EUS-RFA PANCARDINAL-1 Trial

Phase 2

Recruiting

• Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)
• Interventions: Device: Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA); Drug: Neoadjuvant Chemotherapy (NAC)

• Registration Number: NCT04990609
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-08-04
• Study Start: 2021-08-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-12-01
• Study Completion: 2028-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant chemotherapy (NAC) plus endoscopic ultrasound (EUS) radiofrequency ablation (RFA)	Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)	-
Neoadjuvant chemotherapy (NAC) plus endoscopic ultrasound (EUS) radiofrequency ablation (RFA)	Neoadjuvant Chemotherapy (NAC)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Disease-free survival time	from the time of diagnosis to time of recurrence (or up to 5 years after diagnosis, whichever occurs first)	Disease is defined as clinical evidence of local or distant recurrence.
Number of participants with post-operative complications	from the time of surgical tumor resection to 90 days following surgical tumor resection
Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria	4 months after the initiation of chemotherapy	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

Trial Locations

Locations (1)

Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States