EUS-RFA PANCARDINAL-1 Trial

NCT04990609 | Recruiting Phase 2 FDA Drug FDA Device

• 2 other identifiers: HSC-MS-21-0066R01CA277161-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Endoscopic Ultrasound Radiofrequency ablation (EUS-RFA)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria

  2 months after the initiation of chemotherapy

• Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria

  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

  from the time of diagnosis to time of recurrence (or up to 5 years after diagnosis, whichever occurs first)

Study Arms (1)

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

EXPERIMENTAL

Device: Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA); Drug: Neoadjuvant Chemotherapy (NAC)

Interventions

Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA) DEVICE

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.

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

Neoadjuvant Chemotherapy (NAC) DRUG

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Interventions

Endosonography; Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Combined Modality Therapy; Therapeutics

Study Officials

• Nirav Thosani, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofia C Colon, BS

CONTACT

713-500-6658; Sofia.C.Colon@uth.tmc.edu

Nirav Thosani, MD

CONTACT

713-486-1350; pancreasresearch@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: August 4, 2021
• Study Start: August 13, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 30, 2028
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)