EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)
NCT ID: NCT05723107
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
15 participants
INTERVENTIONAL
2023-03-31
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Endoscopically non-accessible mass
* Pregnant patients
* Inability to provide informed consent
* Lesions \<1cm, or \>4cm in greatest diameter
18 Years
ALL
No
Sponsors
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Taewoong Medical
UNKNOWN
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Tamas A. Gonda, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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Tisch Hospital
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-00249
Identifier Type: -
Identifier Source: org_study_id
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