EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Chemotherapy
* Device: Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy plus EUS-RFA<br>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<br>* Patients will receive continuation of second or initiate third-line chemotherapy regimen at the discretion and decision of treating oncologist.<br>Device: Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA)<br>* 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.<br>* Other names: EUSRA RF Electrode;|

What is the study measuring?
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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 |