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

ConditionLocally Advanced Pancreatic Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEXACT Therapeutics AS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Acoustic Cluster Therapy

    Combination product

    Drug: PS101; Device: Ultrasound

  • Modified FOLFIRINOX

    Drug

    Chemotherapy

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Acoustic Cluster Therapy (ACT) with mFOLFIRINOXExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
From baseline to end of treatment (up to Week 24)

Secondary outcomes

1

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.

Time frame
From enrollment up to week 24
2

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.

Time frame
From baseline up to week 24
3

Median OS and proportion of participants alive at 6 months.

Time frame
from baseline to week 24
4

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

Time frame
from baseline to week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EXACT Therapeutics AS

Lead sponsor

Source ClinicalTrials.gov
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