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

Phase 2RecruitingNCT06850623

EXACT Therapeutics AS25 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Interventions

Acoustic Cluster TherapyCOMBINATION_PRODUCT

Drug: PS101; Device: Ultrasound

Modified FOLFIRINOXDRUG

Chemotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

HonorHealth Research Institute

Scottsdale, Arizona, United States

RECRUITING

Stanford Cancer Center Palo Alto

Stanford, California, United States

RECRUITING

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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