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2025-06-19
2026-12-15
2027-07-15
25
NCT06850623
EXACT Therapeutics AS
EXACT Therapeutics AS
INTERVENTIONAL
Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-01-15 | N/A | 2025-08-29 |
2025-02-21 | N/A | 2025-09-05 |
2025-02-27 | N/A | 2025-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Acoustic Cluster Therapy (ACT) with mFOLFIRINOX | COMBINATION_PRODUCT: Acoustic Cluster Therapy
DRUG: Modified FOLFIRINOX
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Chief Medical Officer Phone Number: +47 46 86 39 89 Email: clinical.trials@exact-tx.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
