Stomach Neoplasms
Conditions
Keywords
gastric cancer, hepatitis B carrier, entecavir
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.
Interventions
DRUGEntecavir
anti-HBV
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with age between 18 and 75 2. Patient with histology-proven gastric adenocarcinoma. 3. Patients with Eastern Cooperative Oncology Group performance status (ECOG) of 0-1 4. Patients planned for at least 4 cycles of cytotoxic chemotherapy (either as part of curative therapy or as palliative therapy) 5. Patients with at least 6 months' life expectancy from date of recruitment 6. Patients with positive Hepatitis B Surface-antigen (HBsAg) 7. Patients with normal liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase alkaline (AST), phosphatase (ALP), gamma glutamyl-transpeptidase (GGT), and bilirubin 8. Patients with negative HBV-DNA 9. 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 10. Patients with no evidence of autoimmune hepatitis, hepatitis C or D virus infection, HIV infection or radiological evidence of liver metastasis 11. adequate bone marrow, hepatic, and renal function within 14 days before recruitment 12. patients who sign the informed consent 13. Patients with good compliance during chemotherapy and follow-ups
Exclusion criteria
1. Patients planned for radiation or radionuclide therapy 2. Pregnant female patients 3. Patients with a history of psychiatric drugs abuse and can't quit or with a mental disorder 4. Patients with immunodeficiency, other congenital or acquired immunodeficiency, or transplantation history 5. According to the investigators' judgment, patients with concomitant disease that seriously harms patients' safety or the completion of study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The 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. |
Countries
China
Contacts
Primary ContactRui-hua Xu, PHD,MD
Backup ContactFeng Wang, PHD,MD
Outcome results
None listed