drugset / Trial / NCT03253250
The Investigation of Peginterferon Alfa-2a on the RFS of the Subjects With HCC Who Have Been Treated by Resection
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2017-09-01
- Primary completion
- 2019-06
- Completion
- 2019-12
Publications
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | 135 ug | — |
| Background | ADV | Unknown | 10 mg | — |
| Background | ETV | Unknown | 0.5 mg | — |
| Background | TDF | Unknown | 300 mg | — |