Using Entecavir to Prevent Hepatitis B Reactivation in Gastrointestinal Cancer Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 clinical trial investigates the effects of prophylactic versus preemptive use of the antiviral drug entecavir in patients with gastrointestinal cancer who are inactive hepatitis B carriers. Participants are randomized into two groups: one receiving entecavir from the start of their chemotherapy or immunotherapy, and the other receiving it only when hepatitis B virus DNA becomes detectable. The study aims to assess the impact of these treatment strategies on patient outcomes during and after anti-tumor therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Xu Rui-hua, M.D. Ph.D — Sun Yat-Sen University Cancer Center
• Study coordinator: Xu Rui-hua, M.D. Ph.D
• Email: xurh@sysucc.org.cn
• Phone: +86-20-87343008

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.