EUS-RFA PANCARDINAL-1 Trial (PANCARDINAL-1)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)
• Intervention / Treatment: Device: Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA); Drug: Neoadjuvant Chemotherapy (NAC)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sofia C Colon, BS; Phone Number: 713-500-6658; Email: Sofia.C.Colon@uth.tmc.edu
• Study Contact Backup: Name: Nirav Thosani, MD; Phone Number: 713-486-1350; Email: pancreasresearch@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Memorial Hermann Hospital
      • Principal Investigator: Nirav Thosani, MD, MHA
      • Sub-Investigator: Curtis Wray, MD
      • Principal Investigator: Jennifer Bailey, PhD, MA
      • Contact: Sofia C Colon, BS; Phone Number: 713-500-6658; Email: Sofia.C.Colon@uth.tmc.edu
      • Contact: Nirav Thosani, MD; Phone Number: 713-486-1350; Email: pancreasresearch@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed and histologically-confirmed PDAC by biopsy
• Permanent street address
• Consent to study participation
• Axial CT scan consistent with PDAC
• No prior chemotherapy or less than 2 months of pre-operative chemotherapy for PDAC
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria:

• Male or female patients < 18 years of age
• No permanent street address or telephone number
• Pregnant patients
• Inmates or prisoners
• Unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Neoadjuvant chemotherapy (NAC) plus endoscopic ultrasound (EUS) radiofrequency ablation (RFA)

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)].

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants who are able to complete neoadjuvant chemotherapy plus EUS-RFA and later undergo surgical tumor resection	From the time of EUS-RFA NAC intervention to the time of surgical tumor resection (about 5-6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria	Using the RECIST criteria, treatment response is categorized as follows: Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions	2 months after the initiation of chemotherapy
Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria	Using the RECIST criteria, treatment response is categorized as follows: Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions	4 months after the initiation of chemotherapy
Number of participants with post-operative complications		from the time of surgical tumor resection to 90 days following surgical tumor resection
Disease-free survival time	Disease is defined as clinical evidence of local or distant recurrence.	from the time of diagnosis to time of recurrence (or up to 5 years after diagnosis, whichever occurs first)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Nirav Thosani, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Endoscopic Ultrasound Radiofrequency ablation (EUS-RFA)
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma
• Other Study ID Numbers: HSC-MS-21-0066; R01CA277161-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No