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NCT Number: NCT06850623

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.

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Key information

Conditions

Locally Advanced Pancreatic Adenocarcinoma Adenocarcinoma Carcinoma Carcinoma, Ductal Carcinoma, Pancreatic Ductal Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CAMBRIDGE CANCER TRIALS CENTRE-Addenbrooke's Hospital, Cambridge, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acoustic Cluster Therapy

Combination Product

Drug: PS101; Device: Ultrasound

Modified FOLFIRINOX

Drug

Chemotherapy

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

Sponsors and collaborators

Lead sponsor

EXACT Therapeutics AS

Industry

Registry information

Official study 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

Acronym: ENACT

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 27, 2025
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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