Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers
Recruiting · NCT06966232 · Interventional (participants receive a specific treatment) · Lead sponsor: Sun Yat-sen University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Sun Yat-sen University Cancer Center - Guangzhou, Guangdong, China