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A Phase IIa Trial of Sorafenib With Capecitabine and Oxaliplatin in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma

Phase 2
18 Years
80 Years
Open (Enrolling)
Advanced Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma

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Trial Information

A Phase IIa Trial of Sorafenib With Capecitabine and Oxaliplatin in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma

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 etiological causes of HCC are hepatitis B and hepatitis C viral infections.

HCC is a cancer of high particular relevance in Hong Kong because of the high prevalence
(10%) of hepatitis B virus infection in the population. It is the second most common cancer
causing death in Hong Kong. Surgical resection and liver transplantation are regarded as the
main curative treatments for HCC. Nevertheless, the majority of patients have unresectable
HCCs because of advanced tumor stage and poor liver function. Besides, transplantation is
indicated only for early small HCCs, and its application is limited by the shortage of liver
graft, which is a particularly severe problem in Hong Kong.

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.

Sorafenib has been approved by FDA for use in renal cell carcinoma based on prolonged
survival in phase III trials. Single agent Sorafenib has been shown to have some efficacy
in patients with advanced HCC and the primary result of prolonged overall survival have been
achieved in a recent randomized phase III trial. However, most patients would only have
disease stabilization as the phase II trial only showed a tumor response rate of only 8% (PR
& MR). Combination with chemotherapy may improve the tumor response rate.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

4 cycles

Safety Issue:



Hong Kong: Department of Health

Study ID:




Start Date:

September 2007

Completion Date:

December 2008

Related Keywords:

  • Advanced Hepatocellular Carcinoma
  • Metastatic Hepatocellular Carcinoma
  • Sorafenib
  • Capecitabine
  • Oxaliplatin
  • Advanced Hepatocellular Carcinoma
  • Metastatic Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular