Locally Advanced Pancreatic Adenocarcinoma
Conditions
Keywords
pancreatic cancer, PS101, ultrasound, microbubbles, Pancreatic Ductal Carcinoma, locally advanced pancreatic cancer, first line treatment, chemotherapy, Acoustic Cluster Therapy, mFOLFIRINOX
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.
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_PRODUCTAcoustic Cluster Therapy
Drug: PS101; Device: Ultrasound
Chemotherapy
Sponsors
EXACT Therapeutics AS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | From baseline to end of treatment (up to Week 24) |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 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. | From baseline up to week 24 |
| Median OS and proportion of participants alive at 6 months. | from baseline to week 24 |
| The proportion of participants becoming eligible for resection as determined by local multidisciplinary team review | from baseline to week 24 |
Countries
United Kingdom, United States
Outcome results
None listed