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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Colorectal Neoplasms

Treatments: Drug: Entecavir

Study type: Interventional

Funder types: Other

Identifiers

NCT02777814

CRC-HBV

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Prophylactic Entecavir

Experimental group

Description:

Entecavir is prophylactically used from the time of chemotherapy initiation at the dose of 0.5 mg p.o daily

Treatment:

Drug: Entecavir

Preemptive Entecavir

Active Comparator group

Description:

Entecavir is preemptively used from the time that hepatitis B virus DNA copies are more than 100 IU/ml at the dose of 0.5 mg p.o daily

Treatment:

Drug: Entecavir