- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02777814
Prophylactic or Preemptive Entecavir in Patients With Colorectal Cancer Who Are Inactive Hepatitis B Carriers
January 17, 2019 updated by: Ruihua Xu, Sun Yat-sen University
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
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-Sen University Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prophylactic Entecavir
Entecavir is prophylactically used from the time of chemotherapy initiation at the dose of 0.5 mg p.o daily
|
anti hepatitis B virus
Other Names:
|
Active Comparator: Preemptive Entecavir
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
|
anti hepatitis B virus
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of hepatitis B virus associated hepatitis
Time Frame: through study completion, an average of 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of hepatitis B virus reactivation
Time Frame: through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
Interruption of chemotherapy due to hepatitis
Time Frame: through study completion, an average of 1 year
|
Chemotherapy disruption is defined as either premature termination or a delay of at least 7 days between chemotherapy cycles.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rui-hua Xu, M.D. Ph.D., Sun Yat-sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2015
Primary Completion (Actual)
October 1, 2018
Study Completion (Anticipated)
November 1, 2019
Study Registration Dates
First Submitted
April 1, 2016
First Submitted That Met QC Criteria
May 17, 2016
First Posted (Estimate)
May 19, 2016
Study Record Updates
Last Update Posted (Actual)
January 22, 2019
Last Update Submitted That Met QC Criteria
January 17, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Liver Diseases
- Colonic Diseases
- Intestinal Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Intestinal Neoplasms
- Rectal Diseases
- Hepatitis B
- Hepatitis
- Colorectal Neoplasms
- Anti-Infective Agents
- Antiviral Agents
- Entecavir
Other Study ID Numbers
- CRC-HBV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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