An Open, Randomized Controlled Clinical Trial to Compare the Prophylactic Use or Preemptive Use of an Anti-viral Drug Entecavir in Patients With Gastric Cancer Who Are Inactive Hepatitis B Carriers
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Incidence of hepatitis B virus associated hepatitis
Study Overview
Brief Summary
There has been no report on whether the patients with gastric 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 gastric cancer who are also inactive hepatitis B carriers during chemotherapy and the subsequent follow-ups.
Detailed Description
Patients with gastric cancer who are also inactive hepatitis B carriers are enrolled and randomized into two groups as following. Patients in experimental group are treated with entecavir prophylactically in the dose of 0.5mg p.o. every day from the initiation of chemotherapy till 6 months after the end of chemotherapy.Patients in active comparator group are only treated with entecavir in the dose of 0.5mg p.o. every day from the time that the DNA copies of hepatitis B virus are more than 100 IU/ml till 6 months after the end of chemotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with age between 18 and 75
- •Patient with histology-proven gastric 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.
Arms & Interventions
Prophylactic Entecavir
use of entecavir in the dose of 0.5mg p.o. every day from the initiation of chemotherapy till 6 months after the end of chemotherapy.
Intervention: Entecavir (Drug)
Preemptive Entecavir
use of entecavir in the dose of 0.5mg p.o. every day from the time that the DNA copies of hepatitis B virus are more than 100 IU/ml till 6 months after the end of chemotherapy.
Intervention: Entecavir (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- The 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)
Investigators
Ruihua Xu
Prof
Sun Yat-sen University