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

Recruiting Phase 3 Interventional Study
Gastrointestinal Cancers
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
136 (estimated)
Sponsor
Sun Yat-sen University · Other
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About This Trial
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…
Trial Locations
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Eligibility 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 …
Contacts

Xu Rui-hua, M.D. Ph.D

+86-20-87343008

xurh@sysucc.org.cn

CONTACT

Wang Feng, M.D. Ph.D

+86-18620880867

fengwang@sysucc.org.cn

CONTACT