The purpose of the study is to determine whether interferon-alpha is effective in prevention of tumor recurrence for the patients with a low miR-26 expression in tumor after curative resection of hepatocellular carcinoma.
BACKGROUND: Postoperative interferon-alpha (IFN-alpha) therapy improved survival in patients with hepatocellular carcinoma (HCC). MiR-26 is a predictive marker for the effect of postoperative interferon-alpha treatment in patients with HCC. Our study is to identify the effect of postoperative IFN-alpha treatment in patients with a low miR-26 expression in tumor after resection of HCC. METHODS: A quantitative RT-PCR 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 4 to 6 weeks after the resection following the baseline examination to rule out residual tumor. If all requirements are satisfied, these patients will be randomly assigned to the treatment group who received postoperative IFN-alpha therapy or the control group who will not receive any anti-cancer treatment. Disease-free survival, overall survival, time to recurrence and the side effects will be observed. Anticipated RESULTS: IFN-alpha treatment improved the disease-free survival in patients with a low miR-26 expression in tumor after curative resection of HCC, probably by inhibiting tumor recurrence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
296
interferon-alpha is intramuscular injected 30 μg three times a week or 50 μg twice a week for 18 months
The Mengchao hepatobiliary hospital,Fujian Medical University,and Liver disease research center of Fujian province
Fuzhou, Fujian, China
RECRUITINGZhongshan Hospital, Xiamen University
Xiamen, Fujian, China
RECRUITINGLiver Cancer Institute and Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
disease free survival
interval between the dates of surgery and tumor recurrence or patient death
Time frame: 5 years
overall survival
interval between the dates of surgery and patient death
Time frame: 5 years
time to recurrence
interval between the dates of surgery and tumor recurrence
Time frame: 5 years
Number of Participants with Adverse Events
Number of Participants with Adverse Events(hypohepatia,fever,leukopenia and thrombopenia)will be measured
Time frame: eighteen months
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ShanghaiBio Coorperation
Shanghai, Shanghai Municipality, China
RECRUITINGTumor Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality, China
RECRUITING