Entecavir Timing in Gastrointestinal Cancer Patients With Inactive Hepatitis B
Compares early versus as-needed entecavir in adults with gastrointestinal cancer and inactive hepatitis B.
Plain-language title generated from the registry record
Registry title: Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06966232, who can take part
Where in China
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sun Yat-sen University
- Trial code
- NCT06966232
- Record updated
- 11 May 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Prior HBV reactivation; Received anti-HBV therapy for chronic hepatitis B within 6 months before enrollment; Scheduled hepatic radiotherapy or radioisotope therapy; 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; History of liver cirrhosis; Active co-infection with other hepatitis viruses; HIV infection; Autoimmune hepatitis; History of hepatic radiotherapy; Patients with a history of psychiatric drugs abuse and can't quit or with a mental disorder; Pregnant or lactating women.