---
title: EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)
nct_id: NCT05723107
overall_status: RECRUITING
phase: PHASE1
sponsor: NYU Langone Health
study_type: INTERVENTIONAL
primary_condition: Pancreatic Cancer
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05723107.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05723107"
ct_last_update_post_date: 2025-11-28
last_seen_at: "2026-05-12T06:32:52.613Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)

**Official Title:** Phase I Pilot Study of Endoscopic Ultrasound Guided RFA in Advanced Pancreatic Cancer

**NCT ID:** [NCT05723107](https://clinicaltrials.gov/study/NCT05723107)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 15
- **Lead Sponsor:** NYU Langone Health
- **Collaborators:** Taewoong Medical
- **Conditions:** Pancreatic Cancer
- **Start Date:** 2023-03-31
- **Completion Date:** 2028-03
- **CT.gov Last Update:** 2025-11-28

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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).

## Interventions

- **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.

## Primary Outcomes

- **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

- **Percentage of Participants who Complete all 3 EUS-RFA Treatments** _(time frame: Up to Week 11)_
- **Disease-Free Survival from Diagnosis** _(time frame: Up to Week 24)_
- **Disease-Free Survival from First Study Procedure** _(time frame: Up to Week 24)_
- **Overall Survival From Diagnosis** _(time frame: Up to Week 24)_
- **Percentage of Participants who Report Post-Procedural Complications** _(time frame: Up to Week 24)_

## Locations (1)

- Tisch Hospital, New York, New York, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.tisch hospital|new york|new york|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT05723107*  
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