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Recruiting NCT05919238

Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma

Conditions: Locally Advanced Unresectable Pancreatic Adenocarcinoma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 30
Sponsor: Impact Biotech Ltd

Location: City of Hope Duarte California

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 as defined by the Response Evaluation Criteria in Solid Tumors according to RECIST 1.1 9. ECOG performance status ≤ 1 10. Life expectancy at least 6 months 11. No evidence of metastatic disease by CT scan chest, abdomen and pelvis performed within 28 days prior to treatment 12. Adequate organ system function including: a. Absolute neutrophil count (ANC) ≥1500/mm3 without the use of hemopoietic growth factors within the 7 days before VTP treatment b. Absolute white blood cell count ≥3.0\*109/L c. Hemoglobin at least 10g/dL d. Platelet count ≥75,000/mm3 e. International normalized ratio (INR) \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05919238). StuddyBuddy aggregates publicly available trial information.