Phase 2
N=13
Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study
Advanced Pancreatic Carcinoma · Locally Advanced Pancreatic Carcinoma · Metastatic Pancreatic Carcinoma · Pancreatic Neoplasm · Stage II Pancreatic Cancer AJCC v8
Bottom Line
View on ClinicalTrials.gov: NCT03033225 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Tumor Response — 5; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Endoscopic Ultrasound (Procedure); Fluorescence Imaging (Procedure); Photodynamic Therapy (Drug); Quality-of-Life Assessment (Other); Questionnaire Administration (Other); Verteporfin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Response |
5; 3 | — |
Summary
This phase II trial studies how well ultrasound-guided verteporfin photodynamic therapy works for the treatment of patients with solid pancreatic tumors that cannot be removed by surgery (unresectable) or pancreatic cancer that has spread to other places in the body (advanced). Photodynamic therapy is a type of laser device that is guided by ultrasound imaging and used in combination with the drug verteporfin that may be less invasive and as effective as current treatment methods for patients with pancreatic cancer.
Eligibility Criteria
Inclusion Criteria
- Histological/cytological diagnosis (Dx) of advanced or locally advanced or small volume metastatic pancreatic cancer (PanCa) or other solid pancreatic tumor that is not amenable to curative surgical resection, or the patient is unfit, or declines surgery
- Age > 18 years
- Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Estimated life expectancy of at least 12 weeks
- Capable of giving written informed consent
- Adequate biliary drainage (serum bilirubin 50% circumference of the duodenum or a major artery within the treatment area
- ECOG performance status 3 or 4
- Previous treatment with curative intent for current disease within the past two weeks (i.e. prior resection, radical radiotherapy or chemotherapy)
- Any psychiatric disorder making reliable informed consent impossible
- A history of documented hemorrhagic diathesis or coagulopathy on therapeutic anticoagulation
- History of prior or concomitant other malignancy that will interfere with the response evaluation
- Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial
- Contrast allergy not amenable to treatment with steroids and antihistamines
Data sourced from ClinicalTrials.gov (NCT03033225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.