Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally
The purpose of this study is to perform a pilot phase II trial to evaluate the safety and efficacy of combined EUS-RFA, chemotherapy, and systemic immunotherapy (pembrolizumab) for the treatment of locally advanced unresectable and metastatic Pancreatic ductal adenocarcinoma (mPDAC).
| Condition(s) | Pancreatic Ductal Adenocarcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The purpose of this study is to perform a pilot phase II trial to evaluate the safety and efficacy of combined EUS-RFA, chemotherapy, and systemic immunotherapy (pembrolizumab) for the treatment of locally advanced unresectable and metastatic Pancreatic ductal adenocarcinoma (mPDAC). |
| Who can participate | Inclusion Criteria: * Is willing and able to comply with the protocol for the duration of the study,including undergoing treatment and scheduled visits and examinations, including follow-up * Biopsy-proven locally advanced unresectable or metastatic PDAC 1. Patients who have undergone prior resection will be excluded unless there is recurrent pancreatic tumor that is amenable to EUS-RFA. 2. If biliary metal stent is placed, during procedure of EUS-RFA, indwelling biliary metal stent will be removed during initial EUS-RFA and then replaced with plastic stent. * Mental capacity to provide informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol * Eastern Cooperative Oncology Group (ECOG) Performance stat |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | The University of Texas Health Science Center, Houston |
| Locations | Houston, Texas, United States |
| Start date | 2025-03-26 |
| NCT ID | NCT06831136 |
| Official listing | https://clinicaltrials.gov/study/NCT06831136 |