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

Study Overview
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Brief Summary
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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.

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

Conditions
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Carcinoma, Hepatocellular, Secondary

Intervention / Treatment
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* Drug: Sorafenib
* Drug: Capecitabine
* Drug: Oxaliplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SECOX<br>Sorafenib 400 mg twice daily from Day 1 to 14, Capecitabine 850 mg/m2 twice daily from Day 1 to 7, Oxaliplatin 85 mg/m2 on Day 1 | Drug: Sorafenib<br>* PO<br>* Other names: Nexavar;Drug: Capecitabine<br>* PO<br>* Other names: Xeloda;Drug: Oxaliplatin<br>* IV<br>|
| Active Comparator: Sorafenib<br>Sorafenib 400 mg twice daily from Day 1 to 14 | Drug: Sorafenib<br>* PO<br>* Other names: Nexavar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression (TTP) | Time from study treatment to radiological progression | Approximately 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | Proportion of patients with a complete response (CR) or partial response (PR) | Approximately 18 months | 
| Progression-free survival (PFS) | Time from study treatment to radiological disease progression or death due to any causes | Approximately 18 months | 
| Overall survival (OS) | Time from study treatment to the date of death due to any cause or last follow-up date | Approximately 33 months | 
| Frequency and severity of adverse events and laboratory abnormalities | Type, frequency, severity of adverse events (AEs) and laboratory abnormalities as graded by NCI CTCAE v4.03, and their seriousness and relationship to study medications | Approximately 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sorafenib, Drug Therapy