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

NCT02716766 | Completed Phase 2

• 1 other identifier: HKU-MONC-HCC-001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Hepatocellular; Secondary

Keywords

Sorafenib; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Time to progression (TTP)

  Time from study treatment to radiological progression

  Approximately 18 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Approximately 18 months

• Progression-free survival (PFS)

  Approximately 18 months

• Overall survival (OS)

  Approximately 33 months

• Frequency and severity of adverse events and laboratory abnormalities

  Approximately 18 months

Other Outcomes (1)

• Quality of life (QoL)

  Baseline, up to approximately 18 months

Study Arms (2)

SECOX

EXPERIMENTAL

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; Drug: Capecitabine; Drug: Oxaliplatin

Sorafenib

ACTIVE COMPARATOR

Sorafenib 400 mg twice daily from Day 1 to 14

Drug: Sorafenib

Interventions

Sorafenib DRUG

PO

Also known as: Nexavar

SECOX; Sorafenib

Capecitabine DRUG

PO

Also known as: Xeloda

SECOX

Oxaliplatin DRUG

IV

SECOX

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasm Metastasis

Interventions

Sorafenib; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes

Study Officials

• Thomas Yau, MD

  The University of Hong Kong

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 23, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: April 10, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)