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Recruiting NCT06850623

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

Phase II Interventional Locally Advanced Pancreatic Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acoustic Cluster Therapy, Modified FOLFIRINOX.
Who it may be relevant to
Registry conditions: Locally Advanced Pancreatic Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Combination product Acoustic Cluster Therapy
    Drug: PS101; Device: Ultrasound
  • Drug Modified FOLFIRINOX
    Chemotherapy

Primary outcome measures

  • 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 outcome measures (4)
  • 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]
  • 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]
  • Median OS and proportion of participants alive at 6 months. [Time frame: from baseline to week 24]
  • The proportion of participants becoming eligible for resection as determined by local multidisciplinary team review [Time frame: from baseline to week 24]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • HonorHealth Research Institute — Scottsdale
  • Stanford Cancer Center Palo Alto — Stanford
  • Beth Israel Deaconess Medical Center - Division of Hematology/Oncology — Boston
  • Henry Ford Centre — Detroit
  • Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital — Philadelphia
  • Allegheny General Hospital — Pittsburgh
  • Brown University Cancer Institute — Providence
United Kingdom · 3 centers
  • CAMBRIDGE CANCER TRIALS CENTRE-Addenbrooke's Hospital — Cambridge
  • Gary Weston Centre- Imperial College Healthcare- Du Cane Road — Hammersmith
  • The Royal Marsden- Downs Road — Sutton

Identifiers

NCT: NCT06850623 · EX-2-P2-2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗