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

Phase 2

Not yet recruiting

• Conditions: Locally Advanced Pancreatic Adenocarcinoma
• Interventions: Combination Product: Acoustic Cluster Therapy; Drug: Modified FOLFIRINOX

• Registration Number: NCT06850623
• Lead Sponsor: EXACT Therapeutics AS

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-02-21
• Last Update Submitted: 2025-02-21
• Study First Posted: 2025-02-27
• Last Update Posted: 2025-02-27
• Study Start: 2025-03-01
• Primary Completion: 2026-12-15
• Study Completion: 2027-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acoustic Cluster Therapy (ACT) with mFOLFIRINOX	Acoustic Cluster Therapy	-
Acoustic Cluster Therapy (ACT) with mFOLFIRINOX	Modified FOLFIRINOX	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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