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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Patients will receive continuation of second or initiate third-line chemotherapy regimen at the discretion and decision of treating oncologist.
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.
Tisch Hospital
New York, New York, United States
RECRUITINGPercentage 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.
Time frame: Up to Week 15
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).
Time frame: Up to Week 11
Disease-Free Survival from Diagnosis
Time from diagnosis to first clinical evidence of local or distant recurrence.
Time frame: 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.
Time frame: Up to Week 24
Overall Survival From Diagnosis
Time from diagnosis to death.
Time frame: Up to Week 24
Percentage of Participants who Report Post-Procedural Complications
Time frame: Up to Week 24
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