Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic Entecavir | Experimental | 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. |
|
| Preemptive Entecavir | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir | Drug | anti-HBV |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 1 year |
| Interruption of chemotherapy due to hepatitis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui-hua Xu, PHD,MD | Contact | +86 13922206676 | xurh@sysucc.org.cn | |
| Feng Wang, PHD,MD | Contact | +86 18620880867 | wangfeng@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Rui-hua Xu, PHD,MD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25514302 | Result | Huang H, Li X, Zhu J, Ye S, Zhang H, Wang W, Wu X, Peng J, Xu B, Lin Y, Cao Y, Li H, Lin S, Liu Q, Lin T. Entecavir vs lamivudine for prevention of hepatitis B virus reactivation among patients with untreated diffuse large B-cell lymphoma receiving R-CHOP chemotherapy: a randomized clinical trial. JAMA. 2014 Dec 17;312(23):2521-30. doi: 10.1001/jama.2014.15704. | |
| 25447852 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C413685 | entecavir |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Perrillo RP, Gish R, Falck-Ytter YT. American Gastroenterological Association Institute technical review on prevention and treatment of hepatitis B virus reactivation during immunosuppressive drug therapy. Gastroenterology. 2015 Jan;148(1):221-244.e3. doi: 10.1053/j.gastro.2014.10.038. Epub 2014 Oct 31. No abstract available. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |