Condition: Pancreatic Adenocarcinoma Non-resectable · Sponsor: Continuity Biosciences, LLC
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.
This description comes directly from the study's public registry record.
Allison Marquette · 619-341-2232 · allison@continuitybiosciences.com
Always discuss trial participation with your own doctor first.
| University of Michigan Health | Ann Arbor, Michigan, United States | Recruiting |
| West Virginia University | Morgantown, West Virginia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07481383