Spots Global Cancer Trial Database for Pressure Enabled Drug Delivery By Pancreatic Retrograde Venous Infusion For Advanced Pancreatic Carcinoma

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Trial Identification

Brief Title: Pressure Enabled Drug Delivery By Pancreatic Retrograde Venous Infusion For Advanced Pancreatic Carcinoma

Official Title: Pressure Enabled Drug Delivery By Pancreatic Retrograde Venous Infusion For Advanced Pancreatic Carcinoma

Study ID: NCT04270929

Conditions

Pancreatic Adenocarcinoma

Interventions

FOLFIRI

FOLFIRINOX

TriSalus Infusion System

Study Description

Brief Summary: This is an open label, single institution, dose-escalation phase 1 study designed to assess the feasibility, safety, and efficacy of oxaliplatin administered via Pancreatic Retrograde Venous Infusion (PRVI) using Pressure Enabled Drug Delivery (PEDD) technology. Oxaliplatin PEDD-PRVI is administered with systemic FOLFIRI followed by FOLFIRINOX therapy for the treatment of patients with unresectable or metastatic pancreatic adenocarcinoma.

Detailed Description: The treatment period consists of 6 cycles. Cycles 1 and 2 involve the regional administration of oxaliplatin via PEDD-PRVI with systemic FOLFIRI. During cycles 1 and 2, patients are evaluated on days 1, 2, 4, and 8. Cycles 3 through 6 include the systemic administration of standard of care FOLFIRINOX. During cycles 3 through 6, patients are evaluated on days 1 and 8.