Study of SECOX Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (HCC)
NCT ID: NCT02716766
Last Updated: 2020-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2016-03-31
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Sorafenib
PO
Capecitabine
PO
Oxaliplatin
IV
Sorafenib
Sorafenib 400 mg twice daily from Day 1 to 14
Sorafenib
PO
Interventions
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Sorafenib
PO
Capecitabine
PO
Oxaliplatin
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Principal Investigators
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Thomas Yau, MD
Role: STUDY_CHAIR
The University of Hong Kong
Locations
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Queen Mary Hospital
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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HKU-MONC-HCC-001
Identifier Type: -
Identifier Source: org_study_id
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