Using EUS-RFA and chemotherapy to treat pancreatic cancer
Phase I Pilot Study of Endoscopic Ultrasound Guided RFA in Advanced Pancreatic Cancer
This study is testing if combining a special type of heat treatment with chemotherapy can help people with advanced pancreatic cancer who haven't responded to other treatments feel better and live longer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05723107 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of combining chemotherapy with endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) in patients with unresectable pancreatic ductal adenocarcinoma (PDAC). It focuses on patients who have not responded to first-line chemotherapy and have locally advanced disease without distant metastasis. The study aims to assess the effectiveness of this combination therapy in managing symptoms and potentially improving outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed PDAC who have locally advanced disease and have not responded to first-line chemotherapy.
Not a fit: Patients with evidence of distant metastasis or those with lesions that are not accessible endoscopically will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option that may improve the quality of life and outcomes for patients with advanced pancreatic cancer.
How similar studies have performed: While the combination of EUS-RFA and chemotherapy is a novel approach, similar studies have shown promise in treating other types of cancers, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- Tisch Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Tamas A. Gonda, MD — NYU Langone Health
- Study coordinator: Tamas A. Gonda, MD
- Email: Tamas.Gonda@nyulangone.org
- Phone: 212-263-3095
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.