The Effect of Postoperative Interferon- Alpha Treatment in Low miR-26 Expression Patients With Hepatocellular Carcinoma: a Muti-center Randomized Clinical Trail.
BACKGROUND: Postoperative interferon-alpha (IFN-alpha) therapy improved survival in patients
with hepatocellular carcinoma (HCC). MiR-26 is a predictive marker for the efficiency of
postoperative interferon-alpha treatment in patients with HCC. Our study is to identify the
Efficiency of Postoperative IFN-Alpha Treatment in low miR-26 expression Patients With HCC.
METHODS: A quantitative reverse-transcriptase-polymerase-chain-reaction assays of miR-26 are
performed on specimens which are collected from patients who underwent a curative resection
of HCC. These patients with low miR-26 expression will return to the hospital 25±5 days
after the resection following the baseline examination. If all requirements are satisfied,
these patients will be randomly divided into the treatment group who received postoperative
IFN-alpha therapy or the comparison group who not received any treatment. Besides the
disease-free survival rate, the overall survival rate, time to recurrence and the side
effect will be observed.
Anticipated RESULTS: IFN alpha treatment improved the disease-free survival and the overall
survival in low miR-26 expression patients with HCC after curative resection, probably by
postponing recurrence.
Perioperative Period
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
disease free survival
5 years
No
Jia Fan, MD, PHD
Principal Investigator
Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China
China: Ethics Committee
LCI IFNa miR-26
NCT01681446
August 2012
February 2015
Name | Location |
---|---|
National Cancer Institute, NIH, US | Bethesda, Maryland 20892 |