Study of SECOX Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (HCC)

Randomised Phase II Trial of Sorafenib, Capecitabine and Oxaliplatin (SECOX) Versus Single Agent Sorafenib in Patients With Advanced Hepatocellular Carcinoma

The purpose of this study is to determine if sorafenib, capecitabine and oxaliplatin (SECOX) regimen is more effective than sorafenib alone in the treatment of advanced liver cancer.

Inclusion Criteria:

• Advanced or metastatic hepatocellular carcinoma (HCC) not suitable for surgery or various loco-regional therapies.
• Diagnosis of HCC confirmed either by cyto-histological confirmation or by non-invasive criteria according to the European Association for Study of Liver disease (EASL) criteria.
• Child-Pugh A or B7 cirrhosis.
• Eastern Co-Operative Group (ECOG) performance status ≤ 2.
• Life expectancy of ≥ 12 weeks.
• Adequate organ function (blood transfusion or use of biologic response modifiers is not permitted).
• Measurable disease with at least one lesion, which is at least 1 cm in one dimension on computed tomography (CT) or magnetic resonance imaging (MRI).
• Able and willing to meet all protocol-required treatments, investigations and visits.
• Signed written informed consent form.

Exclusion Criteria:

• Prior systemic therapy for advanced HCC.
• Central nervous system (CNS) metastasis.
• History of liver transplantation.
• Peripheral sensory neuropathy with functional impairment before the first cycle of treatment.
• History of cardiac disease.
• Uncontrolled hypertension.
• Women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception.
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.