Sonoporation and Chemotherapy for the Treatment of Pancreatic Cancer

Summary

This phase I/II trial studies the effect of sonoporation in addition to standard of care chemotherapy in treating patients with pancreatic cancer. Sonoporation is a novel method that uses ultrasound and microbubbles to increase therapeutic effect by increasing uptake or enhance sensitization. Sonoporation together with chemotherapy may work better in treating patients with pancreatic cancer compared to chemotherapy alone.

Conditions

• Locally Advanced Pancreatic Ductal Adenocarcinoma
• Metastatic Pancreatic Ductal Adenocarcinoma
• Stage II Pancreatic Cancer AJCC v8
• Stage IIA Pancreatic Cancer AJCC v8
• Stage IIB Pancreatic Cancer AJCC v8
• Stage III Pancreatic Cancer AJCC v8
• Stage IV Pancreatic Cancer AJCC v8
• Unresectable Pancreatic Ductal Adenocarcinoma

Interventions

DRUG

Gemcitabine Hydrochloride

Given IV

DRUG

Nab-paclitaxel

Given IV

DRUG

Fluorouracil

Given IV

DRUG

Irinotecan Hydrochloride

Given IV

DRUG

Leucovorin Calcium

Given IV

DRUG

Oxaliplatin

Given IV

OTHER

Perflubutane Microbubble

Oxaliplatin

PROCEDURE

Contrast-Enhanced Ultrasound

Undergo CEUS

OTHER

Quality-of-Life Assessment

Ancillary studies

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Flemming Forsberg

  lead OTHER

Principal Investigators

• Flemming Forsberg, PhD · Thomas Jefferson University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-06

Primary Completion

2025-10-31

Completion

2026-02-28

FDA Drug

Yes

Countries

• United States
• Norway

Study Locations