Trials / Active Not Recruiting

Active Not RecruitingNCT04821284

Sonoporation and Chemotherapy for the Treatment of Pancreatic Cancer

Optimizing Ultrasound Enhanced Delivery of Therapeutics

Status: Active Not Recruiting
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 120 (estimated)

Sponsor: Flemming Forsberg · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the safety and therapeutic efficacy of sonoporation on pancreatic ductal adenocarcinoma (PDAC) standard of care (SoC) treatment based on local progression-free and overall survival with the main endpoint being an increase in median progression-free survival of subjects by 8.7 months in the sonoporation group relative to controls. SECONDARY OBJECTIVES: I. To evaluate the effect of sonoporation on the median time to treatment failure (TTF) (in percent). II. To evaluate the effect of sonoporation on the number of chemotherapy cycles subjects can undergo. III. To evaluate the effect of sonoporation on tumor volume measured by clinical diagnostic ultrasound. IV. To evaluate the effect of sonoporation on tumor perfusion using contrast enhanced ultrasound (CEUS) - specifically harmonic imaging (HI) and subharmonic imaging (SHI). V. To evaluate the effect of sonoporation on tumor interstitial fluid pressures using subharmonic aided pressure estimation (SHAPE). VI. To evaluate the effect of sonoporation on tumor volume using clinical diagnostic computed tomography (CT). VII. To evaluate the effect of sonoporation on tumor stiffness using clinical ultrasound shear wave elastography (SWE). VIII. To evaluate the effect of sonoporation on serum CA 19-9 concentrations. IX. Clinical benefit response, which is a measure of clinical improvement based on analgesic consumption, Eastern Cooperative Oncology Group (ECOG) performance status, and weight change. X. To evaluate the effect of sonoporation on patient quality of life. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive standard of care chemotherapy consisting of gemcitabine hydrochloride and nab-paclitaxel intravenously (IV) over 60 minutes on days 1, 8 and 15 OR fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (FOLFIRINOX) IV on days 1 and 2. Treatments repeat every 28 days for up to 3 cycles for gemcitabine and nab-paclitaxel, and every 14 days for up to 7 cycles for FOLFIRINOX in the absence of disease progression or unacceptable toxicity. Patients also receive sonazoid IV over 20 minutes and undergo CEUS. Patients undergo computed tomography (CT) or positron emission tomography (PET)/CT or magnetic resonance imaging (MRI) during screening and as clinically indicated on study. ARM II: Patients receive standard of care chemotherapy consisting of gemcitabine hydrochloride and nab-paclitaxel IV over 60 minutes on days 1, 8 and 15 OR FOLFIRINOX IV on days 1 and 2. Treatments repeat every 28 days for up to 3 cycles for gemcitabine and nab-paclitaxel, and every 14 days for up to 7 cycles for FOLFIRINOX in the absence of disease progression or unacceptable toxicity. Patients undergo CT or PET/CT or MRI during screening and as clinically indicated on study. After completion of study treatment, patients are followed up every 3 months.

Conditions

Interventions

Type	Name	Description
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

Timeline

Start date: 2021-12-06
Primary completion: 2025-10-31
Completion: 2026-02-28
First posted: 2021-03-29
Last updated: 2025-11-04

Locations

2 sites across 2 countries: United States, Norway

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04821284. Inclusion in this directory is not an endorsement.