NCT06831136

Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally Advanced Unresectable and Metastatic Pancreatic Duct Adenocarcinoma

Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally Advanced Unresectable and Metastatic Pancreatic Duct Adenocarcinoma; a Phase II Trial PANcreas CAncer RaDIofrequeNcy AbLation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Neoadjuvant Chemotherapy (NAC)	Participant will undergo 8 weeks of NAC (treating physician's choice). Possible regimens are either mFOLFIRINOX or NALIRIFOX or Gemcitabine Nab-Paclitaxel ± Cisplatin (GA+/-Cisplatin) or Capecitabine (Xeloda).
DRUG	Immunotherapy (pembrolizumab)	2-12 weeks after initial chemotherapy and after the first EUS-RFA treatment, patients will receive 400 mg every 6 weeks of pembrolizumab via infusion. Participants will be administered standard of care chemotherapy and pembrolizumab every 6 weeks.
DEVICE	Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA)	After 2-12 weeks of chemotherapy, patients will undergo EUS-RFA treatment 1 session every 6 weeks. Each RFA treatment will be for up to 5 cycles at 30W for 20 seconds or until there is an increase in measured impedance. After the 5th EUS-RFA, if there is clinical benefit, then patients will continue with EUS-RFA treatments until no active tumor is seen. During each session, the therapeutic gastroenterologist will evaluate if there is any tumor to undergo RFA. If no active tumor seen, then will abort RFA

Timeline

• Start date: 2025-03-26
• Primary completion: 2028-01-20
• Completion: 2030-01-20
• First posted: 2025-02-17
• Last updated: 2025-09-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study