Randomised Phase II Study of Postoperative Hepatic Arterial Infusion Chemotherapy (Interferon/Fluorouracil Versus Low-dose Cisplatin/Fluorouracil) for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus.
No standard treatment has been established for highly advanced hepatocellular carcinoma
(HCC) invading the major branches of the portal vein except for sorafenib. Some reports
suggested that hepatic arterial infusion chemotherapy improved survival of these patients.
Other reports indicated surgical intervention improved that survival. However, there is no
standard adjuvant therapy after liver resection for the patients with HCC with portal vein
tumor thrombus in the main or first branch of the portal vein. Our preliminary results
showed that combined interferon-alpha and intra-arterial 5-fluorouracil (5-FU) as a
postoperative therapy prolonged disease-free and overall survival after liver resection.
Hepatic arterial infusion chemotherapy using low-dose 5-FU and cisplatin is also promising
regimen for advanced HCC.
Herein, the investigators planed the study to evaluate efficacy (two year survival as
primary outcome, and overall-survival as secondary outcome) and safety ( as secondary
outcome) in hepatic arterial infusion chemotherapy with continuous infusion of
5-fluorouracil and systemic administration of interferon-alpha or low-dose 5-FU and
cisplatin, and to compare the efficacy as randomized control trial.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Two-year overall survival rate
Duration: From randomization to evidenced death. Rate: Number of patients with evidenced death / number of total patients. 2 year survival rate: survival rate at two-year from the randomization
Hiroaki Nagano, MD, PhD
Osaka University, Graduate School of Medicine
Japan: Institutional Review Board