Overview

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

Status:
Unknown status

Trial end date:
2019-08-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Fudan University

Treatments:

Interferon-alpha
Interferons

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.