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

Last updated: March 2, 2026
Sponsor: EXACT Therapeutics AS
Overall Status: Active - Recruiting

Phase

2

Condition

Digestive System Neoplasms

Treatment

Modified FOLFIRINOX

Acoustic Cluster Therapy

Clinical Study ID

NCT06850623
EX-2-P2-2023
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Not deemed suitable for primary curative surgery and have radiographic andpathological disease consistent with inoperable LAPC or borderline resectablepancreatic cancer.

  • Suitable to receive treatment with mFOLFIRINOX according to the Investigator'sassessment.

Exclusion

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

Total Participants: 25
Treatment Group(s): 2
Primary Treatment: Modified FOLFIRINOX
Phase: 2
Study Start date:
June 19, 2025
Estimated Completion Date:
July 15, 2027

Study 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.

Connect with a study center

  • CAMBRIDGE CANCER TRIALS CENTRE-Addenbrooke's Hospital

    Cambridge, Cambridge CB2 0QQ
    United Kingdom

    Active - Recruiting

  • CAMBRIDGE CANCER TRIALS CENTRE-Addenbrooke's Hospital

    Cambridge 2653941, Cambridge CB2 0QQ
    United Kingdom

    Site Not Available

  • Gary Weston Centre- Imperial College Healthcare- Du Cane Road

    Hammersmith, London W12 0HS
    United Kingdom

    Active - Recruiting

  • Gary Weston Centre- Imperial College Healthcare- Du Cane Road

    Hammersmith 2647567, London W12 0HS
    United Kingdom

    Site Not Available

  • The Royal Marsden- Downs Road

    Sutton, Surrey SM2 5PT
    United Kingdom

    Active - Recruiting

  • The Royal Marsden- Downs Road

    Sutton 2636503, Surrey SM2 5PT
    United Kingdom

    Site Not Available

  • HonorHealth Research Institute

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • HonorHealth Research Institute

    Scottsdale 5313457, Arizona 5551752 85258
    United States

    Site Not Available

  • Stanford Cancer Center Palo Alto

    Stanford, California 94305
    United States

    Active - Recruiting

  • Stanford Cancer Center Palo Alto

    Stanford 5398563, California 5332921 94305
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center - Division of Hematology/Oncology

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center - Division of Hematology/Oncology

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Henry Ford Centre

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Henry Ford Centre

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh 5206379, Pennsylvania 6254927 15212
    United States

    Site Not Available

  • Brown University Cancer Institute

    Providence, Rhode Island 02906
    United States

    Active - Recruiting

  • Brown University Cancer Institute

    Providence 5224151, Rhode Island 5224323 02906
    United States

    Site Not Available

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