A Phase I Trial to Evaluate Safety and Preliminary Efficacy of Endovascularly Applied Padeliporfin Vascular Targeted Photodynamic Therapy for Patients with Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma
Details
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 superior mesenteric artery (SMA) in patients with stage III, locally advanced (LA) unresectable pancreatic ductal adenocarcinoma (PDAC). The investigators will evaluate safety and preliminary efficacy of Padeliporfin VTP administered endovascularly using light dose escalation.
Eligibility
You can join if...
Inclusion Criteria
Patient is 18 years of age and older
Patients with a diagnosis of Stage III pancreatic ductal adenocarcinoma, cytologically or histologically confirmed
Patients have an unresectable tumor, evaluated as Stage III according to National Comprehensive Cancer Network (NCCN) guidelines resectability criteria, based on radiographic imaging or exploratory surgery as a locally advanced (LA) pancreatic ductal adenocarcinoma (PDAC)
Exclusion Criteria
Patients with metastatic (stage IV) disease
Patients with previous radiotherapy treatment for pancreatic cancer