaliplatin and capecitabine in patients with advanced hepatocellular carcinoma not suitable for local treatment options;Secondary Objective: Evaulate the safety and duration of response of the combination of etoposide, oxaliplatin and capecitabine in patients with advanced hepatocellular carcinoma not suitable for local treatment options;Primary end point(s): Response rate (RECIST criteria)<br>Toxicity (CTC v3.0 criteria)<br>Time to progression<br>survival
- Secondary Outcome Measures
Name Time Method