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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03253250
Recruitment Status : Unknown
Verified September 2017 by Jiming Zhang, Huashan Hospital.
Recruitment status was:  Recruiting
First Posted : August 17, 2017
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
Jiming Zhang, Huashan Hospital

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis b Hepatic Carcinoma Drug: ETV;TDF;ADV Drug: Peginterferon Alfa-2a Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multicenter, Open-label, Exploratory Study of Utilizing of Peginterferon Alfa-2a on the Relapse Rate of the Subjects With Hepatocellular Carcinoma Who Have Been Treated by Resection
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
The subjects will be treated by NAs (ETV, 0.5mg,qd;TDF,300mg,qd;ADV,10mg,qd)for 96 weeks
Drug: ETV;TDF;ADV
NAs
Other Name: entecavir;tenofovir disoproxil fumarate;adefovir

Experimental: Group B
The subjects will be treated by peginterferon alfa-2a (135μg/week)combination with NAs(ETV\TDF\ADV) for 96 weeks.
Drug: ETV;TDF;ADV
NAs
Other Name: entecavir;tenofovir disoproxil fumarate;adefovir

Drug: Peginterferon Alfa-2a
peginterferon
Other Name: pegasys




Primary Outcome Measures :
  1. Recurrence-free Survival Rate (RFS) [ Time Frame: 2 years ]
    Number of subjects without Recurrence in the total subjects


Secondary Outcome Measures :
  1. Recurrence-free Survival Rate (RFS) [ Time Frame: 1 year ]
    Number of subjects without Recurrence in the total subjects

  2. Overall Survival Rate (OS) [ Time Frame: 2 years ]
    Number of subjects with survival in the total subjects

  3. Overall Survival Rate (OS) [ Time Frame: 1 year ]
    Number of subjects with survival in the total subjects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253250


Contacts
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Contact: Lunxiu Qin 52887172 qinlx@fudan.edu.cn
Contact: Huliang Jia jbl-1@163.com

Locations
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China
Huashan Hospital Recruiting
Shanghai, China
Contact: Lunxiu Qin    52887172    qinlx@fudan.edu.cn   
Contact: Huliang Jia       jbl-1@163.com   
Sponsors and Collaborators
Huashan Hospital
Investigators
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Principal Investigator: Lunxiu Qin Huashan Hospital
Principal Investigator: Jimimg Zhang Huashan Hospital
Publications:
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Responsible Party: Jiming Zhang, Deputy director of department, Huashan Hospital
ClinicalTrials.gov Identifier: NCT03253250    
Other Study ID Numbers: PEG-HCC
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis, Chronic
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Tenofovir
Peginterferon alfa-2a
Entecavir
Adefovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents