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NCT06850623PHASE2Recruiting

Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer

EXACT Therapeutics AS

Start Date

6/19/2025

Completion Date

7/15/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

COMBINATION_PRODUCT

Acoustic Cluster Therapy

DRUG

Modified FOLFIRINOX

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Conditions

Locally Advanced Pancreatic Adenocarcinoma

Locations

HonorHealth Research Institute

Scottsdale, Arizona 85258

United States

Stanford Cancer Center Palo Alto

Stanford, California 94305

United States

Beth Israel Deaconess Medical Center - Division of Hematology/Oncology

Boston, Massachusetts 02215

United States

Henry Ford Centre

Detroit, Michigan 48202

United States

Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital

Philadelphia, Pennsylvania 19107

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania 15212

United States

Brown University Cancer Institute

Providence, Rhode Island 02906

United States

CAMBRIDGE CANCER TRIALS CENTRE-Addenbrooke's Hospital

Cambridge, Cambridge CB2 0QQ

United Kingdom

Gary Weston Centre- Imperial College Healthcare- Du Cane Road

Hammersmith, London W12 0HS

United Kingdom

The Royal Marsden- Downs Road

Sutton, Surrey SM2 5PT

United Kingdom