Carcinoma, Hepatocellular, Secondary
Conditions
Keywords
Sorafenib, Drug Therapy
Brief 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.
Interventions
DRUGSorafenib
PO
DRUGCapecitabine
PO
DRUGOxaliplatin
IV
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression (TTP) | Approximately 18 months | Time from study treatment to radiological progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Approximately 18 months | Proportion of patients with a complete response (CR) or partial response (PR) |
| Progression-free survival (PFS) | Approximately 18 months | Time from study treatment to radiological disease progression or death due to any causes |
| Overall survival (OS) | Approximately 33 months | Time from study treatment to the date of death due to any cause or last follow-up date |
| Frequency and severity of adverse events and laboratory abnormalities | Approximately 18 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (QoL) | Baseline, up to approximately 18 months | Changes in patient-reported QoL status is assessed using EORTC core quality of life questionnaire QLQ-C30 with the HCC-specific module EORTC QLQ-HCC18. EORTC QLQ-HCC18 is an 18-item questionnaire designed to be used along with the 30-item EORTC QLQ-C30. EORTC QLQ-HCC18 questionnaire includes 8 symptom scales such as fatigue, jaundice, nutrition, pain, fever, abdominal swelling, sexual interest, and body image. These scores range from 0-100 for the role functioning scale, physical function scale and the other QLQ-C30 scales and HCC18 symptom complexes. |
Countries
Hong Kong
Outcome results
None listed