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

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ClinicalTrials.gov Identifier: NCT02716766
Recruitment Status : Active, not recruiting
First Posted : March 23, 2016
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Secondary Drug: Sorafenib Drug: Capecitabine Drug: Oxaliplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 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 : March 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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 Name: Nexavar

Drug: Capecitabine
PO
Other Name: Xeloda

Drug: Oxaliplatin
IV

Active Comparator: Sorafenib
Sorafenib 400 mg twice daily from Day 1 to 14
Drug: Sorafenib
PO
Other Name: Nexavar




Primary Outcome Measures :
  1. Time to progression (TTP) [ Time Frame: Approximately 18 months ]
    Time from study treatment to radiological progression


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Approximately 18 months ]
    Proportion of patients with a complete response (CR) or partial response (PR)

  2. Progression-free survival (PFS) [ Time Frame: Approximately 18 months ]
    Time from study treatment to radiological disease progression or death due to any causes

  3. Overall survival (OS) [ Time Frame: Approximately 33 months ]
    Time from study treatment to the date of death due to any cause or last follow-up date

  4. Frequency and severity of adverse events and laboratory abnormalities [ Time Frame: 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:
  1. Quality of life (QoL) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716766


Locations
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Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Study Chair: Thomas Yau, MD The University of Hong Kong

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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02716766     History of Changes
Other Study ID Numbers: HKU-MONC-HCC-001
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The University of Hong Kong:
Sorafenib
Drug Therapy

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Capecitabine
Oxaliplatin
Sorafenib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors