EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Chemotherapy; Device: Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA)

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Tamas A. Gonda, MD; Phone Number: 212-263-3095; Email: Tamas.Gonda@nyulangone.org
• Study Contact Backup: Name: Emil Agarunov; Phone Number: 212-263-3095; Email: Emil.agarunov@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • Tisch Hospital
      • Contact: Tamas A. Gonda, MD; Phone Number: 212-263-3095; Email: Tamas.Gonda@nyulangone.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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).

Drug: Chemotherapy; Patients will receive continuation of second or initiate third-line chemotherapy regimen at the discretion and decision of treating oncologist.; Device: 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.; Other Names: EUSRA RF Electrode

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants who Complete Therapy without Grade III-IV Adverse Events (AEs) as Assessed by CTCAE v. 5.0	Per Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0, Grade III AEs are defined as severe or medically significant but not immediately life-threatening; or hospitalization or prolongation of hospitalization indicated; or disabling; or limiting self care activities of daily living. Grade IV AEs are defined as life-threatening consequences; or urgent intervention indicated.	Up to Week 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants who Complete all 3 EUS-RFA Treatments	Treatments delivered during Study Window 2 (Weeks 1-3), Window 3 (Weeks 5-7), and Window 4 (Weeks 9-11).	Up to Week 11
Disease-Free Survival from Diagnosis	Time from diagnosis to first clinical evidence of local or distant recurrence.	Up to Week 24
Disease-Free Survival from First Study Procedure	Time from first study procedure (delivered during Weeks 1-3) to first clinical evidence of local or distant recurrence.	Up to Week 24
Overall Survival From Diagnosis	Time from diagnosis to death.	Up to Week 24
Percentage of Participants who Report Post-Procedural Complications		Up to Week 24

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Taewoong Medical
• Investigators: Principal Investigator: Tamas A. Gonda, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Therapeutics; Drug Therapy
• Other Study ID Numbers: 22-00249

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [Tamas.Gonda@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Tamas.Gonda@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No