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New treatment option for Gastrointestinal Cancers
Official title Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers
ClinicalTrials.gov ID: NCT06966232
What this study is testing
What is Entecavir?
Entecavir is an investigational medicine, being studied as a potential treatment for gastrointestinal cancers.
Also referred to as Entecavir Dispersible Tablets.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients with age between 18 and 75
- Patient with histology-proven locally advanced unresectable or metastatic gastrointestinal cancers (colorectal cancer, gastric cancer, esophageal...
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.