Comparison of Two Solvents Used With Chemotherapy Agent for Transarterial Chemoembolization of Hepatocellular Carcinoma
Transcatheter arterial chemoembolization is currently the mainstays of palliative treatments
worldwide for patients with unresectable HCC. However there is no standard protocol exists
for TACE currently. One of the controversy is does the way of emulsified the anticancer
agents and lipiodol to get a high stability suspension really effect the survival rates.
Anticancer drugs play important role in survival benefit from our RCTs research (not
released). Many studies have innovated different methods to get a high stability suspension
of lipiodol and anticancer drugs ,because they think lipiodol can selectively retained in
HCC and used as a drug-carrying which allow a slow release of the anticancer drug from
lipiodol microdroplets. Thus ,A stability suspension might get a maximize tumor drug
uptake,which can caused a more tumor necrosis, and minimize systemic drug levels ,which get
a less toxicity, hence survival benefit. While the other researcher think a stability
emulsion can't get a positive effect ,such as pharmacokinetic and systematic toxicity of the
anticancer drugs, tumor response, biologic response and so on.
In conclude, there is no consensus in the method of combining the drugs. The variation of
the regime is great. Because there is no hard-evidence proved which protocol is better than
other by survival benefit.Thus, the investigators conduct the clinical trial with two arms
,which one is a traditional and classical regime administrated by us while the other is a
more stability suspension approved by many researchers, to prospectively study does the
stability suspension really effect the patient's survival based on multivariate analysis of
prognostic factors . The study had two interim analysis to allow the trial to be stopped if
significant differences were detected. The accumulated data were examined when one third
patient was enrolled in the clinical trial.
Comparison(s): In patients with HCC who underwent TACE therapy, stratified by whether they
have vascular invasion, we study the differences of survival between two regimens of
transcatheter arterial chemoembolization.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Cancer Center, Sun Yat-set University
China: Ministry of Health