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NCT Number: NCT05723107

EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tisch Hospital

New York, 10016, United States

Location status: Recruiting

Location contact

Tamas A. Gonda, MD

CONTACT

[email protected]

212-263-3095

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

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)

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.

Other names: EUSRA RF Electrode

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Percentage of Participants who Complete all 3 EUS-RFA Treatments

    Time frame: Up to Week 11

    Treatments delivered during Study Window 2 (Weeks 1-3), Window 3 (Weeks 5-7), and Window 4 (Weeks 9-11).

  2. Disease-Free Survival from Diagnosis

    Time frame: Up to Week 24

    Time from diagnosis to first clinical evidence of local or distant recurrence.

  3. Disease-Free Survival from First Study Procedure

    Time frame: Up to Week 24

    Time from first study procedure (delivered during Weeks 1-3) to first clinical evidence of local or distant recurrence.

  4. Overall Survival From Diagnosis

    Time frame: Up to Week 24

    Time from diagnosis to death.

  5. Percentage of Participants who Report Post-Procedural Complications

    Time frame: Up to Week 24

Study contacts

Contact information is provided by the study sponsor or research team.

Emil Agarunov

CONTACT

[email protected]

212-263-3095

Tamas A. Gonda, MD

CONTACT

[email protected]

212-263-3095

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Taewoong Medical

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Feb 10, 2023
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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