The Efficacy, Safety, and Patient Reported Outcomes of Different Regimens of Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma
Transarterial chemoembolization (TACE) has been recommended as first line non-curative
therapy for non-surgical patients with large/multifocal HCC who do not have vascular
invasion or extrahepatic spread. There has not been any standardized protocol in the choice
of chemotherapeutic agents, dosage, dilution, rate of injection, and time interval between
treatments. Similarly, there is no agreement on the choice of embolizing agents, degree of
embolization, and whether the chemotherapeutic agent should be given together, or before the
embolizing agent.
Comparison(s): In patients with HCC who underwent TACE therapy, stratified by whether they
have vascular invasion and tumor size, we compare efficacy, safety, and patient reported
outcomes (PRO) of different regimens of TACE.
Regimen 1: lipiodol combined chemotherapy with embolization
Regimen 2: lipiodol combined chemotherapy without embolization
Regimen 3: lipiodol single agent chemotherapy with embolization
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Overall survival
3 years
Yes
Jin-Qing Li, M.D.
Principal Investigator
Cancer Center, Sun Yat-set University
China: Ministry of Health
hcc-001
NCT00493402
July 2007
December 2010
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