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

Chronic Hepatitis b Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03253250
• Other study ID #: PEG-HCC
• Status: Recruiting
• Phase: Phase 4
• First received: August 15, 2017
• Last updated: September 6, 2017
• Start date: September 1, 2017
• Est. completion date: December 2019

Study information

• Verified date: September 2017
• Source: Huashan Hospital
• Contact: Lunxiu Qin
• Phone: 52887172
• Email: qinlx[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 432
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Chronic Hepatitis b
• Hepatic Carcinoma
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• ETV;TDF;ADV
NAs
• Peginterferon Alfa-2a
peginterferon

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Epub 2006 Mar 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free Survival Rate (RFS)	Number of subjects without Recurrence in the total subjects	2 years
Secondary	Recurrence-free Survival Rate (RFS)	Number of subjects without Recurrence in the total subjects	1 year
Secondary	Overall Survival Rate (OS)	Number of subjects with survival in the total subjects	2 years
Secondary	Overall Survival Rate (OS)	Number of subjects with survival in the total subjects	1 year