EUS-RFA PANCARDINAL-1 Trial

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 13, 2021

Primary Completion Date

December 1, 2026

Study Completion Date

May 30, 2028

Conditions
Pancreatic Ductal Adenocarcinoma (PDAC)
Interventions
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 \[possible regimens are either mFOLFIRINOX or Gemcitabine Nab-Paclitaxel +/- Cisplatin (GemAbraxane)\].

Trial Locations (1)

77030

RECRUITING

Memorial Hermann Hospital, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

The University of Texas Health Science Center, Houston

OTHER