RecruitingPhase 1NCT05723107

EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)

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


Sponsor

NYU Langone Health

Enrollment

15 participants

Start Date

Mar 31, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a procedure called endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) — where a probe is inserted through an endoscope to deliver heat energy directly into a pancreatic tumor — for patients with locally advanced pancreatic ductal adenocarcinoma (PDAC, the most common type of pancreatic cancer) that cannot be surgically removed and has not responded to first-line chemotherapy. **You may be eligible if...** - You have confirmed pancreatic cancer (PDAC) that is locally advanced but has not spread to distant organs - Your tumor is between 1 and 4 cm in size and accessible by endoscope - Your cancer did not respond or progressed on first-line chemotherapy - Your general health is reasonable (ECOG 0-2) **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body (metastatic) - The tumor cannot be reached safely by endoscope - You are pregnant - Your tumor is smaller than 1 cm or larger than 4 cm Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Tisch Hospital

New York, New York, United States

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NCT05723107


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