Clinical trial NCT02777814: Prophylactic or Preemptive Entecavir in Patients With Colorectal Cancer Who Are Inactive Hepatitis B Carriers
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Neoplasms
Keywords: colorectal cancer
Entecavir
Hepatitis B Carrier
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of hepatitis B virus associated hepatitis
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Incidence of hepatitis B virus reactivation
timeFrame: through study completion, an average of 1 year
measure: Interruption of chemotherapy due to hepatitis
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Rui-hua Xu, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 chemotherapy: a randomized clinical trial. JAMA. 2014 Dec 17;312(23):2521-30. doi: 10.1001/jama.2014.15704.
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: 10.1053/j.gastro.2014.10.038. Epub 2014 Oct 31. No abstract available.