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

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

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Hepatocellular; Secondary
• Intervention / Treatment: Drug: Oxaliplatin; Drug: Sorafenib; Drug: Capecitabine

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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: Oxaliplatin; IV; Drug: Sorafenib; PO; Other Names: Nexavar; Drug: Capecitabine; PO; Other Names: Xeloda
Active Comparator: Sorafenib; Sorafenib 400 mg twice daily from Day 1 to 14	Drug: Sorafenib; PO; Other Names: Nexavar

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (QoL)	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.	Baseline, up to approximately 18 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Study Chair: Thomas Yau, MD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: March 9, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (Estimate): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Sorafenib; Drug Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib; Capecitabine; Oxaliplatin
• Other Study ID Numbers: HKU-MONC-HCC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO