RecruitingRecruiting
Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer
NCT06850623 · EXACT Therapeutics AS
In plain English
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Official title
A Phase 2 Study to Investigate the Efficacy and Safety of Acoustic Cluster Therapy With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer
About this study
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.
Eligibility criteria
Inclusion Criteria:
* Not deemed suitable for primary curative surgery and have radiographic and pathological disease consistent with inoperable LAPC or borderline resectable pancreatic cancer.
* Suitable to receive treatment with mFOLFIRINOX according to the Investigator's assessment.
Exclusion Criteria:
• Any prior anti-cancer treatment for pancreatic cancer (e.g. chemotherapy, surgery, radiation). Palliative bypass procedure and bile duct stenting are allowed.
Study design
Enrollment target: 25 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-06-19
Estimated completion: 2027-07-15
Last updated: 2026-04-03
Interventions
Combination Product: Acoustic Cluster TherapyDrug: Modified FOLFIRINOX
Primary outcomes
- • 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. (From baseline to end of treatment (up to Week 24))
Sponsor
EXACT Therapeutics AS · industry
All locations (10)
HonorHealth Research InstituteRecruiting
Scottsdale, Arizona, United States
Stanford Cancer Center Palo AltoRecruiting
Stanford, California, United States
Beth Israel Deaconess Medical Center - Division of Hematology/OncologyRecruiting
Boston, Massachusetts, United States
Henry Ford CentreRecruiting
Detroit, Michigan, United States
Sidney Kimmel Cancer Center, Thomas Jefferson University HospitalRecruiting
Philadelphia, Pennsylvania, United States
Allegheny General HospitalRecruiting
Pittsburgh, Pennsylvania, United States
Brown University Cancer InstituteRecruiting
Providence, Rhode Island, United States
CAMBRIDGE CANCER TRIALS CENTRE-Addenbrooke's HospitalRecruiting
Cambridge, Cambridge, United Kingdom
Gary Weston Centre- Imperial College Healthcare- Du Cane RoadRecruiting
Hammersmith, London, United Kingdom
The Royal Marsden- Downs RoadRecruiting
Sutton, Surrey, United Kingdom