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

May 30, 2018 updated by: Jia Fan, Fudan University

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

296

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • The Mengchao hepatobiliary hospital，Fujian Medical University，and Liver disease research center of Fujian province
        • Contact:
        • Principal Investigator:
          • Jingfeng Liu
      • Xiamen, Fujian, China, 361004
        • Recruiting
        • Zhongshan Hospital, Xiamen University
        • Contact:
          • Ping-Guo Liu, MD
        • Principal Investigator:
          • Ping-Guo Liu, MD
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Liver Cancer Institute and Zhongshan Hospital, Fudan University
        • Contact:
        • Sub-Investigator:
          • Hui-Chuan Sun, MD
      • Shanghai, Shanghai, China
        • Recruiting
        • ShanghaiBio Coorperation
        • Contact:
        • Principal Investigator:
          • Jason Gang Jin, MD, PhD
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tumor Hospital, Tianjin Medical University
        • Principal Investigator:
          • Qiang Li, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

August 23, 2012

First Submitted That Met QC Criteria

September 5, 2012

First Posted (Estimate)

September 10, 2012

Study Record Updates

Last Update Posted (Actual)

June 1, 2018

Last Update Submitted That Met QC Criteria

May 30, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCI IFNa miR-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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