Actively Recruiting
A Phase 2 Study to Investigate the Efficacy and Safety of Acoustic Cluster Therapy With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer
Led by EXACT Therapeutics AS · Updated on 2026-04-03
25
Participants Needed
10
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Acoustic Cluster Therapy (ACT) combined with chemotherapy in treating patients with Locally Advanced Pancreatic Cancer (LAPC) who have not received prior treatment for their pancreatic cancer. This Phase 2 study aims to assess how well ACT, given alongside modified FOLFIRINOX chemotherapy, works for this condition. Participants receive ACT treatment, which includes the drug PS101 combined with ultrasound applied directly to the tumor, on the first day of each chemotherapy cycle. Chemotherapy with modified FOLFIRINOX is given in up to eight 2-week cycles. Patients are monitored throughout treatment for side effects and overall health. During the study, participants will have CT scans every 8 weeks to evaluate tumor response. Researchers will measure the overall response rate, tumor size changes, treatment side effects, survival rates, and potential eligibility for surgery. The trial lasts up to 24 weeks, during which safety and treatment effects are closely tracked.
CONDITIONS
Brief Title
Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Not suitable for primary curative surgery and have radiographic and pathological disease consistent with inoperable locally advanced or borderline resectable pancreatic cancer
- Suitable to receive treatment with modified FOLFIRINOX according to the Investigator's assessment
- Adults aged 18 years or older
You will not qualify if you...
- Any prior anti-cancer treatment for pancreatic cancer (e.g., chemotherapy, surgery, radiation)
- Palliative bypass procedure and bile duct stenting are allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks (8 cycles of 2 weeks each)
Participants receive Acoustic Cluster Therapy with modified FOLFIRINOX chemotherapy in up to eight 2-week cycles. Therapy includes the drug PS101 and ultrasound application to the tumor on Day 1 of each chemotherapy cycle. Participants’ well-being and side effects are assessed during treatment visits.
Visits every 2 weeks for up to 8 cycles
Duration - Up to 24 weeks from baseline
Participants undergo CT scans every 8 weeks to assess the objective efficacy of the treatment and continue safety monitoring after treatment ends.
CT scan visits approximately every 8 weeks
Trial Site Locations
Total: 10 locations
1
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Stanford Cancer Center Palo Alto
Stanford, California, United States, 94305
Actively Recruiting
3
Beth Israel Deaconess Medical Center - Division of Hematology/Oncology
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Henry Ford Centre
Detroit, Michigan, United States, 48202
Actively Recruiting
5
Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
6
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
7
Brown University Cancer Institute
Providence, Rhode Island, United States, 02906
Actively Recruiting
8
CAMBRIDGE CANCER TRIALS CENTRE-Addenbrooke's Hospital
Cambridge, Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
9
Gary Weston Centre- Imperial College Healthcare- Du Cane Road
Hammersmith, London, United Kingdom, W12 0HS
Actively Recruiting
10
The Royal Marsden- Downs Road
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here