The purpose of this study is to determine whether compared with arsenic trioxide TACE alone, arsenic trioxide TACE and intravenous administration could further prolong the overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
258
Arsenic trioxide powder 20mg dissolved in lipiodol(the dosage of lipiodol is decided according to the volume of the target lesion)is used for transcatheter arterial chemoembolization(TACE). TACE will be repeated after 4\~6 weeks if it is necessary according to the assessment from imaging modalities
Arsenic trioxide intravenous infusion: arsenic trioxide powder 0.15mg/Kg/d(maxim 10mg/d) dissolved in 250ml 0.9%NaCl solution is used for intravenous infusion.Every course will last for 3 weeks and the next course will be continued after 1 week suspension.Intravenous infusion will be suspended 3 days before and 7\~14 days after TACE.
Lipiodol is used to dissolve arsenic trioxide for TACE,with the dosage decided according to the volume of the target lesion.
Time to Progression
Time to progression in our study is defined as the time from a patient's enrollment to the time for disease progression (according to Recist1.1).
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Overall Survival
Overall survival in our study is defined as the time from a patient's enrollment to the time for death.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Quality of Life
Quality of life is assessed according to the FACT-Hep questionnaire.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Safety
Safety of our treatment plan will be assessed according to the Common Terminology Criteria for Adverse Events(CTCAE) 3.0
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
250ml NaCl solution is used to dissolve the arsenic trioxide for intravenous infusion.