TACE is considered the standard treatment for unresectable HCC and is widely used as a palliative treatment. However there is no consensus of the protocol of TACE.One of the variation is does the stability of the suspension by emulsified the lipiodol and the contrast medium used to dissolve the anticancer agents really effect the survival.Thus the investigators conduct this prospective,randomized controlled study to find out if the different method of preparing chemotheraputic drugs can cause a different survival benefit.
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. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
812
TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in distilled water and emulsified lipiodol followed embolization with polyvinyl alcohol particles (PVA)
TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water,then emulsified with lipiodol followed embolization with polyvinyl alcohol particles (PVA)
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
overall survival
Time frame: 3 year
Time to progression
Time frame: 3 year
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