This study is being done to find out if delivering gemcitabine using the ACT-IOP-003 device directly to the area where the tumor is in the pancreas is safe and tolerable. The main questions the study aims to answer are: * Is ACT-IOP-003 safe and tolerable when given to patients with nonmetastatic, locally advanced, nonresectable pancreatic cancer. * How much study drug (gemcitabine) is found in the blood before and after treatment. * If the tumor responds to treatment. * If the gemcitabine side effects are less than seen when delivered intravenously (IV). Study participants will: * Have the study device surgically placed on the pancreas at the beginning of the study. * Complete 8 weeks of treatment with a 4 week screening period and 12 weeks of follow-up for a total of 24 weeks of participation in the study. * Give blood, urine, and stool samples to monitor safety and determine how much of the study drug (gemcitabine) is in the blood. * Have imaging (CT) done at least three times during the study.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Timeframe: Screening through Week 20
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Timeframe: Screening through Week 20
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Timeframe: Screening through Week 20
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Timeframe: Screening through Week 20
Safety, Tolerability, and Maximum Tolerated Delivered Dose as Assessed by Adverse Event Reporting
Timeframe: Screening through Week 20