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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment25 people
  • Recruiting US sites7
  • SponsorEXACT Therapeutics AS
  • RegistryNCT06850623

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer: a one-minute explainerNCT068506231 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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.

You cannot join if

  • Any prior anti-cancer treatment for pancreatic cancer (e.g. chemotherapy, surgery, radiation). Palliative bypass procedure and bile duct stenting are allowed.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • Acoustic Cluster Therapy (Combination Product): Drug: PS101; Device: Ultrasound
  • Modified FOLFIRINOX (Drug): Chemotherapy

The study

Treatment groups

Na · Single Group · masking: None

Acoustic Cluster Therapy (ACT) with mFOLFIRINOX (Experimental)

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • CT scans: Part of the study plan

Goals

What the study measures

Main goals

  • 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))

Other goals

  • Overall summary of TEAEs including number and percentage of participants with at least one TEAE. TEAEs will be summarized by System Organ Class and Preferred Term. TEAEs will be summarized by severity and causality.
  • Change in maximum tumor diameter and volume summarized as the largest or the smallest percentage change from baseline. Independent central image review based on RECIST 1.1 criteria will be the primary analysis.
  • Median OS and proportion of participants alive at 6 months.
  • The proportion of participants becoming eligible for resection as determined by local multidisciplinary team review

Planned enrollment: 25 (estimated).

Where

Recruiting US sites

  • HonorHealth Research Institute, Scottsdale, Arizona
  • Stanford Cancer Center Palo Alto, Stanford, California
  • Beth Israel Deaconess Medical Center - Division of Hematology/Oncology, Boston, Massachusetts
  • Henry Ford Centre, Detroit, Michigan
  • Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania
  • Allegheny General Hospital, Pittsburgh, Pennsylvania
  • Brown University Cancer Institute, Providence, Rhode Island

3 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 12, 2026. Public record; not medical advice.

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