Actively Recruiting
Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers
Led by Sun Yat-sen University · Updated on 2025-05-11
136
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 and 75 years
- Histology-proven locally advanced unresectable or metastatic gastrointestinal cancers including colorectal, gastric, esophageal, hepatocellular carcinoma, pancreatic, and cholangiocarcinoma
- Planned to receive first-, second-, or third-line chemotherapy or PD-1/PD-L1 immunotherapy
- Eastern Cooperative Oncology Group performance status (ECOG) of 0 to 2
- Planned for at least 4 cycles of chemotherapy or immunotherapy
- Life expectancy of at least 6 months from recruitment date
- Chronic or past hepatitis B infection with inactive status (HBsAg-positive or HBcAb-positive)
- Normal liver function tests (ALT, AST, bilirubin)
- Negative hepatitis B virus DNA
- Adequate major organ function based on labs within 14 days before randomization
- Signed informed consent
- Good compliance during chemotherapy and follow-ups
You will not qualify if you...
- History of liver cirrhosis
- Prior hepatitis B virus reactivation
- Anti-HBV therapy within 6 months before enrollment
- Active co-infection with other hepatitis viruses
- HIV infection
- Autoimmune hepatitis
- History of or scheduled hepatic radiotherapy or radioisotope therapy
- Pregnancy or lactation
- History of psychiatric drug abuse or unmanaged mental disorder
- Immunodeficiency, congenital or acquired, or transplantation history
- Any serious concomitant disease that may risk safety or study completion as judged by investigators
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
X
Xu Rui-hua, M.D. Ph.D
CONTACT
W
Wang Feng, M.D. Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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