RecruitingPhase 2NCT04990609

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

Sponsor

The University of Texas Health Science Center, Houston

Enrollment

60 participants

Start Date

Aug 13, 2021

Study Type

INTERVENTIONAL

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a procedure called EUS-RFA (endoscopic ultrasound guided radiofrequency ablation — using heat via a thin tube to destroy tumor tissue) in patients with pancreatic cancer, to see if it can improve outcomes when combined with other treatments. **You may be eligible if...** - You have confirmed pancreatic cancer (PDAC) proven by biopsy - You have had a CT scan consistent with pancreatic cancer - You have had no prior chemotherapy, or less than 2 months of pre-surgery chemotherapy - You are in reasonably good health (ECOG 0–2) - You are 18 or older - You have a permanent address and can be contacted **You may NOT be eligible if...** - You are under 18 - You are pregnant - You are a prisoner or inmate - You are unable to provide informed consent - You do not have a permanent address or phone number Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEndoscopic 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.

DRUGNeoadjuvant Chemotherapy (NAC)

The NAC regimen will be determined clinically by the participant's physician \[possible regimens are either mFOLFIRINOX or Gemcitabine Nab-Paclitaxel +/- Cisplatin (GemAbraxane)\].

Locations(1)

Memorial Hermann Hospital

Houston, Texas, United States

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NCT04990609

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