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Completed

NCT Number: NCT02716766

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

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.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Secondary

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Queen Mary Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sorafenib

Drug

PO

Other names: Nexavar

Capecitabine

Drug

PO

Other names: Xeloda

Oxaliplatin

Drug

IV

Primary outcomes

  1. Time to progression (TTP)

    Time frame: Approximately 18 months

    Time from study treatment to radiological progression

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 23, 2016
Registry last updated
Apr 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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