The Effect of Postoperative Interferon- Alpha Treatment in Low miR-26 Expression Patients With HCC

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Jia Fan, Fudan University
ClinicalTrials.gov Identifier:
NCT01681446
First received: August 23, 2012
Last updated: August 5, 2014
Last verified: August 2014
  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.

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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:
  • Recombinant Human Interferon α1b for Injection
  • SINOGEN
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
Criteria

Perioperative Period Inclusion Criteria:

  1. Signed informed consent;
  2. Aged ≥ 18 years and ≤ 75 years old, male or female;
  3. Patients with low miR-26 expression(confirmed by RT-PCR) underwent a curative resection of HCC;
  4. The tumor characteristics must meet the following:

    1. tumor diameter is between 3 to 8 centimeters,and the number of tumor is less tnan 3
    2. no thrombosis is detected in the main branches of the portal vein, hepatic vein and bile duct
    3. no extrahepatic and lymphnode metastasis

Perioperative Period Exclusion Criteria:

  1. Concomitant malignant primary tumor(s) in other systems is/are present;
  2. 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;
  3. The subject takes other study/investigational drugs during this study;
  4. The subject has cerebrovascular accident, renal insufficiency, depression, hyperthyreosis, hypothyroidism or other severe uncontrolled diseases;
  5. The subject has a history of study drug or similar drug allergy.

Baseline (Post-SurgeryDay 25 ± 5) Inclusion Criteria:

  1. Baseline (post-resection) blood routine examination shows that the number of leukocyte>2.5*10^9/L and platelet count>40*10^9/L;
  2. Child-Pugh score of class A at baseline.

Baseline (Post-SurgeryDay 25 ± 5) Exclusion Criteria:

  1. Concomitant malignant primary tumor(s) in other systems is/are present;
  2. The subject takes other study/investigational drugs within 4 weeks prior to randomization;
  3. The baseline examination indicates that infection, bleeding, bile leakage, or other postoperative complications are present;
  4. The baseline examination suggests the presence of tumor metastasis;
  5. The subject has cerebrovascular accident, renal insufficiency, depression, hyperthyreosis, hypothyroidism or other severe uncontrolled diseases;
  6. The subject has a history of investigational drug or similar drug allergy;
  7. The subject is pregnant, lactating, or urine pregnancy test result is positive.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681446

Contacts
Contact: Mei-ling Li 64041990 ext 2936 livercongress@zs-hospital.sh.cn

Locations
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
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         
Fujian Tumor Hospital Recruiting
Fuzhou, Fujian, China
Contact: Dong Zhou, MD         
Principal Investigator: Min-Gang Ying, MD         
Sub-Investigator: Dong Zhou, MD         
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
ShanghaiBio Coorperation Recruiting
Shanghai, China
Contact: Jason Gang Jin, PhD    13818588366    jasongjin@gmail.com   
Principal Investigator: Jason Gang Jin, MD, PhD         
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         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Jia Fan, MD, PHD Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China
Principal Investigator: Xin Wei Wang, PhD National Cancer Institute, NIH, US
  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: August 5, 2014
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
hepatocellular carcinoma
interferon-alpha
miR-26

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Interferons
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014