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NCT Number: NCT06966232

Prophylactic or Preemptive 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.

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Key information

Conditions

Gastrointestinal Cancers Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Feng Wang

CONTACT

[email protected]

+86-20-87342479

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Entecavir

Drug

anti hepatitis B virus

Other names: Entecavir Dispersible Tablets

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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.

  3. 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 .

  4. 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.

  5. 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.

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Wang Feng, M.D. Ph.D

CONTACT

[email protected]

+86-18620880867

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

CONTACT

[email protected]

+86-20-87343008

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 11, 2025
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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