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

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

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.