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.
试验速览
- 阶段
- 3 期
- 入组人数
- 296
- 试验地点
- 5
- 主要终点
- disease free survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
interferon-alpha (IFN-alpha)
interferon-alpha is intramuscularly or subcutaneously injected at 30 μg three times a week or 50 μg twice a week for 18 months
干预措施: interferon-alpha (IFN-alpha) (Drug)
结局指标
主要结局
disease free survival
时间窗: 5 years
interval between the dates of surgery and tumor recurrence or patient death
次要结局
- overall survival(5 years)
- time to recurrence(5 years)
- Number of Participants with Adverse Events(eighteen months)
研究者
Jia Fan
Professor of Surgery
Fudan University