Clinical Trials/NCT02716766

NCT02716766

Completed

Phase 2

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

The University of Hong Kong1 site in 1 country46 target enrollmentMarch 2016

ConditionsCarcinoma, Hepatocellular Secondary

InterventionsSorafenib Capecitabine Oxaliplatin

DrugsSorafenib Capecitabine Oxaliplatin

Overview

Phase: Phase 2
Intervention: Sorafenib
Conditions: Carcinoma, Hepatocellular
Sponsor: The University of Hong Kong
Enrollment: 46
Locations: 1
Primary Endpoint: Time to progression (TTP)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

September 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The University of Hong Kong

Responsible Party

Sponsor

Eligibility 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 ≤
•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.

Arms & Interventions

SECOX

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

Intervention: Sorafenib

SECOX

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

Intervention: Capecitabine

SECOX

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

Intervention: Oxaliplatin

Sorafenib

Sorafenib 400 mg twice daily from Day 1 to 14

Intervention: Sorafenib

Outcomes

Primary Outcomes

Time to progression (TTP)

Time Frame: Approximately 18 months

Time from study treatment to radiological progression

Secondary Outcomes

Objective Response Rate (ORR)(Approximately 18 months)
Progression-free survival (PFS)(Approximately 18 months)
Overall survival (OS)(Approximately 33 months)
Frequency and severity of adverse events and laboratory abnormalities(Approximately 18 months)