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

May 2, 2025 updated by: Rui-hua Xu, MD, PhD, Sun Yat-sen University

An Open, Multicentre, Phase 3, Randomized Controlled Clinical Trial to Compare the Prophylactic Use or Preemptive Use of an Anti-viral Drug Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers

There has been no report on whether the patients with gastrointestinal cancer who are also inactive hepatitis B carriers should receive prophylactic use or preemptive use of an anti-viral drug entecavir during anti-tumor therapy. This open, multicentre, phase 3, 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 gastrointestinal cancer who are also inactive hepatitis B carriers during chemotherapy or immunotherapy and the subsequent follow-ups, including two cohorts of chemotherapy and immunotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with gastrointestinal 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 or immunotherapy till 6 months after the end of chemotherapy or immunotherapy. 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 become positive till 6 months after the end of chemotherapy or immunotherapy.

Study Type

Interventional

Enrollment (Estimated)

136

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with age between 18 and 75
  2. Patient with histology-proven locally advanced unresectable or metastatic gastrointestinal cancers (colorectal cancer, gastric cancer, esophageal cancer, hepatocellular carcinoma, pancreatic cancer, and cholangiocarcinoma)
  3. Planned to receive first-, second-, or third-line anti-tumor therapy (chemotherapy or PD-1/PD-L1 monoclonal antibody immunotherapy)
  4. Patients with Eastern Cooperative Oncology Group performance status (ECOG) of 0-2
  5. Patients planned for at least 4 cycles of chemotherapy or immunotherapy
  6. Patients with at least 6 months' life expectancy from date of recruitment
  7. Patients with chronic or past HBV infection (HBsAg-positive or HBcAb-positive), and hepatitis B is inactive
  8. Patients with normal liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase alkaline (AST), and bilirubin
  9. Patients with negative HBV-DNA
  10. Adequate major organ function (laboratory tests 14 days before randomization meeting requirements for anti-tumor therapy)
  11. Patients who sign the informed consent
  12. Patients with good compliance during chemotherapy and follow-ups.

Exclusion Criteria:

  1. History of liver cirrhosis
  2. Prior HBV reactivation
  3. Received anti-HBV therapy for chronic hepatitis B within 6 months before enrollment
  4. Active co-infection with other hepatitis viruses
  5. HIV infection
  6. Autoimmune hepatitis
  7. History of hepatic radiotherapy
  8. Scheduled hepatic radiotherapy or radioisotope therapy
  9. Pregnant or lactating women
  10. Patients with a history of psychiatric drugs abuse and can't quit or with a mental disorder
  11. Patients with immunodeficiency, other congenital or acquired immunodeficiency, or transplantation history
  12. According to the investigators' judgment, patients with concomitant disease that seriously harms patients' safety or the completion of study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prophylactic Entecavir
Entecavir is prophylactically used from the time of chemotherapy or immunotherapy initiation at the dose of 0.5 mg p.o daily till 6 months after the end of chemotherapy or immunotherapy .
Drug: Entecavir
anti hepatitis B virus
Other Names:
  • Entecavir Dispersible Tablets
Active Comparator: Preemptive Entecavir
Entecavir is preemptively used from the time that hepatitis B virus DNA copies become positive at the dose of 0.5 mg p.o daily till 6 months after the end of chemotherapy or immunotherapy.
Drug: Entecavir
anti hepatitis B virus
Other Names:
  • Entecavir Dispersible Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of hepatitis B virus reactivation
Time Frame: through study completion, an average of 1 year
HBV reactivation is defined as (1) an increase in HBV-DNA levels by ≥2 log10 (100-fold) compared to baseline or conversion from negative serum HBV-DNA to positive HBV-DNA; (2) if baseline HBV-DNA was undetectable, achieving HBV-DNA levels ≥3 log10 (1,000 IU/mL); or (3) if baseline levels were unknown or unavailable, reaching HBV-DNA levels ≥4 log10 (10,000 IU/mL).
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatitis
Time Frame: through study completion, an average of 1 year
Hepatitis is defined as a 3-fold or greater increase in the serum ALT level that exceeded the reference range 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
Hepatitis B virus associated hepatitis
Time Frame: through study completion, an average of 1 year
Hepatitis B virus associated hepatitis is defined as hepatitis B virus (HBV) reactivation occurring prior to or concurrent with hepatitis during or following chemotherapy/immunotherapy , in the absence of clinical or laboratory evidence of acute infection by other hepatitis viruses or systemic diseases.
through study completion, an average of 1 year
Interruption of chemotherapy/immunotherapy due to hepatitis
Time Frame: through study completion, an average of 1 year
Chemotherapy/immunotherapy disruption due to hepatitis is defined as either premature termination or a delay of at least 7 days between therapy cycles due to hepatitis .
through study completion, an average of 1 year
Severe HBV associated hepatitis
Time Frame: through study completion, an average of 1 year
Severe HBV associated hepatitis is defined as grade 3 or higher HBV associated hepatitis according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
through study completion, an average of 1 year
HBV associated acute liver failure
Time Frame: through study completion, an average of 1 year
HBV associated acute liver failure, also termed HBV associated fulminant hepatic failure , is defined as acute hepatic decompensation linked to HBV reactivation or acute exacerbation of HBV infection. It manifests within days to weeks, leading to severe complications such as coagulopathy, hepatic encephalopathy, and multiorgan failure, with a high 28-day mortality rate . Delayed initiation of nucleotide analogues may contribute to rapid disease progression and poor prognosis.
through study completion, an average of 1 year
HBV related death
Time Frame: through study completion, an average of 1 year
HBV related death is defined as mortality directly attributable to HBV reactivation
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Xu Rui-hua, M.D. Ph.D, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2025

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

May 20, 2027

Study Registration Dates

First Submitted

May 2, 2025

First Submitted That Met QC Criteria

May 2, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIC-HBV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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