The Investigation of Peginterferon Alfa-2a on the RFS of the Subjects With HCC Who Have Been Treated by Resection
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 4
Contacts and Locations
Study Contact
Study Contact
- Name: Lunxiu Qin
- Phone Number: 52887172
- Email: qinlx@fudan.edu.cn
Study Contact Backup
- Name: Huliang Jia
- Email: jbl-1@163.com
Study Locations
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-
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Shanghai, China
- Recruiting
- Huashan Hospital
-
Contact:
- Lunxiu Qin
- Phone Number: 52887172
- Email: qinlx@fudan.edu.cn
-
Contact:
- Huliang Jia
- Email: jbl-1@163.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female patients with age ≥18 and ≤70 years;
- Expected survival time >3 months;
- 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;
- The patients have been treated by resection due to HCC;
- The characteristic of tumor should be:Barcelona Clinic Liver Cancer(BCLC): 0,A,B
- Child-Pugh scores:A
- Agree to participate in the study and sign the patient informed consent form.
Exclusion Criteria:
- Patients that have been treated by live transplantation、chemoembolization、radiotherapy、chemotherapy、molecular targeted therapy and biotherapy before the resection;
- Patients that are treated by hepatotoxicity drugs 、immunosuppressant or adjuvant chemotherapy after the resection;
- Patients who be treated by transcatheter arterial chemoembolization(TACE) after resection;
- BCLC(Barcelona Clinic Liver Cancer):C、D before the resection;
- History or other evidence of malignant tumor: except by basal cell carcinoma or squamous cell carcinoma which are cured 、carcinoma in situs of cervix
- Allergic history to interferon;
- Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV);
- 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);
- absolute neutrophil count(ANC)<1.5x 10^9/L or platelet count(PLT)<70x 10^9/L
- Creatinine over upper limit of normal;
- 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;
- 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);
- History of thyroid disease poorly controlled on prescribed medications;
- Evidence of severe retinopathy or clinically relevant ophthalmologic disorder;
- 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;
- Evidence of postoperative complications: infectious、bleeding, etc,. at baseline; or evidence of recurrence or metastasis at baseline;
- Child-Pugh scores :B、C
- Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening;
- Other disease should exclusive considered by the investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
|
NAs
Other Names:
|
|
Experimental: Group B
The subjects will be treated by peginterferon alfa-2a (135μg/week)combination with NAs(ETV\TDF\ADV) for 96 weeks.
|
NAs
Other Names:
peginterferon
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recurrence-free Survival Rate (RFS)
Time Frame: 2 years
|
Number of subjects without Recurrence in the total subjects
|
2 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recurrence-free Survival Rate (RFS)
Time Frame: 1 year
|
Number of subjects without Recurrence in the total subjects
|
1 year
|
|
Overall Survival Rate (OS)
Time Frame: 2 years
|
Number of subjects with survival in the total subjects
|
2 years
|
|
Overall Survival Rate (OS)
Time Frame: 1 year
|
Number of subjects with survival in the total subjects
|
1 year
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Lunxiu Qin, Huashan Hospital
- Principal Investigator: Jimimg Zhang, Huashan Hospital
Publications and helpful links
General Publications
- Sun HC, Tang ZY, Wang L, Qin LX, Ma ZC, Ye QH, Zhang BH, Qian YB, Wu ZQ, Fan J, Zhou XD, Zhou J, Qiu SJ, Shen YF. Postoperative interferon alpha treatment postponed recurrence and improved overall survival in patients after curative resection of HBV-related hepatocellular carcinoma: a randomized clinical trial. J Cancer Res Clin Oncol. 2006 Jul;132(7):458-65. doi: 10.1007/s00432-006-0091-y. Epub 2006 Mar 24.
- Sohn W, Paik YH, Kim JM, Kwon CH, Joh JW, Cho JY, Gwak GY, Choi MS, Lee JH, Koh KC, Paik SW, Yoo BC. HBV DNA and HBsAg levels as risk predictors of early and late recurrence after curative resection of HBV-related hepatocellular carcinoma. Ann Surg Oncol. 2014 Jul;21(7):2429-35. doi: 10.1245/s10434-014-3621-x. Epub 2014 Mar 12.
- Micco L, Peppa D, Loggi E, Schurich A, Jefferson L, Cursaro C, Panno AM, Bernardi M, Brander C, Bihl F, Andreone P, Maini MK. Differential boosting of innate and adaptive antiviral responses during pegylated-interferon-alpha therapy of chronic hepatitis B. J Hepatol. 2013 Feb;58(2):225-33. doi: 10.1016/j.jhep.2012.09.029. Epub 2012 Oct 6.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Liver Neoplasms
- Hepatitis, Chronic
- Hepatitis
- Carcinoma
- Hepatitis B
- Carcinoma, Hepatocellular
- Hepatitis B, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
- Peginterferon alfa-2a
- Entecavir
- Adefovir
Other Study ID Numbers
Other Study ID Numbers
- PEG-HCC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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