Neoplasms

Digestive System Diseases

All Conditions

Infections

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Hepatitis A

Hepatitis

Hepatitis B

Liver Diseases

Gastrointestinal Diseases

Hepatitis, Viral, Human

Virus Diseases

Communicable Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Stomach Diseases

Blood-Borne Infections

Hepadnaviridae Infections

DNA Virus Infections

Stomach Cancer

Anti-Infective Agents

All Drugs and Chemicals

Antiviral Agents

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.

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.

Rui-hua Xu, PHD,MD

Feng Wang, PHD,MD

Feng Wang

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.

Prophylactic or Preemptive Entecavir in Patients With Gastric Cancer Who Are Inactive Hepatitis B Carriers

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

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

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.

Chemotherapy disruption is defined as either premature termination or a delay of at least 7 days between chemotherapy cycles.

Sun Yat-sen University

Prof

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prophylactic or Preemptive Entecavir in Patients With Gastric Cancer Who Are Inactive Hepatitis B Carriers	NCT02777801	Stomach Neoplas...	Entecavir	18 Years - 75 Years	Sun Yat-sen University
Prophylactic or Preemptive Entecavir in Patients With Gastric Cancer Who Are Inactive Hepatitis B Carriers	NCT02777801	Stomach Neoplas...	Entecavir	18 Years - 75 Years	Sun Yat-sen University
Prophylactic or Preemptive Entecavir in Patients With Gastric Cancer Who Are Inactive Hepatitis B Carriers	NCT02777801	Stomach Neoplas...	Entecavir	18 Years - 75 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for hepatitis b carrier