Recruiting
Phase 1

EUS RFA

Sponsor:

NYU Langone Health

Code:

NCT05723107

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chemotherapy

Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA)

Study Details

Brief 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.

Conditions

Pancreatic Cancer

Study ID

NCT05723107

Start date

Mar 31, 2023

Status verified date

Nov, 2025

Completion date

Mar, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

Chemotherapy

Patients will receive continuation of second or initiate third-line chemotherapy regimen at the discretion and decision of treating oncologist.

Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA)

EUS-RFA will be delivered using the EUSRA RF Electrode, which is a sterile, single-use electrosurgical accessory for coagulation and ablation of soft tissue when used in conjunction with compatible radio frequency generator (VIVA Combo RF Generator).

The device will be used during a routine EUS, which is a minimally invasive procedure used to assess gastrointestinal diseases. Each EUS-RFA procedure will last approximately 60 minutes.

Primary outcome measure

  • Percentage of Participants who Complete Therapy without Grade III-IV Adverse Events (AEs) as Assessed by CTCAE v. 5.0 [ Time Frame: Up to Week 15 ]

Central Contacts and Locations

Central contacts

Tamas A. Gonda, MD

212-263-3095Tamas.Gonda@nyulangone.org

Emil Agarunov

212-263-3095Emil.agarunov@nyulangone.org

Locations

Tisch Hospital

Recruiting

New York, New York, United States, 10016

Contacts

Tamas A. Gonda, MD

212-263-3095Tamas.Gonda@nyulangone.org

More Information

Sponsor

NYU Langone Health

Last update posted

Nov 28, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-11-28.