Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1Patient is 18 years of age and older 2. Patient is capable of giving written informed consent 3. Patients with a diagnosis of Stage III pancreatic ductal adenocarcinoma, cytologically or histologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria 4. 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) 5. Patients with LA PDAC located in the head/uncinate process of the pancreas 6. Patient with target artery solid tumor contact ˃180° for a total contact length up to 3cm, and with entire target artery internal diameter 5-10 mm. 7. All patients will be approved by a multi-disciplinary team (including medical oncologist, surgeon, interventional radiologist) as appropriate for endovascular VTP treatment. 8. Measurable disease