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Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma

NCT05919238 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-12

No results posted yet for this study

Summary

This is a prospective, multicenter, non-randomized, open label light dose escalation phase I trial to evaluate the safety and preliminary efficacy of Padeliporfin vascular targeted photodynamic therapy (VTP) applied via endovascular fiber placement within a dilatation catheter, through the target artery(superior mesenteric artery (SMA), celiac artery (CA) or common hepatic artery (CHA)). The investigators will evaluate safety and preliminary efficacy of Padeliporfin VTP administered endovascularly using light dose escalation.

Conditions

  • Locally Advanced Unresectable Pancreatic Adenocarcinoma

Interventions

COMBINATION_PRODUCT

Padeliporfin Vascular Targeted Photodynamic (VTP) therapy

The laser light fiber with inflatable balloon to dam SMA blood flow during light illumination will be placed by an Interventional Radiologist in the SMA via a transfemoral artery approach. The balloon will be inflated to impede blood flow for total of 10 minutes during light illumination

Sponsors & Collaborators

  • Impact Biotech Ltd

    lead INDUSTRY

Principal Investigators

  • Nadine Abi-Jaoudeh, MD · University of California, Irvine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2026-05-30
Completion
2026-10-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05919238 on ClinicalTrials.gov