Using Entecavir to Prevent Hepatitis B Reactivation in Gastrointestinal Cancer Patients
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
This study is testing whether giving the antiviral drug entecavir early or only when needed can help prevent hepatitis B from getting worse in patients with gastrointestinal cancer who carry the virus.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06966232 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced or metastatic gastrointestinal cancers who are inactive hepatitis B carriers.
Not a fit: Patients with active hepatitis B infection or those not receiving chemotherapy or immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of hepatitis B reactivation in cancer patients undergoing treatment.
How similar studies have performed: While the specific approach of using entecavir in this context is novel, similar studies have shown the importance of managing hepatitis B in cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.