EUS-RFA PANCARDINAL-1 Trial

Sponsor: The University of Texas Health Science Center, Houston

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04990609

Patient View

The EUS-RFA PANCARDINAL-1 Trial evaluates the feasibility and effects of combining EUS-guided RFA with NAC in PDAC treatment. Eligible participants must have confirmed PDAC, a permanent address, and meet specific health criteria. Interventions include EUS-RFA, which disrupts tumors and may trigger immune responses, and NAC, with regimens like mFOLFIRINOX or GemAbraxane.

Patient Parameters

Program Overview

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 Criteria

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

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