Study of SECOX Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (HCC)
Phase 2
Completed
- Conditions
- SecondaryCarcinoma, Hepatocellular
- Interventions
- Registration Number
- NCT02716766
- Lead Sponsor
- The University of Hong Kong
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sorafenib Sorafenib Sorafenib 400 mg twice daily from Day 1 to 14 SECOX Sorafenib 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 SECOX Capecitabine 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 SECOX Oxaliplatin 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
- Primary Outcome Measures
Name Time Method Time to progression (TTP) Approximately 18 months Time from study treatment to radiological progression
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong