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

Phase 3

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: interferon-alpha (IFN-alpha)

• Registration Number: NCT01681446
• Lead Sponsor: Fudan University

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.

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 Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-09-05
• Study First Posted: 2012-09-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-06-01
• Primary Completion: 2019-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 296

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
interferon-alpha (IFN-alpha)	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

Primary Outcome Measures

Name	Time	Method
disease free survival	5 years	interval between the dates of surgery and tumor recurrence or patient death

Secondary Outcome Measures

Name	Time	Method
overall survival	5 years	interval between the dates of surgery and patient death
time to recurrence	5 years	interval between the dates of surgery and tumor recurrence
Number of Participants with Adverse Events	eighteen months	Number of Participants with Adverse Events（hypohepatia,fever,leukopenia and thrombopenia）will be measured

Trial Locations

Locations (5)

The Mengchao hepatobiliary hospital，Fujian Medical University，and Liver disease research center of Fujian province; 🇨🇳 Fuzhou, Fujian, China

Zhongshan Hospital, Xiamen University; 🇨🇳 Xiamen, Fujian, China

Liver Cancer Institute and Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

ShanghaiBio Coorperation; 🇨🇳 Shanghai, Shanghai, China

Tumor Hospital, Tianjin Medical University; 🇨🇳 Tianjin, Tianjin, China