NCT06966232

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P25-P50 for phase_3

Timeline
13mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
May 2025May 2027

First Submitted

Initial submission to the registry

May 2, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

May 15, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2027

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2027

Last Updated

May 11, 2025

Status Verified

April 1, 2025

Enrollment Period

2 years

First QC Date

May 2, 2025

Last Update Submit

May 2, 2025

Conditions

Gastrointestinal Cancers

Keywords

Gastrointestinal CancersEntecavirHepatitis B CarrierChemotherapyImmunotherapy

Outcome Measures

Primary Outcomes (1)

  • The incidence of hepatitis B virus reactivation

    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 Outcomes (6)

  • Hepatitis

    through study completion, an average of 1 year

  • Hepatitis B virus associated hepatitis

    through study completion, an average of 1 year

  • Interruption of chemotherapy/immunotherapy due to hepatitis

    through study completion, an average of 1 year

  • Severe HBV associated hepatitis

    through study completion, an average of 1 year

  • HBV associated acute liver failure

    through study completion, an average of 1 year

  • +1 more secondary outcomes

Study Arms (2)

Prophylactic Entecavir

EXPERIMENTAL

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

Preemptive Entecavir

ACTIVE COMPARATOR

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

Interventions

EntecavirDRUG

anti hepatitis B virus

Also known as: Entecavir Dispersible Tablets
Preemptive EntecavirProphylactic Entecavir

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • History of liver cirrhosis
  • Prior HBV reactivation
  • Received anti-HBV therapy for chronic hepatitis B within 6 months before enrollment
  • Active co-infection with other hepatitis viruses
  • HIV infection
  • Autoimmune hepatitis
  • History of hepatic radiotherapy
  • Scheduled hepatic radiotherapy or radioisotope therapy
  • Pregnant or lactating women
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (2)

  • 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: 25447852BACKGROUND

  • 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: 25514302BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

entecavir

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Xu Rui-hua, M.D. Ph.D

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Rui-hua, M.D. Ph.D

CONTACT

+86-20-87343008xurh@sysucc.org.cn

Wang Feng, M.D. Ph.D

CONTACT

+86-18620880867fengwang@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The president of Sun Yat-sen University Cancer Center

Study Record Dates

First Submitted

May 2, 2025

First Posted

May 11, 2025

Study Start

May 15, 2025

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

May 20, 2027

Last Updated

May 11, 2025

Record last verified: 2025-04

Locations

CN(1)