EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)

NCT05723107 | Recruiting Phase 1 FDA Device

• 1 other identifier: 22-00249
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of Participants who Complete all 3 EUS-RFA Treatments

  Up to Week 11

• Disease-Free Survival from Diagnosis

  Up to Week 24

• Disease-Free Survival from First Study Procedure

  Up to Week 24

• Overall Survival From Diagnosis

  Up to Week 24

• Percentage of Participants who Report Post-Procedural Complications

  Up to Week 24

Study Arms (1)

Chemotherapy plus EUS-RFA

EXPERIMENTAL

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

Interventions

Chemotherapy DRUG

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

Chemotherapy plus EUS-RFA

Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA) DEVICE

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.

Also known as: EUSRA RF Electrode

Chemotherapy plus EUS-RFA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Taewoong Medical: collaborator

Study Sites (1)

Tisch Hospital

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Tamas A. Gonda, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamas A. Gonda, MD

CONTACT

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

Emil Agarunov

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 10, 2023
• Study Start: March 31, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)