Phase 3 Hepatitis B Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 18 and 75 years old
• You have been diagnosed with an advanced or spreading cancer of the digestive system (such as colorectal, stomach, esophageal, liver, pancreatic, or bile duct cancer) that cannot be surgically removed, confirmed by a tissue biopsy
• You are planned to receive your first, second, or third round of cancer treatment, either chemotherapy or a type of immunotherapy (checkpoint inhibitor drugs)
• You are well enough to carry out basic daily activities (your doctor has rated your general health and ability to function as good to moderate)
• You are expected to receive at least 4 rounds of chemotherapy or immunotherapy
• Your doctors expect you to live for at least 6 months from the time you join the trial
• You have a past or ongoing hepatitis B infection that is currently inactive (certain blood markers are present but the virus is not actively causing harm)
• Your liver function blood tests (including ALT, AST, and bilirubin) are within normal range
• A blood test shows no detectable hepatitis B virus activity (negative HBV-DNA)
• Your major organs (such as kidneys, heart, and blood cells) are working well enough for cancer treatment, confirmed by blood tests within 14 days before joining
• You are willing and able to sign a consent form agreeing to take part
• You are able to attend all required appointments and follow the study plan throughout treatment

Who may not be able to join:

• You have a history of liver cirrhosis (severe liver scarring)
• You have previously had a hepatitis B "reactivation" (the virus became active again after a period of being dormant)
• You have received treatment specifically for chronic hepatitis B within the past 6 months
• You currently have an active infection with another hepatitis virus (such as hepatitis C or D)
• You have HIV infection
• You have autoimmune hepatitis (a condition where the immune system attacks the liver)
• You have previously had radiation therapy directed at your liver
• You are scheduled to have radiation therapy or radioactive treatment to the liver as part of your care
• You are pregnant or currently breastfeeding
• You have a history of psychiatric drug misuse that you are unable to stop, or you have a diagnosed mental health disorder
• You have a weakened immune system due to a medical condition, a condition you were born with, or because you have had an organ or tissue transplant
• You have another serious illness or condition that your doctor believes could put you at risk or prevent you from completing the study (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.