Chemoembolization of Unresectable Hepatocellular Carcinoma With or Without Lipiodol: Effectiveness and Safety. A Prospective and Randomized Clinical Trial.
TACE is the most widely used therapy in patients with HCC who are considered to be
unsuitable candidates for curative therapy.And the regimen of TACE with anticancer agents
and followed embolic particles has become a standard treatment for unresectable
hepatocellular carcinoma. However, there are variety TACE protocols with different
chemotherapeutic agents（combined or alone）,which mixed with lipiodol or not,different
embolic agents(temporary or permanent ) and how these drugs combine. Currently, no standard
protocol exists for TACE. One of the controversy is what's the mechanism of lipiodol. This
disparity in the literature is the effectiveness of the lipiodol is unclear: some study
reveal a regimen contain lipiodol can improves survival ,while the other research consider
there is no any statistical significances in survival,but also aggravate the side effects.
Thus , The purpose of the investigators' study is to prospectively study the efficacy of
lipiodol in transcatheter arterial Chemoembolization with two kinds of regimens for
nonresectable hepatocellular carcinoma based on multivariate analysis of prognostic
factors. The study had a interim analysis to allow the trial to be stopped if significant
differences were detected. The accumulated data were examined when half 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.
Eligibility criteria:1-Inclusion Criteria；
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Ming Shi, MD
Cancer Center, Sun Yat-set University
China: Ministry of Health