Pancreatic Cancer
Conditions
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.
Interventions
DRUGChemotherapy
Patients will receive continuation of second or initiate third-line chemotherapy regimen at the discretion and decision of treating oncologist.
DEVICEEndoscopic 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.
Sponsors
Taewoong Medical
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants who Complete Therapy without Grade III-IV Adverse Events (AEs) as Assessed by CTCAE v. 5.0 | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants who Complete all 3 EUS-RFA Treatments | Up to Week 11 | Treatments delivered during Study Window 2 (Weeks 1-3), Window 3 (Weeks 5-7), and Window 4 (Weeks 9-11). |
| Disease-Free Survival from Diagnosis | Up to Week 24 | Time from diagnosis to first clinical evidence of local or distant recurrence. |
| Disease-Free Survival from First Study Procedure | Up to Week 24 | Time from first study procedure (delivered during Weeks 1-3) to first clinical evidence of local or distant recurrence. |
| Overall Survival From Diagnosis | Up to Week 24 | Time from diagnosis to death. |
| Percentage of Participants who Report Post-Procedural Complications | Up to Week 24 | — |
Countries
United States
Contacts
Primary ContactTamas A. Gonda, MD
Backup ContactEmil Agarunov
Outcome results
None listed