RecruitingPhase 3NCT06966232

Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers

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

Sponsor

Sun Yat-sen University

Enrollment

136 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Gastrointestinal Cancers

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria12

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 Criteria12

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.