Sorafenib With Capecitabine and Oxaliplatin for Advanced or Metastatic Hepatocellular Carcinoma

• Status: Unknown status
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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 endothelial growth factor (VEGF) are both overexpressed in HCC and thought to contribute to tumor development. Oxaliplatin in combination with other chemotherapies or biologic agents have been shown to be an effective and safe treatment in advanced HCC patients.

Sorafenib, an oral multi-kinase inhibitor, blocks tumor cell proliferation by targeting multiple growth factor pathways and also exerts an anti-angiogenic effect. Clinically, single agent Sorafenib has been shown to have some efficacy in patients with advanced HCC and the primary result of prolonged overall survival seems to have been achieved in the phase III trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Capecitabine; Niacinamide; Oxaliplatin; Sorafenib

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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