Adding acoustic cluster therapy to chemotherapy for locally advanced pancreatic cancer
A Phase 2 Study to Investigate the Efficacy and Safety of Acoustic Cluster Therapy With Modified FOLFIRINOX in Patients With Locally Advanced Pancreatic Cancer
This trial will try adding Acoustic Cluster Therapy (PS101 plus ultrasound) to modified FOLFIRINOX chemotherapy for people with locally advanced pancreatic cancer who have not had prior treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | EXACT Therapeutics AS Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 10 sites (Scottsdale, Arizona and 9 other locations) |
| Trial ID | NCT06850623 on ClinicalTrials.gov |
What this trial studies
Patients with inoperable or borderline resectable locally advanced pancreatic adenocarcinoma who have not received prior pancreatic cancer treatment will receive Acoustic Cluster Therapy (an intravenous PS101 injection followed by ultrasound to the tumor) on Day 1 of each 2-week chemotherapy cycle together with modified FOLFIRINOX. Treatment can continue for up to eight 2-week cycles while investigators monitor safety and side effects at clinic visits. Tumor response and objective efficacy will be measured by CT scans every 8 weeks. The multicenter Phase 2 trial is sponsored by EXACT Therapeutics and is being conducted at three US cancer centers.
Who should consider this trial
Good fit: Ideal candidates are adults with locally advanced or borderline resectable pancreatic adenocarcinoma who have not had prior anti-cancer treatment for their pancreas and who are fit enough to receive modified FOLFIRINOX.
Not a fit: Patients who have already received prior chemotherapy, radiation, or pancreatic surgery for their cancer, those with distant metastatic disease, or those unable to tolerate mFOLFIRINOX are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding ACT could improve chemotherapy delivery into the tumor and increase tumor shrinkage, potentially improving outcomes or making surgery possible for some patients.
How similar studies have performed: Preclinical work and early-phase trials in other tumor types suggest ultrasound-activated microbubbles can enhance drug delivery, but ACT for pancreatic cancer remains relatively novel and not yet proven in large clinical trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Scottsdale, Arizona and 9 other locations
- HonorHealth Research Institute — Scottsdale, Arizona, United States (Recruiting)
- Stanford Cancer Center Palo Alto — Stanford, California, United States (Recruiting)
- Beth Israel Deaconess Medical Center - Division of Hematology/Oncology — Boston, Massachusetts, United States (Recruiting)
- Henry Ford Centre — Detroit, Michigan, United States (Recruiting)
- Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- Brown University Cancer Institute — Providence, Rhode Island, United States (Recruiting)
- CAMBRIDGE CANCER TRIALS CENTRE-Addenbrooke's Hospital — Cambridge, Cambridge, United Kingdom (Recruiting)
- Gary Weston Centre- Imperial College Healthcare- Du Cane Road — Hammersmith, London, United Kingdom (Recruiting)
- The Royal Marsden- Downs Road — Sutton, Surrey, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.