Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT06966232
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 receive first-, second-, or third-line anti-tumor therapy (chemotherapy or PD-1/PD-L1 monoclonal antibody immunotherapy)
4. Patients with Eastern Cooperative Oncology Group performance status (ECOG) of 0-2
5. Patients planned for at least 4 cycles of chemotherapy or immunotherapy
6. Patients with at least 6 months' life expectancy from date of recruitment
7. Patients with chronic or past HBV infection (HBsAg-positive or HBcAb-positive), and hepatitis B is inactive
8. Patients with normal liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase alkaline (AST), and bilirubin
9. Patients with negative HBV-DNA
10. Adequate major organ function (laboratory tests 14 days before randomization meeting requirements for anti-tumor therapy)
11. Patients who sign the informed consent
12. Patients with good compliance during chemotherapy and follow-ups.
Exclusion Criteria:
1. History of liver cirrhosis
2. Prior HBV reactivation
3. Received anti-HBV therapy for chronic hepatitis B within 6 months before enrollment
4. Active co-infection with other hepatitis viruses
5. HIV infection
6. Autoimmune hepatitis
7. History of hepatic radiotherapy
8. Scheduled hepatic radiotherapy or radioisotope therapy
9. Pregnant or lactating women
10. Patients with a history of psychiatric drugs abuse and can't quit or with a mental disorder
11. Patients with immunodeficiency, other congenital or acquired immunodeficiency, or transplantation history
12. According to the investigators' judgment, patients with concomitant disease that seriously harms patients' safety or the completion of study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06966232
Study Brief:
Protocol Section:
NCT06966232