NCT05723107PHASE1Recruiting
EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)
NYU Langone Health
Start Date
3/31/2023
Completion Date
3/1/2028
Summary
This is a single arm study in the treatment of pancreatic ductal adenocarcinoma (PDAC). The investigators propose to test the tolerability of chemotherapy plus endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) using the RF Electrode in patients receiving palliative second or third line therapy for unresectable non-metastatic pancreatic cancer.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* Diagnosed and histologically confirmed PDAC by biopsy
* Axial CT scan or MRI consistent with PDAC with at least 1 cm in greatest diameter
* ECOG performance status 0-2
* Patients with locally advanced PDAC, who have not responded or progressed on first line chemotherapy, are deemed not resectable based on multidisciplinary review, and show no evidence of distant metastasis
* Lesions between 1 - 4cm in size
Exclusion Criteria:
* Patients that show evidence of distant metastasis
* Endoscopically non-accessible mass
* Pregnant patients
* Inability to provide informed consent
* Lesions \<1cm, or \>4cm in greatest diameter
Interventions
DRUG
Chemotherapy
DEVICE
Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA)
Conditions
Pancreatic Cancer
Locations
Tisch Hospital
New York, New York 10016
United States