Status:
UNKNOWN
Sorafenib With Capecitabine and Oxaliplatin for Advanced or Metastatic Hepatocellular Carcinoma
Lead Sponsor:
The University of Hong Kong
Conditions:
Advanced Hepatocellular Carcinoma
Metastatic Hepatocellular Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
HCC is an aggressive, largely chemo-resistant cancer with a poor prognosis, currently there is no effective systemic chemotherapy for HCC. Epidermal growth factor receptor (EGFR) and vascular endothel...
Detailed Description
Hepatocellular carcinoma (HCC) is the most common primary liver malignancy, with an annual incidence of over 500,000 new patients and more than half of the new cases occur in China. The most common et...
Eligibility Criteria
Inclusion
- Patients with locally advanced or metastatic HCC not suitable surgical or locoregional therapies
- Age more than 18 years
- Performance status 0 or 1
- Life expectancy of 3 months
- Prior radiotherapy more than 3 weeks prior to study entry
- No prior systemic therapy
- Hb more than 8.5 g/dl
- ANC more than 1,500/mm3
- PLT more than 75 x 109/L
- PT-INR/PTT less than 1.5 x upper limit of normal
- Total bilirubin of less than 1.5 x upper limit of normal
- Serum creatinine less than 1.5 x upper limit of normal
- Serum AST and ALT less than 2.5 x upper limit of normal
Exclusion
- History of cardiac disease
- Symptomatic metastatic brain or meningeal tumors
- Main portal vein tumor thrombosis
- Ascites uncontrolled by medication
- Variceal or gastrointestinal bleeding within three months prior to start of treatment
- Seizure disorder requiring medication
- Patients undergoing renal dialysis
- Previous or concurrent cancer that is distinct in primary site
- Prior use of any systemic anti-cancer treatment
- Prior use of Raf-kinase inhibitors (RKI), VEGF inhibitors, MEK inhibitors or Farnesyl transferase inhibitors
- Patients on any local ablative treatment or TACE within 6 weeks
- Radiotherapy during study or within 3 weeks
- Major surgery within 4 weeks
- Concomitant treatment of rifampin or St John's Wort
- Pregnant or breast-feeding patients
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00752063
Start Date
September 1 2007
End Date
December 1 2008
Last Update
September 15 2008
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, China