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AzTrials

Liver CancerPhase 2/3HBV-DNA(-)NCT02829359

Effects of Antiviral Therapy on HBV Reactivation

A Phase 2/3 study testing Entecavir therapy in people with Liver Cancer, run by Guangxi Medical University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Liver Cancer
What is being tested?
Entecavir therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
Jul 2012to Dec 2015
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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

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.

Read the detailed description

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.From July 2012 to December 2015, 174 consecutive patients with serum HBV-DNA negative HBV-related HCC underwent resection were prospectively enrolled in the studied. There are 66 patients received preoperative antiviral therapy (antiviral group) and 108 patients did not receive any antiviral therapy (non-antiviral group). The incidence of HBV reactivation, risk factors of liver function were analyzed in perioperative period. HBV reactivation developed in 30 patients (27.8%) in the non- antiviral group and 2 patients (3.0%) in the antiviral group, respectively (P < 0.001). Multivariate analysis revealed that minor hepatectomy (HR, 4.695; 95% CI, 1.257-17.537, P = 0.021) and without antiviral therapy (HR, 8.164; 95% CI, 1.831-36.397, p =0.006) were risk factors attributed to HBV reactivation. Patients in antiviral group and non-antiviral group or reactivation group and without reactivation group have similar ALT, TBil, ALB, and PT in 7 days after resection. However, patients in antiviral group have significantly better ALT and ALB on day 30th after resection than those in control group. Moreover, similar phenomenon were observed when comparing those with or without HBV reactivation. Resection could lead to HBV reactivation during the perioperative period for serum HBV DNA negative HBV-related HCC, especially in patients who did not receive any antiviral therapy. Anti-HBV therapy can reduce the risk of reactivation, thus improving liver function after hepatectomy.

Conditions
Liver Cancer
Being tested
Entecavir therapy
Medical subject headings
Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Entecavir therapyDrug

    Patients in the antiviral group received entecavir begin in the first 3 days before surgery for at lest 1 month.

Study groups in NCT02829359
Study groupRoleWhat they receive
Entecavir therapyExperimentalPatients 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.
Receives: Drug: Entecavir therapy
No antiviral therapyNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of HBV reactivation

    Measured: 1 month after surgery

  2. HBV reactivation on the recovery of liver function

    Measured: 1 month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2016 (estimated)
  2. Study startJul 2012
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02829359
Sponsor's protocol ID
HBV-DNA(-)/HCC
Acronym
HBV-DNA(-)
Status last verified
Jul 2016
First submitted
8 Jul 2016
Last updated
12 Jun 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Li 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.

    PubMed 26745134

  • Xie 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.

    PubMed 26421419

  • Jang 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.

    PubMed 25894607

  • Sohn 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.

    PubMed 25377516

  • Lee 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.

    PubMed 24325315

  • Huang 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.

    PubMed 23565616

  • Lao XM, Luo G, Ye LT, Luo C, Shi M, Wang D, Guo R, Chen M, Li S, Lin X, Yuan Y. Effects of antiviral therapy on hepatitis B virus reactivation and liver function after resection or chemoembolization for hepatocellular carcinoma. Liver Int. 2013 Apr;33(4):595-604. doi: 10.1111/liv.12112. Epub 2013 Feb 13.

    PubMed 23402625

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Entecavir therapy in people with Liver Cancer, run by Guangxi Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of HBV reactivation (time frame: 1 month after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02829359, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.

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