EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)

NYU Langone Health

Status and phase: Enrolling; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: Chemotherapy; Device: Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05723107

22-00249

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Chemotherapy plus EUS-RFA

Experimental group

Description:

Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) and chemotherapy will be administered as part of standard of care treatment for PDAC in patients receiving palliative second- or third-line therapy for unresectable non-metastatic pancreatic cancer. Study participants will undergo 3 identical EUS-RFA procedures, administered during Study Window 2 (Weeks 1-3), Window 3 (Weeks 5-7), and Window 4 (Weeks 9-11). During each EUS-RFA procedure, a tumor biopsy will also be taken for single cell RNA sequencing. Chemotherapy will be administered during Study Window 2 (Weeks 1-3), Window 3 (Weeks 5-7), Window 4 (Weeks 9-11), and Window 5 (Weeks 13-15).

Treatment:

Device: Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA)

Drug: Chemotherapy