OncoMatch/Clinical Trials/NCT07481383
A First-in-Human Study to Evaluate Implantable Iontophoresis Chemotherapy Delivery Device With Gemcitabine Once Weekly or Twice Weekly in Participants With Pancreatic Cancer
Is NCT07481383 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003) for pancreatic adenocarcinoma non-resectable.
Treatment: ACT Implantable Iontophoresis Chemotherapy Delivery Device with Gemcitabine (ACT-IOP-003) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Disease stage
Excluded: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy (FOLFIRINOX) — standard of care/neoadjuvant
Previously received prior standard of care/neoadjuvant chemotherapy of FOLFIRINOX
Must have received: platinum-based chemotherapy (GEM Abraxane) — standard of care/neoadjuvant
Previously received prior standard of care/neoadjuvant chemotherapy of GEM Abraxane
Cannot have received: radiation therapy
Prior radiation treatment as part of standard of care/neoadjuvant treatment for pancreatic cancer.
Lab requirements
Cardiac function
Any medical history of past or present cardiovascular disease related to heart function [excluded]
Any medical history of past or present cardiovascular disease related to heart function.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- West Virginia University · Morgantown, West Virginia
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