RecruitingPhase 1

EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)

United States15 participantsStarted 2023-03-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of Participants who Complete Therapy without Grade III-IV Adverse Events (AEs) as Assessed by CTCAE v. 5.0

Timeframe: Up to Week 15

Trial details

NCT IDNCT05723107

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11

Contact for this trial

Tamas A. Gonda, MD

212-263-3095 Tamas.Gonda@nyulangone.org

View on ClinicalTrials.gov More Pancreatic Cancer trials