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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Tisch Hospital
RECRUITING
New York
Contact Information
Primary
Tamas A. Gonda, MD
Tamas.Gonda@nyulangone.org
212-263-3095
Backup
Emil Agarunov
Emil.agarunov@nyulangone.org
212-263-3095
Time Frame
Start Date: 2023-03-31
Estimated Completion Date: 2028-03
Participants
Target number of participants: 15
Treatments
Experimental: Chemotherapy plus EUS-RFA
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).
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health
Collaborators: Taewoong Medical

This content was sourced from clinicaltrials.gov