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:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT03856658
Eligibility Criteria:
Inclusion Criteria:
* Biopsy-proved pancreatic adenocarcinoma with synchronous liver metastases
* Elevated Cancer Antigen 19-9 (CA19-9) at diagnosis (\>37 U/mL)
* Ages 18-75 years
* Karnofsky performance status ≥70
* Ability to undergo general anesthesia and HAI pump placement procedure
* CT or MRI scan imaging of the abdomen demonstrating accessibility of the gastroduodenal artery within 2 months of enrollment
* Received a minimum of 2 months of systemic chemotherapy with stable tumor markers and imaging.
Exclusion Criteria:
* Primary tumor resected
* Model for End Stage Liver Disease (MELD) score \>20, using the variables of: Bilirubin, serum Sodium, International Normalized Ratio (INR), serum Creatinine, and Dialysis twice in the past week.
* Greater than 60% liver parenchymal involvement by tumor
* Evidence of peritoneal metastases
* Current alcohol abuse
* Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03856658
Study Brief:
Protocol Section:
NCT03856658