A Phase 2 Study to Investigate the Efficacy and Safety of Acoustic Cluster Therapy With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer
Summary
The purpose of the study is to assess the efficacy and safety of Acoustic Cluster Therapy (ACT) when given in addition to chemotherapy for treatment of Locally Advanced Pancreatic Cancer.
Detailed description
Patients with Locally Advanced Pancreatic Cancer who have not received prior treatment to their pancreatic cancer will receive ACT treatment (the drug PS101 and ultrasound application to the tumor) with up to eight 2-week cycles of modified FOLFIRINOX chemotherapy. ACT treatment will be given on Day 1 of each cycle of chemotherapy. Patients' well-being and side effects will be assessed at the same visits. The objective efficacy of the treatment will be assessed by CT scans every 8 weeks.
Arms & interventions
- Combination ProductAcoustic Cluster Therapy
Drug: PS101; Device: Ultrasound
- DrugModified FOLFIRINOX
Chemotherapy
Outcome measures
Primary
ORR (Overall response rate), defined as the number of participants with measurable disease at baseline who have a confirmed Complete Response or confirmed Partial Response according to RECIST Version 1.1.
Time frame: From baseline to end of treatment (up to Week 24)
Secondary
Overall summary of TEAEs including number and percentage of participants with at least one TEAE. TEAEs will be summarized by System Organ Class and Preferred Term. TEAEs will be summarized by severity and causality.
Time frame: From enrollment up to week 24
Change in maximum tumor diameter and volume summarized as the largest or the smallest percentage change from baseline. Independent central image review based on RECIST 1.1 criteria will be the primary analysis.
Time frame: From baseline up to week 24
Median OS and proportion of participants alive at 6 months.
Time frame: from baseline to week 24
The proportion of participants becoming eligible for resection as determined by local multidisciplinary team review
Time frame: from baseline to week 24
Eligibility criteria
Study locations (7)
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Stanford Cancer Center Palo Alto
Stanford, California, 94305
Beth Israel Deaconess Medical Center - Division of Hematology/Oncology
Boston, Massachusetts, 02215
Henry Ford Centre
Detroit, Michigan, 48202
Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Brown University Cancer Institute
Providence, Rhode Island, 02906