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Trial record 1 of 1 for:    NCT01681446
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Adjuvant IFN-α for Patients Underwent Curative Surgery for HCC With a Low miR-26 Expression

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ClinicalTrials.gov Identifier: NCT01681446
Recruitment Status : Unknown
Verified May 2018 by Jia Fan, Fudan University.
Recruitment status was:  Recruiting
First Posted : September 10, 2012
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Jia Fan, Fudan University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: interferon-alpha (IFN-alpha) Phase 3

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : August 2012
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Drug: interferon-alpha (IFN-alpha)
interferon-alpha is intramuscular injected 30 μg three times a week or 50 μg twice a week for 18 months
Other Names:
  • Recombinant Human Interferon α1b for Injection
  • SINOGEN
No Intervention: control
no anti-cancer interventions were assigned


Outcome Measures
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Primary Outcome Measures :
  1. disease free survival [ Time Frame: 5 years ]
    interval between the dates of surgery and tumor recurrence or patient death


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]
    interval between the dates of surgery and patient death

  2. time to recurrence [ Time Frame: 5 years ]
    interval between the dates of surgery and tumor recurrence

  3. Number of Participants with Adverse Events [ Time Frame: eighteen months ]
    Number of Participants with Adverse Events（hypohepatia,fever,leukopenia and thrombopenia）will be measured


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 a low miR-26 expression in tumor (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 than 3
    2. 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
    3. no extrahepatic and lymph node 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, 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-Surgery 4 to 6 weeks) 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-Surgery 4 to 6 weeks) 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681446


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

Locations
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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         
Zhongshan Hospital, Xiamen University Recruiting
Xiamen, Fujian, China, 361004
Contact: Ping-Guo Liu, MD         
Principal Investigator: Ping-Guo Liu, MD         
China, Shanghai
Liver Cancer Institute and Zhongshan Hospital, Fudan University Recruiting
Shanghai, 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, Shanghai, China
Contact: Jason Gang Jin, PhD    13818588366    jasongjin@gmail.com   
Principal Investigator: Jason Gang Jin, 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         
Sponsors and Collaborators
Fudan University
Investigators
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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
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Publications:

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Responsible Party: Jia Fan, Professor of Surgery, Fudan University
ClinicalTrials.gov Identifier: NCT01681446    
Other Study ID Numbers: LCI IFNa miR-26
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Keywords provided by Jia Fan, Fudan University:
hepatocellular carcinoma
interferon-alpha
miR-26
Additional relevant MeSH terms:
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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
Interferons
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs