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NCT06850623 | RECRUITING | Locally Advanced Pancreatic Adenocarcinoma

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

EXACT Therapeutics AS

Brief Summary:

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.

Condition or disease

Locally Advanced Pancreatic Adenocarcinoma

Intervention/treatment

Acoustic Cluster Therapy

Modified FOLFIRINOX

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 25 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-06-19
Estimated Primary Completion Date : 2026-12-15
Estimated Study Completion Date : 2027-07-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer

Location Details

NCT06850623

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

HonorHealth Research Institute

Scottsdale, arizona, United States, 85258

RECRUITING

United States, road cancer

Henry Ford Centre

Detroit, road cancer, United States, 48202

RECRUITING

United States, Pennsylvania

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States, 15212

RECRUITING

United States, Rhode Island

Brown University Cancer Institute

Providence, Rhode Island, United States, 02906