Hepatocellular Carcinoma Clinical Trial
Official title:
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.
To evaluate the efficacy and safety of postoperative hepatic arterial infusion chemotherapy, interferon/fluorouracil versus low-dose cisplatin/fluorouracil, in patients with 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.
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