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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Drug: Entecavir


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prophylactic Entecavir<br>Entecavir is prophylactically used from the time of chemotherapy initiation at the dose of 0.5 mg p.o daily | Drug: Entecavir<br>* anti hepatitis B virus<br>* Other names: Entecavir Dispersible Tablets;|
| Active Comparator: Preemptive Entecavir<br>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<br>* anti hepatitis B virus<br>* Other names: Entecavir Dispersible Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | through study completion, an average of 1 year | 
| 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. | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, Entecavir, Hepatitis B Carrier