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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
anti-HBV
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGIncidence 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
Time frame: through study completion, an average of 1 year
The 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.
Time frame: 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.
Time frame: through study completion, an average of 1 year
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