Clinical trial NCT06850623: Acoustic Cluster Therapy (ACT) with Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer
Official title: A Phase 2 Study to Investigate the Efficacy and Safety of Acoustic Cluster Therapy with Modified FOLFIRINOX in Patients with Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Locally Advanced Pancreatic Adenocarcinoma
Keywords: pancreatic cancer
PS101
ultrasound
microbubbles
Pancreatic Ductal Carcinoma
locally advanced pancreatic cancer
first line treatment
chemotherapy
Acoustic Cluster Therapy
mFOLFIRINOX
Lead sponsor: EXACT Therapeutics AS
Sponsor class: INDUSTRY
First posted: 2025-02-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: From baseline to end of treatment (up to Week 24)
Secondary outcomes:
measure: 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.
timeFrame: From enrollment up to week 24
measure: 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.
timeFrame: From baseline up to week 24
measure: Median OS and proportion of participants alive at 6 months.
timeFrame: from baseline to week 24
measure: The proportion of participants becoming eligible for resection as determined by local multidisciplinary team review
timeFrame: from baseline to week 24
Other outcomes:
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