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

NCT02777801 | Unknown Phase 2 DMC

• 1 other identifier: GC-HBV
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Neoplasms

Keywords

gastric cancer; hepatitis B carrier; entecavir

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• The incidence of hepatitis B virus reactivation

  through study completion, an average of 1 year

• Interruption of chemotherapy due to hepatitis

  through study completion, an average of 1 year

Study Arms (2)

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.

Drug: Entecavir

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.

Drug: Entecavir

Interventions

Entecavir DRUG

anti-HBV

Also known as: Entecavir Dispersible Tablets

Preemptive Entecavir; Prophylactic Entecavir

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with age between 18 and 75
• Patient with histology-proven gastric adenocarcinoma.
• Patients with Eastern Cooperative Oncology Group performance status (ECOG) of 0-1
• Patients planned for at least 4 cycles of cytotoxic chemotherapy (either as part of curative therapy or as palliative therapy)
• Patients with at least 6 months' life expectancy from date of recruitment
• Patients with positive Hepatitis B Surface-antigen (HBsAg)
• Patients with normal liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase alkaline (AST), phosphatase (ALP), gamma glutamyl-transpeptidase (GGT), and bilirubin
• Patients with negative HBV-DNA
• 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
• Patients with no evidence of autoimmune hepatitis, hepatitis C or D virus infection, HIV infection or radiological evidence of liver metastasis
• adequate bone marrow, hepatic, and renal function within 14 days before recruitment
• patients who sign the informed consent
• Patients with good compliance during chemotherapy and follow-ups

You may not qualify if:

• Patients planned for radiation or radionuclide therapy
• Pregnant female patients
• Patients with a history of psychiatric drugs abuse and can't quit or with a mental disorder
• Patients with immunodeficiency, other congenital or acquired immunodeficiency, or transplantation history
• According to the investigators' judgment, patients with concomitant disease that seriously harms patients' safety or the completion of study.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 25514302 RESULT

• 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.

  PMID: 25447852 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

entecavir

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Rui-hua Xu, PHD,MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui-hua Xu, PHD,MD

CONTACT

+86 13922206676; xurh@sysucc.org.cn

Feng Wang, PHD,MD

CONTACT

+86 18620880867; wangfeng@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: May 19, 2016
• Study Start: June 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: October 13, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)