Clinical trial · Interventional

Effects of Antiviral Therapy on HBV Reactivation

Effects of Antiviral Therapy on HBV Reactivation and Liver Function After Hepatectomy for HBV-DNA Negative HBV-related Hepatocellular Carcinoma

NCT02829359CI-TRIAL-00028072HBV-DNA(-)completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Hepatitis B virus (HBV) reactivation happens after liver resection for HBV-related hepatocellular carcinoma (HCC) patients, particularly for those with positive serum HBV-DNA . The incidence rate and risk factors of HBV reactivation after hepatectomy for serum HBV-DNA negative HBV-related HCC are unclear.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Liver Cancer	Malignant Liver Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Entecavir therapy	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Entecavir therapy
description
Patients who received entecavir (zhengda Tianqing Co., Ltd, Lianyungang, Jiangsu Province, China; 0.5 mg/d) were submitted to antiviral group. Patients in the antiviral group received entecavir begin in the first 3 days before surgery for at lest 1 month. No immunological therapy in perioperative period will be submitted to any included patients.
interventionNames
1. Drug: Entecavir therapy
type
NO_INTERVENTION
label
No antiviral therapy
description
Patients who did not receive any antiviral therapies were submitted as non-antiviral group. Patients in the non-antiviral group who underwent HBV reactivation will receive entecavir therapy. No immunological therapy in perioperative period will be submitted to any included patients.

Primary outcomes (2)

measure
Rate of HBV reactivation

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

Inclusion Criteria:

* underwent initial hepatectomy;
* preoperative serum HBsAg positive
* serum HBV DNA negative
* serum ALT in normal range
* Child-Pugh A liver function
* HCC was confirmed by histopathology
* patients in the treated group received Entecavir (ENT) while patients in the control group did not receive any antiviral therapy.

Exclusion Criteria:

* underwent preoperative TACE or other anti-tumor treatments
* underwent preoperative antiviral treatment for nearly a year
* with autoimmune disease, other organ malignant tumor, or other severe disease.

References

Publications (7)

BACKGROUNDLi X, Zhong X, Chen ZH, Wang TT, Ma XK, Xing YF, Wu DH, Dong M, Chen J, Ruan DY, Lin ZX, Wen JY, Wei L, Wu XY, Lin Q. Efficacy of Prophylactic Entecavir for Hepatitis B Virus-Related Hepatocellular Carcinoma Receiving Transcatheter Arterial Chemoembolization. Asian Pac J Cancer Prev. 2015;16(18):8665-70. doi: 10.7314/apjcp.2015.16.18.8665. PMID 26745134
BACKGROUNDXie ZB, Zhu SL, Peng YC, Chen J, Wang XB, Ma L, Bai T, Xiang BD, Li LQ, Zhong JH. Postoperative hepatitis B virus reactivation and surgery-induced immunosuppression in patients with hepatitis B-related hepatocellular carcinoma. J Surg Oncol. 2015 Nov;112(6):634-42. doi: 10.1002/jso.24044. Epub 2015 Sep 30. PMID 26421419
BACKGROUNDJang JW, Kim YW, Lee SW, Kwon JH, Nam SW, Bae SH, Choi JY, Yoon SK, Chung KW. Reactivation of hepatitis B virus in HBsAg-negative patients with hepatocellular carcinoma. PLoS One. 2015 Apr 20;10(3):e0122041. doi: 10.1371/journal.pone.0122041. eCollection 2015. PMID 25894607
BACKGROUNDSohn W, Paik YH, Cho JY, Ahn JM, Choi GS, Kim JM, Kwon CH, Joh JW, Sinn DH, Gwak GY, Choi MS, Lee JH, Koh KC, Paik SW, Yoo BC. Influence of hepatitis B virus reactivation on the recurrence of HBV-related hepatocellular carcinoma after curative resection in patients with low viral load. J Viral Hepat. 2015 Jun;22(6):539-50. doi: 10.1111/jvh.12356. Epub 2014 Nov 7. PMID 25377516
BACKGROUNDLee JI, Kim JK, Chang HY, Lee JW, Kim JM, Chung HJ, Kim YS, Lee KS. Impact of postoperative hepatitis B virus reactivation in hepatocellular carcinoma patients who formerly had naturally suppressed virus. J Gastroenterol Hepatol. 2014 May;29(5):1019-27. doi: 10.1111/jgh.12472. PMID 24325315
BACKGROUNDHuang L, Li J, Yan J, Sun J, Zhang X, Wu M, Yan Y. Antiviral therapy decreases viral reactivation in patients with hepatitis B virus-related hepatocellular carcinoma undergoing hepatectomy: a randomized controlled trial. J Viral Hepat. 2013 May;20(5):336-42. doi: 10.1111/jvh.12036. Epub 2012 Dec 5.