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Prophylactic or Preemptive Entecavir in Patients With Colorectal Cancer Who Are Inactive Hepatitis B Carriers

Primary Purpose

Colorectal Neoplasms

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Entecavir

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring colorectal cancer, Entecavir, Hepatitis B Carrier

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prophylactic Entecavir

Preemptive Entecavir

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of hepatitis B virus reactivation

Reactivation of HBV is defined as a 10-fold or greater increase in the HBV DNA level or an absolute increase of 10^5 copies/mL or greater compared with the baseline value.

Interruption of chemotherapy due to hepatitis

Chemotherapy disruption is defined as either premature termination or a delay of at least 7 days between chemotherapy cycles.

Full Information

NCT ID

NCT02777814

First Posted

April 1, 2016

Last Updated

January 17, 2019

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02777814

Brief Title

Prophylactic or Preemptive Entecavir in Patients With Colorectal Cancer Who Are Inactive Hepatitis B Carriers

Official Title

An Open, Randomized Controlled Clinical Trial to Compare the Prophylactic Use or Preemptive Use of an Anti-viral Drug Entecavir in Patients With Colorectal Cancer Who Are Inactive Hepatitis B Carriers

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2015 (Actual)

Primary Completion Date

October 2018 (Actual)

Study Completion Date

November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasms

Keywords

colorectal cancer, Entecavir, Hepatitis B Carrier

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prophylactic Entecavir

Arm Type

Experimental

Arm Description

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

Arm Title

Preemptive Entecavir

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Entecavir

Other Intervention Name(s)

Entecavir Dispersible Tablets

Intervention Description

anti hepatitis B virus

Primary Outcome Measure Information:

Title

Incidence of hepatitis B virus associated hepatitis

Description

Time Frame

through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

Incidence of hepatitis B virus reactivation

Description

Reactivation of HBV is defined as a 10-fold or greater increase in the HBV DNA level or an absolute increase of 10^5 copies/mL or greater compared with the baseline value.

Time Frame

through study completion, an average of 1 year

Title

Interruption of chemotherapy due to hepatitis

Description

Chemotherapy disruption is defined as either premature termination or a delay of at least 7 days between chemotherapy cycles.

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

+86-20-87343295

xurh@sysucc.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Feng Wang, M.D. Ph.D.

Phone

+86-18620880867

fengwang@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Feng Wang

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25412906

Citation

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.

Results Reference

background

PubMed Identifier

25514302

Citation

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.

Results Reference

result

PubMed Identifier

25447852

Citation

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.

Results Reference

result

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Prophylactic or Preemptive Entecavir in Patients With Colorectal Cancer Who Are Inactive Hepatitis B Carriers

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