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

Primary Purpose

Carcinoma, Hepatocellular, Secondary

Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Sorafenib
Capecitabine
Oxaliplatin
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Sorafenib, Drug Therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Queen Mary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SECOX

Sorafenib

Arm Description

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

Sorafenib 400 mg twice daily from Day 1 to 14

Outcomes

Primary Outcome Measures

Time to progression (TTP)
Time from study treatment to radiological progression

Secondary Outcome Measures

Objective Response Rate (ORR)
Proportion of patients with a complete response (CR) or partial response (PR)
Progression-free survival (PFS)
Time from study treatment to radiological disease progression or death due to any causes
Overall survival (OS)
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
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

Full Information

First Posted
March 9, 2016
Last Updated
April 9, 2020
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02716766
Brief Title
Study of SECOX Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (HCC)
Official Title
Randomised Phase II Trial of Sorafenib, Capecitabine and Oxaliplatin (SECOX) Versus Single Agent Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular, Secondary
Keywords
Sorafenib, Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SECOX
Arm Type
Experimental
Arm Description
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
Arm Title
Sorafenib
Arm Type
Active Comparator
Arm Description
Sorafenib 400 mg twice daily from Day 1 to 14
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Other Intervention Name(s)
Nexavar
Intervention Description
PO
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
PO
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
IV
Primary Outcome Measure Information:
Title
Time to progression (TTP)
Description
Time from study treatment to radiological progression
Time Frame
Approximately 18 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Proportion of patients with a complete response (CR) or partial response (PR)
Time Frame
Approximately 18 months
Title
Progression-free survival (PFS)
Description
Time from study treatment to radiological disease progression or death due to any causes
Time Frame
Approximately 18 months
Title
Overall survival (OS)
Description
Time from study treatment to the date of death due to any cause or last follow-up date
Time Frame
Approximately 33 months
Title
Frequency and severity of adverse events and laboratory abnormalities
Description
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
Time Frame
Approximately 18 months
Other Pre-specified Outcome Measures:
Title
Quality of life (QoL)
Description
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.
Time Frame
Baseline, up to approximately 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 ≤ 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Yau, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Study Chair
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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