Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study

  • End date
    Jul 8, 2024
  • participants needed
  • sponsor
    Mayo Clinic
Updated on 8 September 2023
measurable disease
endoscopic ultrasound
metastatic pancreatic cancer
pancreatic neoplasm


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.



I. To show that endoscopic ultrasound (EUS)-guided photodynamic therapy (PDT) to the pancreas is effective at direct ablation of advanced or locally advanced and small volume metastatic pancreatic tumors in a multicenter setting.


I. To evaluate the predictability of tumor necrosis as a function of delivered energy, based on pre-PDT contrast computed tomography (CT) scans.


I. Evaluate the safety of chemotherapy given two days after PDT.


I. Demonstrate that cancer biomarkers in pre- versus (vs.) post-PDT are surrogate markers of response.


Patients receive verteporfin intravenously (IV) and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.

After completion of study treatment, patients are followed up at 14 days, and at 3, 6, and 12 months.

Condition Advanced Pancreatic Carcinoma, Locally Advanced Pancreatic Carcinoma, Metastatic Pancreatic Carcinoma, Pancreatic Neoplasm, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Unresectable Pancreatic Carcinoma
Treatment verteporfin, questionnaire administration, quality-of-life assessment, photodynamic therapy, fluorescence imaging, Endoscopic Ultrasound, Verteporfin PDT
Clinical Study IdentifierNCT03033225
SponsorMayo Clinic
Last Modified on8 September 2023


Yes No Not Sure

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 < 2.5 upper limit of normal [ULN]), with no evidence of active uncontrolled infection (patients on antibiotics are eligible)
Women of child-bearing potential with a negative pregnancy test (qualitative serum human chorionic gonadotropin [HCG]) prior to study entry AND must be using an adequate contraception method, which must be continued for 1 week after PDT

Exclusion Criteria

For locally advanced patients, evidence of metastases other than lung or liver. For lung metastases, greater than three lesions and any lesions greater than 5 cm are excluded. For advanced patients, any metastasis is acceptable for enrollment
Pregnant or breast-feeding
Locally advanced disease involving > 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
Clear my responses

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