Phase I Pilot Study of Endoscopic Ultrasound Guided RFA in Advanced Pancreatic Cancer

Trial ID: NCT05723107

Interventional - Phase 1 - Recruiting

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.

Conditions

• Pancreatic Cancer

Interventions

• Chemotherapy
• Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA)

Eligibility

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

Sponsor

NYU Langone Health, Taewoong Medical

Source: ClinicalTrials.gov

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