The purpose of this study is to test the safety of gemcitabine and oxaliplatin regimen and to see its effects on sorafenib treatment failed hepatocellular carcinoma patients.
Patients who progressed after or cannot tolerate sorafenib treatment. Patients who cannot receive sorafenib for other reason are also permitted. Treatment is given in cycles, each cycle is 2 weeks long. Tumor measurements by CT and/or MRI will be repeated every 3 cycles. Patients will continue to receive study treatment as long as there is no disease progression or unacceptable side affects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Gemcitabine 1,000 mg/m2 infusion for 30minutes and followed by oxaliplatin 100mg/m2 infusion for 2hours on day1. All drugs were administered intravenously until progression, intolerance, patient withdrawal, or death.
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Progression free survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
Time frame: 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Overall safety profile verified as relevance of adverse events and laboratory abnormality based on CTCAE v4.0.
Time frame: From enrollment to 30 days follow-up after the end of treatment
Response rate
Assessed by RECIST 1.1
Time frame: from enrollment to 1 year follow-up after the end of treatment
Overall survival
Estimated by the Kaplan-Meier method
Time frame: From enrollment to 1 year follow-up after the end of treatment
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