NCT06850623

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
14mo left

Started Jun 2025

Geographic Reach
2 countries

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Jun 2025Jul 2027

First Submitted

Initial submission to the registry

January 15, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

June 19, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

January 15, 2025

Last Update Submit

March 2, 2026

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Keywords

pancreatic cancerPS101ultrasoundmicrobubblesPancreatic Ductal Carcinomalocally advanced pancreatic cancerfirst line treatmentchemotherapyAcoustic Cluster TherapymFOLFIRINOX

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (4)

  • 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.

    From enrollment up to week 24

  • 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.

    From baseline up to week 24

  • Median OS and proportion of participants alive at 6 months.

    from baseline to week 24

  • The proportion of participants becoming eligible for resection as determined by local multidisciplinary team review

    from baseline to week 24

Study Arms (1)

Acoustic Cluster Therapy (ACT) with mFOLFIRINOX

EXPERIMENTAL
Combination Product: Acoustic Cluster TherapyDrug: Modified FOLFIRINOX

Interventions

Acoustic Cluster TherapyCOMBINATION_PRODUCT

Drug: PS101; Device: Ultrasound

Acoustic Cluster Therapy (ACT) with mFOLFIRINOX
Modified FOLFIRINOXDRUG

Chemotherapy

Acoustic Cluster Therapy (ACT) with mFOLFIRINOX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

RECRUITING

Stanford Cancer Center Palo Alto

Stanford, California, 94305, United States

RECRUITING

Beth Israel Deaconess Medical Center - Division of Hematology/Oncology

Boston, Massachusetts, 02215, United States

ACTIVE NOT RECRUITING

Henry Ford Centre

Detroit, Michigan, 48202, United States

RECRUITING

Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Brown University Cancer Institute

Providence, Rhode Island, 02906, United States

RECRUITING

CAMBRIDGE CANCER TRIALS CENTRE-Addenbrooke's Hospital

Cambridge, Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Gary Weston Centre- Imperial College Healthcare- Du Cane Road

Hammersmith, London, W12 0HS, United Kingdom

RECRUITING

The Royal Marsden- Downs Road

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsCarcinoma, Pancreatic Ductal

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesCarcinoma, DuctalAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Ductal, Lobular, and Medullary

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2025

First Posted

February 27, 2025

Study Start

June 19, 2025

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

July 15, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)US(7)