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

Sponsor

The University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT02716766

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Hepatocellular Secondary	Drug: Sorafenib Drug: Capecitabine Drug: Oxaliplatin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Sep 1, 2018

Actual Study Completion Date :

Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Sorafenib PO Other Names: Nexavar Drug: Capecitabine PO Other Names: Xeloda Drug: Oxaliplatin IV
Active Comparator: Sorafenib Sorafenib 400 mg twice daily from Day 1 to 14	Drug: Sorafenib PO Other Names: Nexavar

Arm

Intervention/Treatment

Experimental: 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

Drug: Sorafenib

Other Names:

Nexavar

Drug: Capecitabine

Other Names:

Xeloda

Drug: Oxaliplatin

Active Comparator: Sorafenib

Sorafenib 400 mg twice daily from Day 1 to 14

Drug: Sorafenib

Other Names:

Nexavar

Outcome Measures

Primary Outcome Measures

Time to progression (TTP) [Approximately 18 months]
Time from study treatment to radiological progression

Secondary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.