NCT04990609

EUS-RFA PANCARDINAL-1 Trial

A Single-arm Phase II Study to Evaluate the Safety and Efficacy of Combination Systematic Chemotherapy and Multiple Rounds of Endoscopic Ultrasound-guided Radiofrequency Ablation in Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to determine the feasibility, tolerability, and treatment effect of endoscopic ultrasound (EUS) radiofrequency ablation (RFA) plus standard-of-care neoadjuvant chemotherapy (NAC) in the treatment of pancreatic ductal adenocarcinoma (PDAC). Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) and neoadjuvant chemotherapy (NAC) will be performed before tumor resection surgery, with the goal of shrinking a tumor or stopping the spread of cancer so that surgery might be less invasive and more effective.

Conditions

• Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions

Type	Name	Description
DEVICE	Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)	Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) consists of the application of an alternating current with a frequency of 350-500 kilohertz (kHz) to the target tissue via a special electrode located at the tip of an echoendoscope. The alternating current causes the vibratory movement of ionic particles in the abutting and adjoining tissue and results in the generation of heat. However, RFA induces not only local disruption of the tumor by heat, but it also produces localized coagulation necrosis of the tumor; which induces the release of large amounts of cellular debris. This cellular debris represents a source of tumor antigens that can trigger a host adaptive immune response against the tumor.
DRUG	Neoadjuvant Chemotherapy (NAC)	The NAC regimen will be determined clinically by the participant's physician \[possible regimens are either mFOLFIRINOX or Gemcitabine Nab-Paclitaxel +/- Cisplatin (GemAbraxane)\].

Timeline

• Start date: 2021-08-13
• Primary completion: 2026-12-01
• Completion: 2028-05-30
• First posted: 2021-08-04
• Last updated: 2025-05-21

Locations

1 site across 1 country: United States

Regulatory

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