NCT02777801

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DRUG	Entecavir	anti-HBV

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-12-01
• Completion: 2018-06-01
• First posted: 2016-05-19
• Last updated: 2017-10-13

Locations

1 site across 1 country: China