Padeliporfin VTP for Unresectable Pancreatic Cancer
This study is testing a new treatment called Padeliporfin Vascular Targeted Photodynamic (VTP) therapy for people with locally advanced pancreatic cancer that cannot be removed by surgery. This treatment involves placing a special fiber into an artery (like the superior mesenteric artery) to deliver light, after you receive Padeliporfin intravenously. The light activates the Padeliporfin to treat the tumor. Researchers want to find out how safe this treatment is and the best light dose to use. About 30 people will participate. You may be able to join if you are 18 or older and have been diagnosed with Stage III pancreatic ductal adenocarcinoma.
- Study design
- This is a Phase 1 study, meaning it's an early-stage trial. It is not randomized and is open-label, meaning both you and the study team will know what treatment you are receiving. It plans to enroll about 30 participants.
- What's involved
- You will receive Padeliporfin intravenously, followed by a procedure where a fiber is placed in an artery for 10 minutes of light illumination. The study will evaluate your safety at Day 30.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be checked at Day 30 after the treatment.
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Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Nadine Abi-Jaoudeh, MD · PRINCIPAL_INVESTIGATOR · University of California, Irvine
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Safety of endovascularly applied Padeliporfin VTP ablationDay 30
Safety of endovascularly applied Padeliporfin VTP ablation will be assessed using the CTCAE version 5.0. All adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) for being included in analyses.
- Determination of the Maximum Tolerated Light Dose (MTD) and/or Recommended Phase 2 light dose (RP2D) in Part ADay 30
MTD is defined as the dose level associated with \<33% of DLT-evaluable patients experiencing a DLT. If the MTD is reached, the RP2D will be defined as MTD. If the MTD is not reached, the RP2D will be selected based on integrated evaluation of safety and clinical benefit for all dose levels tested.