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

NCT ID: NCT06850623

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-19

Study Completion Date

2027-07-15

Brief Summary

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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

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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

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Locally Advanced Pancreatic Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acoustic Cluster Therapy (ACT) with mFOLFIRINOX

Group Type EXPERIMENTAL

Acoustic Cluster Therapy

Intervention Type COMBINATION_PRODUCT

Drug: PS101; Device: Ultrasound

Modified FOLFIRINOX

Intervention Type DRUG

Chemotherapy

Interventions

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Acoustic Cluster Therapy

Drug: PS101; Device: Ultrasound

Intervention Type COMBINATION_PRODUCT

Modified FOLFIRINOX

Chemotherapy

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EXACT Therapeutics AS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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HonorHealth Research Institute

Scottsdale, Arizona, United States

Site Status RECRUITING

Henry Ford Centre

Detroit, Michigan, United States

Site Status RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Brown University Cancer Institute

Providence, Rhode Island, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Chief Medical Officer

Role: CONTACT

+47 46 86 39 89

Facility Contacts

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Amy Malensek

Role: primary

(+1) (480) 323 1364

Amy Clinical Research Nurse;

Role: backup

(+1) (480)-323-1364

Bethanny Adams

Role: primary

+1 313-556-8107

Paul Renz, DO

Role: primary

+1-412-359-3400

Alexander Raufi, MD

Role: primary

+1 (844) 222-2881

Stephen Sando

Role: backup

+1-(401) 606-6602

Other Identifiers

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EX-2-P2-2023

Identifier Type: -

Identifier Source: org_study_id

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