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

EXACT Therapeutics

Status and phase

Enrolling

Phase 2

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Treatments

Drug: Modified FOLFIRINOX

Combination Product: Acoustic Cluster Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT06850623

EX-2-P2-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.