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The Effect of Postoperative Interferon- Alpha Treatment in Low miR-26 Expression Patients With Hepatocellular Carcinoma: a Muti-center Randomized Clinical Trail.


N/A
18 Years
75 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

The Effect of Postoperative Interferon- Alpha Treatment in Low miR-26 Expression Patients With Hepatocellular Carcinoma: a Muti-center Randomized Clinical Trail.


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease free survival

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Jia Fan, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China

Authority:

China: Ethics Committee

Study ID:

LCI IFNa miR-26

NCT ID:

NCT01681446

Start Date:

August 2012

Completion Date:

February 2015

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatocellular carcinoma
  • interferon-alpha
  • miR-26
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

National Cancer Institute, NIH, USBethesda, Maryland  20892