Adjuvant IFN-α for Patients Underwent Curative Surgery for HCC With a Low miR-26 Expression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: interferon-alpha (IFN-alpha)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: interferon-alpha (IFN-alpha)<br>interferon-alpha is intramuscularly or subcutaneously injected at 30 μg three times a week or 50 μg twice a week for 18 months | Drug: interferon-alpha (IFN-alpha)<br>* interferon-alpha is intramuscular injected 30 μg three times a week or 50 μg twice a week for 18 months<br>* Other names: SINOGEN;|
| No Intervention: control<br>no anti-cancer interventions were assigned | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival | interval between the dates of surgery and tumor recurrence or patient death | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | interval between the dates of surgery and patient death | 5 years | 
| time to recurrence | interval between the dates of surgery and tumor recurrence | 5 years | 
| Number of Participants with Adverse Events | Number of Participants with Adverse Events（hypohepatia,fever,leukopenia and thrombopenia）will be measured | eighteen months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interferon-alpha, miR-26, hepatocellular carcinoma