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

Trial ID: NCT04990609

Interventional - Phase 2 - Recruiting

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)

Interventions

• Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)
• Neoadjuvant Chemotherapy (NAC)

Eligibility

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

Sponsor

The University of Texas Health Science Center, Houston, National Cancer Institute (NCI)

Source: ClinicalTrials.gov

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