A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjenci z niedawno zdiagnozowanym, nieoperacyjnym rakiem trzustki, który nie rozprzestrzenił się na inne części ciała.
- •Choroba nie jest zaawansowana (stan pacjenta pozwala na normalne, codzienne czynności, z niewielkimi ograniczeniami).
- •Pacjenci mogli wcześniej otrzymać pewne rodzaje chemioterapii, ale leczenie to nie zakończyło się sukcesem.
✗ Disqualifies
- •Pacjenci z ciężkim zapaleniem trzustki.
- •Pacjenci, którzy wcześniej otrzymali radioterapię z powodu raka trzustki.
- •Pacjenci, u których stwierdzono obecność przerzutów raka trzustki lub innego nowotworu.
- •Pacjenci z problemami kardiologicznymi.
- •Pacjenci z metalowymi implantami w ciele.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 6, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (2)
University of Michigan Health
Ann Arbor, United States
West Virginia University
Morgantown, United States
Trial contact
Allison Marquette
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/7/2026.
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