NCT02777814

Brief Summary

There has been no report on whether the patients with colorectal cancer who are also inactive Hepatitis B Carriers should receive Prophylactic Use or preemptive Use of an Anti-viral Drug Entecavir. This open, randomized controlled clinical trial aims to compare the impact of the prophylactic use or preemptive use of an anti-viral drug Entecavir on the outcomes of patients with colorectal cancer who are also inactive hepatitis B carriers during chemotherapy and the subsequent follow-ups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

3.4 years

First QC Date

April 1, 2016

Last Update Submit

January 17, 2019

Conditions

Colorectal Neoplasms

Keywords

colorectal cancerEntecavirHepatitis B Carrier

Outcome Measures

Primary Outcomes (1)

  • Incidence of hepatitis B virus associated hepatitis

    Hepatitis is defined as a 3-fold or greater increase in the serum ALT level that exceeded the reference range (\>58U/L) or an absolute increase in the level of ALT of greater than 100 U/L compared with the baseline level

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • Incidence of hepatitis B virus reactivation

    through study completion, an average of 1 year

  • Interruption of chemotherapy due to hepatitis

    through study completion, an average of 1 year

Study Arms (2)

Prophylactic Entecavir

EXPERIMENTAL

Entecavir is prophylactically used from the time of chemotherapy initiation at the dose of 0.5 mg p.o daily

Drug: Entecavir

Preemptive Entecavir

ACTIVE COMPARATOR

Entecavir is preemptively used from the time that hepatitis B virus DNA copies are more than 100 IU/ml at the dose of 0.5 mg p.o daily

Drug: Entecavir

Interventions

EntecavirDRUG

anti hepatitis B virus

Also known as: Entecavir Dispersible Tablets
Preemptive EntecavirProphylactic Entecavir

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with age between 18 and 75
  • Patient with histology-proven colorectal adenocarcinoma.
  • Patients with Eastern Cooperative Oncology Group performance status (ECOG) of 0-1
  • Patients planned for at least 4 cycles of cytotoxic chemotherapy (either as part of curative therapy or as palliative therapy)
  • Patients with at least 6 months' life expectancy from date of recruitment
  • Patients with positive Hepatitis B Surface-antigen (HBsAg)
  • Patients with normal liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase alkaline (AST), phosphatase (ALP), gamma glutamyl-transpeptidase (GGT), and bilirubin
  • Patients with negative HBV-DNA
  • Patients with no known history of radiological \&/or histological diagnosis of chronic active hepatitis or cirrhosis of any cause, or history of prior hepatitis B reactivation, or prior chronic therapy for HBV within 6 months
  • Patients with no evidence of autoimmune hepatitis, hepatitis C or D virus infection, HIV infection or radiological evidence of liver metastasis
  • adequate bone marrow, hepatic, and renal function within 14 days before recruitment
  • patients who sign the informed consent
  • Patients with good compliance during chemotherapy and follow-ups

You may not qualify if:

  • Patients planned for radiation or radionuclide therapy
  • Pregnant female patients
  • Patients with a history of psychiatric drugs abuse and can't quit or with a mental disorder
  • Patients with immunodeficiency, other congenital or acquired immunodeficiency, or transplantation history
  • According to the investigators' judgment, patients with concomitant disease that seriously harms patients' safety or the completion of study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (3)

  • Di Bisceglie AM, Lok AS, Martin P, Terrault N, Perrillo RP, Hoofnagle JH. Recent US Food and Drug Administration warnings on hepatitis B reactivation with immune-suppressing and anticancer drugs: just the tip of the iceberg? Hepatology. 2015 Feb;61(2):703-11. doi: 10.1002/hep.27609.

    PMID: 25412906BACKGROUND

  • Huang H, Li X, Zhu J, Ye S, Zhang H, Wang W, Wu X, Peng J, Xu B, Lin Y, Cao Y, Li H, Lin S, Liu Q, Lin T. Entecavir vs lamivudine for prevention of hepatitis B virus reactivation among patients with untreated diffuse large B-cell lymphoma receiving R-CHOP chemotherapy: a randomized clinical trial. JAMA. 2014 Dec 17;312(23):2521-30. doi: 10.1001/jama.2014.15704.

    PMID: 25514302RESULT

  • Perrillo RP, Gish R, Falck-Ytter YT. American Gastroenterological Association Institute technical review on prevention and treatment of hepatitis B virus reactivation during immunosuppressive drug therapy. Gastroenterology. 2015 Jan;148(1):221-244.e3. doi: 10.1053/j.gastro.2014.10.038. Epub 2014 Oct 31. No abstract available.

    PMID: 25447852RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

entecavir

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Rui-hua Xu, M.D. Ph.D.

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui-hua Xu, M.D. Ph.D.

CONTACT

+86-20-87343295xurh@sysucc.org.cn

Feng Wang, M.D. Ph.D.

CONTACT

+86-18620880867fengwang@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 1, 2016

First Posted

May 19, 2016

Study Start

May 1, 2015

Primary Completion

October 1, 2018

Study Completion

November 1, 2019

Last Updated

January 22, 2019

Record last verified: 2019-01

Locations

CN(1)