Sonoporation and Chemotherapy for the Treatment of Pancreatic Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Flemming Forsberg
Study ID
NCT04821284
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine Hydrochloride — DRUG
    Given IV
  • Nab-paclitaxel — DRUG
    Given IV
  • Fluorouracil — DRUG
    Given IV
  • Irinotecan Hydrochloride — DRUG
    Given IV
  • Leucovorin Calcium — DRUG
    Given IV
  • Oxaliplatin — DRUG
    Given IV
  • Perflubutane Microbubble — OTHER
    Oxaliplatin
  • Contrast-Enhanced Ultrasound — PROCEDURE
    Undergo CEUS
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI

Study Details

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.

Key Dates

Start date
Dec 6, 2021
Status verified
Sep 2025
Primary completion
Oct 31, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (sonazoid, ultrasound, chemotherapy)
    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 also receive sonazoid IV over 20 minutes and undergo CEUS. Patients undergo CT or PET/CT or MRI during screening and as clinically indicated on study.
  • Active Comparator: Arm II (chemotherapy)
    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.

Primary Outcome Measure

Progression-free survival [ Time Frame: Up to 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

Find similar trials in Philadelphia, PA

By research site
Sidney Kimmel Cancer Center at Thomas Jefferson University· Philadelphia, PA

Related Studies