NCT06850623

Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of 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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: EXACT Therapeutics AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Acoustic Cluster Therapy	Drug: PS101; Device: Ultrasound
DRUG	Modified FOLFIRINOX	Chemotherapy

Timeline

• Start date: 2025-06-19
• Primary completion: 2026-12-15
• Completion: 2027-07-15
• First posted: 2025-02-27
• Last updated: 2026-04-03

Locations

10 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study