Prophylactic or Preemptive Entecavir in Patients With Colorectal Cancer Who Are Inactive Hepatitis B Carriers
- Registration Number
- NCT02777814
- Lead Sponsor
- Sun Yat-sen University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prophylactic Entecavir Entecavir Entecavir is prophylactically used from the time of chemotherapy initiation at the dose of 0.5 mg p.o daily Preemptive Entecavir 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
- Primary Outcome Measures
Name Time Method Incidence of hepatitis B virus associated hepatitis 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
- Secondary Outcome Measures
Name Time Method Incidence of hepatitis B virus reactivation 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.
Interruption of chemotherapy due to hepatitis 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.
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China