Clinical trial · Interventional
Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study
Phase II Study of EUS-Guided Verteporfin PDT in Solid Pancreatic Tumors (VERTPAC-02)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Pancreatic Carcinoma | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
| Locally Advanced Pancreatic Carcinoma | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Pancreatic Carcinoma | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
| Pancreatic Neoplasm | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Stage III Pancreatic Cancer AJCC v8 | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Pancreatic Cancer AJCC v8 | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Pancreatic Cancer AJCC v8 | Malignant Pancreatic Neoplasm | CURATED_BROADER |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Ultrasound | Procedure | — | UNRESOLVED |
| Fluorescence Imaging | Procedure | — | UNRESOLVED |
| Photodynamic Therapy | Drug | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Verteporfin | Drug | Verteporfin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (verteporfin, EUS-guided PDT)
- description
- Patients receive verteporfin IV and undergo fluorescence imaging and after 60 minutes undergo EUS-guided PDT.
- interventionNames
- Procedure: Endoscopic Ultrasound
- Procedure: Fluorescence Imaging
- Drug: Photodynamic Therapy
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Drug: Verteporfin
Primary outcomes (1)
- measure
- Tumor Response
- timeFrame
- Baseline (up to 28 days before PDF); 2 days post PDT; Up to 12 months post PDT
- description
- Assessed by the number of participants who did or did not respond, evaluated by tumor necrosis as a function of delivered energy, based on pre-photodynamic therapy (PDT) contrast computed tomography (CT) scans. Tumor volume response was graded per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CT scans were obtained on day 2 following PDT. Most patients (87.5%) had a repeat CT of the abdomen and pelvis for reasons unrelated to the study; these CTs were also reviewed for tumor response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * Porphyria * 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
References
Publications (2)
- RESULTHanada Y, Pereira SP, Pogue B, Maytin EV, Hasan T, Linn B, Mangels-Dick T, Wang KK. EUS-guided verteporfin photodynamic therapy for pancreatic cancer. Gastrointest Endosc. 2021 Jul;94(1):179-186. doi: 10.1016/j.gie.2021.02.027. Epub 2021 Feb 26. PMID 33647286
- DERIVEDVincent P, Maeder ME, Hunt B, Linn B, Mangels-Dick T, Hasan T, Wang KK, Pogue BW. CT radiomic features of photodynamic priming in clinical pancreatic adenocarcinoma treatment. Phys Med Biol. 2021 Aug 23;66(17):175006. doi: 10.1088/1361-6560/ac1458. PMID 34261044