The Effect of Postoperative Interferon-alpha Treatment in Patients Underwent Curative Surgery for Hepatocellular Carcinoma With a Low miR-26 Expression: a Multi-center Randomized Clinical Trial.

Fecha de inicio: 1 de agosto de 2012

Perioperative Period Inclusion Criteria: Signed informed consent; Aged ≥ 18 years and ≤ 75 years old, male or female； Patients with a low miR-26 expression in tumor (confirmed by RT-PCR) underwent a curative resection of HCC; The tumor characteristics must meet the following: tumor diameter is between 3 to 8 centimeters,and the number of tumor is less than 3 no thrombosis is detected in the main branches of the portal vein, hepatic vein and bile duct by preoperative imaging or by intra-operative findings no extrahepatic and lymph node metastasis Perioperative Period Exclusion Criteria: Concomitant malignant primary tumor(s) in other systems is/are present; The subject receives any previous systemic anti-HCC therapy prior to the resection surgery, such as liver transplantation, intervention, ablation, radiotherapy, chemotherapy, molecular targeted therapy or other anti-HCC therapy; The subject takes other study/investigational drugs during this study; The subject has cerebrovascular accident, renal insufficiency, depression, hyperthyreosis, hypothyroidism or other severe uncontrolled diseases; The subject has a history of study drug or similar drug allergy. Baseline (Post-Surgery 4 to 6 weeks) Inclusion Criteria: Baseline (post-resection) blood routine examination shows that the number of leukocyte>2.5*10^9/L and platelet count>40*10^9/L; Child-Pugh score of class A at baseline. Baseline (Post-Surgery 4 to 6 weeks) Exclusion Criteria: Concomitant malignant primary tumor(s) in other systems is/are present; The subject takes other study/investigational drugs within 4 weeks prior to randomization; The baseline examination indicates that infection, bleeding, bile leakage, or other postoperative complications are present; The baseline examination suggests the presence of tumor metastasis; The subject has cerebrovascular accident, renal insufficiency, depression, hyperthyreosis, hypothyroidism or other severe uncontrolled diseases; The subject has a history of investigational drug or similar drug allergy; The subject is pregnant, lactating, or urine pregnancy test result is positive.