The Effect of Postoperative Interferon- Alpha Treatment in Low miR-26 Expression Patients With HCC
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Purpose
The purpose of the study is to determine whether interferon-alpha is effective in the treatment of low miR-26 expression patients with HCC after curative resection.
| Condition | Intervention |
|---|---|
|
Hepatocellular Carcinoma |
Drug: interferon-alpha (IFN-alpha) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effect of Postoperative Interferon- Alpha Treatment in Low miR-26 Expression Patients With Hepatocellular Carcinoma: a Muti-center Randomized Clinical Trail. |
- disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- time to recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Number of Participants with Adverse Events [ Time Frame: eighteen months ] [ Designated as safety issue: Yes ]Number of Participants with Adverse Events(hypohepatia,fever,leukopenia and thrombopenia)will be measured
| Estimated Enrollment: | 506 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: interferon-alpha (IFN-alpha)
the interferon-alpha is intramuscular injected 3,000,000U three times a week for 18 months
|
Drug: interferon-alpha (IFN-alpha)
interferon-alpha is intramuscularly or subcutaneously injected at 3,000,000-5,000,000 U three times a week for 18 months
Other Names:
|
|
No Intervention: control
no interventions were assigned
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Perioperative Period Inclusion Criteria:
- Signed informed consent;
- Aged ≥ 18 years and ≤ 75 years old, male or female;
- Patients with low miR-26 expression(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 tnan 3
- no thrombosis is detected in the main branches of the portal vein, hepatic vein and bile duct
- no extrahepatic and lymphnode 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 (except 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-SurgeryDay 25 ± 5) 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-SurgeryDay 25 ± 5) 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.
Contacts and Locations| Contact: Mei-ling Li | 64041990 ext 2936 | livercongress@zs-hospital.sh.cn |
| United States, Maryland | |
| National Cancer Institute, NIH, US | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: Xin Wei Wang, PhD wangx@intra.nci.nih.gov | |
| Principal Investigator: Xin Wei Wang, PhD | |
| China, Beijing | |
| Peking Union Medical College Hospital | Recruiting |
| Beijing, Beijing, China | |
| Contact: Hai-Tao Zhao, MD zhaoht@yahoo.cn | |
| Principal Investigator: Yi-Lei Mao, MD | |
| Sub-Investigator: Hai-Tao Zhao, MD | |
| China, Fujian | |
| Fujian Tumor Hospital | Recruiting |
| Fuzhou, Fujian, China | |
| Contact: Dong Zhou, MD | |
| Principal Investigator: Min-Gang Ying, MD | |
| Sub-Investigator: Dong Zhou, MD | |
| The Mengchao hepatobiliary hospital,Fujian Medical University,and Liver disease research center of Fujian province | Recruiting |
| Fuzhou, Fujian, China | |
| Contact: Jingfeng Liu drjingfeng@yahoo.com.cn | |
| Principal Investigator: Jingfeng Liu | |
| China, Guangdong | |
| Tumor Hospital, Sun Yat-Sen University | Recruiting |
| Guangzhou, Guangdong, China, 510060 | |
| Contact: Li Xu, MD xuli@sysucc.org.cn | |
| Principal Investigator: Min-Shan Chen, MD | |
| Sub-Investigator: Li Xu, MD | |
| China, Shanghai | |
| Eastern Hepatobiliary Surgery Hospital, the Chinese Second Military Medical University | Recruiting |
| Shanghai, Shanghai, China | |
| Contact: Feng Shen, MD, PhD shenfengdfgd@yahoo.com.cn | |
| Contact: Feng Shen, MD, PhD shenfengdfgd@yahoo.com | |
| Principal Investigator: Feng Shen, MD, PhD | |
| China, Tianjin | |
| Tumor Hospital, Tianjin Medical University | Recruiting |
| Tianjin, Tianjin, China | |
| Contact: Ti Zhang, MD zhangti2001@yahoo.com.cn | |
| Principal Investigator: Qiang Li, MD | |
| Sub-Investigator: Ti Zhang, MD | |
| China | |
| Liver Cancer Institute and Zhongshan Hospital, Fudan University | Recruiting |
| Shanghai, China, 200032 | |
| Contact: Mei-ling Li 64041990 ext 2936 livercongress@zs-hospital.sh.cn | |
| Principal Investigator: Jia Fan, MD | |
| Sub-Investigator: Hui-Chuan Sun, MD | |
| ShanghaiBio Coorperation | Recruiting |
| Shanghai, China | |
| Contact: Jason Gang Jin, PhD 13818588366 jasongjin@gmail.com | |
| Principal Investigator: Jason Gang Jin, MD, PhD | |
| Principal Investigator: | Jia Fan, MD, PHD | Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China |
More Information
Publications:
| Responsible Party: | Jia Fan, Professor of Surgery, Fudan University |
| ClinicalTrials.gov Identifier: | NCT01681446 History of Changes |
| Other Study ID Numbers: | LCI IFNa miR-26 |
| Study First Received: | August 23, 2012 |
| Last Updated: | April 1, 2013 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Fudan University:
|
hepatocellular carcinoma interferon-alpha miR-26 |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Interferon-alpha Interferon Alfa-2a |
Interferons Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013