The Investigation of Peginterferon Alfa-2a on the RFS of the Subjects With HCC Who Have Been Treated by Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

432 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-12-31

Brief Summary

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The current study is a prospective, randomized, open, multi-center investigation. The aim of current study is to investigate whether the Recurrence-free Survival Rate (RFS）of the hepatitis B related -hepatocellular carcinoma subjects who have been treated by resection can be improved by peginterferon alfa-2a

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A Study of Capecitabine (Xeloda) and Peginterferon Alfa-2a (Pegasys) in Treatment-Naive Participants With Advanced Liver Cancer

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Detailed Description

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The subjects who have been treated by resection due to hepatocellular carcinoma (HCC) will be randomized into 2 groups: the subjects in group A will be treated by Nucleotide analogues (NAs)( ETV, 0.5mg，qd；tenofovir disoproxil fumarate(TDF)，300mg，qd；ADV，10mg，qd）for 96 weeks; the subjects in group B will be treated by peginterferon alfa-2a （135μg/week）combination with NAs (ETV\\TDF\\ADV)for 96 weeks.

Conditions

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Chronic Hepatitis b Hepatic Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

The subjects will be treated by NAs (ETV, 0.5mg，qd；TDF，300mg，qd；ADV，10mg，qd）for 96 weeks

Group Type ACTIVE_COMPARATOR

ETV；TDF；ADV

Intervention Type DRUG

NAs

Group B

The subjects will be treated by peginterferon alfa-2a （135μg/week）combination with NAs(ETV\\TDF\\ADV) for 96 weeks.

Group Type EXPERIMENTAL

ETV；TDF；ADV

Intervention Type DRUG

NAs

Peginterferon Alfa-2a

Intervention Type DRUG

peginterferon

Interventions

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ETV；TDF；ADV

NAs

Intervention Type DRUG

Peginterferon Alfa-2a

peginterferon

Intervention Type DRUG

Other Intervention Names

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entecavir;tenofovir disoproxil fumarate;adefovir pegasys

Eligibility Criteria

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Inclusion Criteria

1. Male and female patients with age ≥18 and ≤70 years;
2. Expected survival time \>3 months;
3. There should be evidences that chronic hepatitis B or hepatitis have been positive, hepatitis B virus (HBV) DNA detectable or undetectable, Alanine aminotransferase(ALT)\<upper limit of normal (ULN) or ≥ULN；
4. The patients have been treated by resection due to HCC;
5. The characteristic of tumor should be:Barcelona Clinic Liver Cancer(BCLC): 0,A,B
6. Child-Pugh scores:A
7. Agree to participate in the study and sign the patient informed consent form.

Exclusion Criteria

1. Patients that have been treated by live transplantation、chemoembolization、radiotherapy、chemotherapy、molecular targeted therapy and biotherapy before the resection;
2. Patients that are treated by hepatotoxicity drugs 、immunosuppressant or adjuvant chemotherapy after the resection;
3. Patients who be treated by transcatheter arterial chemoembolization(TACE) after resection;
4. BCLC(Barcelona Clinic Liver Cancer):C、D before the resection;
5. History or other evidence of malignant tumor: except by basal cell carcinoma or squamous cell carcinoma which are cured 、carcinoma in situs of cervix
6. Allergic history to interferon;
7. Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV);
8. History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia);
9. absolute neutrophil count(ANC)\<1.5x 10\^9/L or platelet count(PLT)\<70x 10\^9/L
10. Creatinine over upper limit of normal;
11. History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as major depression or psychosis that treated with antidepressant medication or a major tranquilizer at therapeutic doses respectively at any time prior to 3 months or any history of the following: a suicidal attempt hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease;
12. History of severe cardiac disease (e.g., New York Heart Association Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases);
13. History of thyroid disease poorly controlled on prescribed medications;
14. Evidence of severe retinopathy or clinically relevant ophthalmologic disorder;
15. History of other severe disease or evidence of other severe disease or any other illness or conditions that the investigator believe that patients are not suitable to join in the study;
16. Evidence of postoperative complications: infectious、bleeding, etc,. at baseline; or evidence of recurrence or metastasis at baseline;
17. Child-Pugh scores :B、C
18. Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening;
19. Other disease should exclusive considered by the investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No