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

Colorectal Neoplasms Clinical Trial

Official title:

An Open, Randomized Controlled Clinical Trial to Compare the Prophylactic Use or Preemptive Use of an Anti-viral Drug Entecavir in Patients With Colorectal Cancer Who Are Inactive Hepatitis B Carriers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02777814
• Other study ID #: CRC-HBV
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2015
• Est. completion date: November 2019

Study information

• Verified date: January 2019
• Source: Sun Yat-sen University
• Contact: Rui-hua Xu, M.D. Ph.D.
• Phone: +86-20-87343295
• Email: xurh[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There has been no report on whether the patients with colorectal 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 colorectal cancer who are also inactive hepatitis B carriers during chemotherapy and the subsequent follow-ups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients with age between 18 and 75

2. Patient with histology-proven colorectal 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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Hepatitis
• Hepatitis B

Intervention

Drug:
• Entecavir
anti hepatitis B virus

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

Di Bisceglie AM, Lok AS, Martin P, Terrault N, Perrillo RP, Hoofnagle JH. Recent US Food and Drug Administration warnings on hepatitis B reactivation with immune-suppressing and anticancer drugs: just the tip of the iceberg? Hepatology. 2015 Feb;61(2):703-11. doi: 10.1002/hep.27609. Review. — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Interruption of chemotherapy due to hepatitis	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