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RecruitingPHASE2INTERVENTIONAL

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

This study is for people in the UK with locally advanced pancreatic cancer that can't be removed by surgery. It's looking at a new treatment called Acoustic Cluster Therapy (ACT) when given alongside a common chemotherapy treatment called modified FOLFIRINOX. Researchers want to find out if this combination is safe and if it works better than chemotherapy alone to shrink the cancer. ACT involves using a special drug (PS101) and ultrasound directly applied to the tumour. Patients will receive ACT on the first day of each chemotherapy cycle. Doctors will closely monitor patients' health, any side effects, and how well the treatment is working through scans. This is a Phase 2 study, meaning it's an important step in understanding this potential new treatment.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
EXACT Therapeutics AS
Enrolment target
25
Start
19 Jun 2025
Estimated completion
15 Jul 2027

What is this study about?

This research study is about finding new and better ways to treat locally advanced pancreatic cancer. This is a type of pancreatic cancer that has grown outside the pancreas but hasn't spread to distant parts of the body, and it usually can't be removed with surgery right away.

The study is investigating a new treatment called Acoustic Cluster Therapy (ACT). This treatment involves giving a special medicine (PS101) directly to the patient and then using ultrasound waves, which are like sound waves, to target the cancer. The idea is that this combination might help the chemotherapy medicine work better on the tumour. ACT is being given at the same time as a standard chemotherapy treatment called modified FOLFIRINOX, which is often used for this type of cancer.

The main goal of the study is to see if adding ACT to chemotherapy is safe for patients and if it can help shrink the cancer more effectively than chemotherapy on its own. By carefully checking patients' well-being and monitoring the cancer's response with regular scans, the research team hopes to learn more about this promising new approach.

Key takeaways

  • This study is for locally advanced pancreatic cancer not suitable for immediate surgery.
  • It combines a new treatment (ACT) with standard chemotherapy.
  • The aim is to see if ACT makes chemotherapy more effective and is safe.
  • You'll get regular health checks and scans to monitor your progress.
  • You can stop participating in the study at any time.

Who may be eligible?

This study is specifically for adults aged 18 or older who have been diagnosed with locally advanced pancreatic cancer. This means your cancer has grown locally but hasn't spread widely, and doctors have decided that surgery to remove it isn't the best option for you at this time. You also need to be well enough to safely receive the specific chemotherapy treatment called modified FOLFIRINOX, as your doctor will assess.

You cannot take part in this study if you've already had any treatment for your pancreatic cancer – this includes previous chemotherapy, surgery, or radiation therapy. However, if you've had procedures like a shunt to bypass a blockage or a stent fitted for a bile duct problem, you might still be able to join. The important thing is that the cancer itself hasn't been treated before.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I have been diagnosed with locally advanced pancreatic cancer.
  2. My doctors have said my cancer cannot be removed by surgery at this time.
  3. I have not had any previous treatments for my pancreatic cancer (like chemotherapy or radiation).
  4. My doctor thinks I am well enough to receive modified FOLFIRINOX chemotherapy.
  5. I am 18 years old or older.
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive Acoustic Cluster Therapy (ACT) along with modified FOLFIRINOX chemotherapy. The ACT treatment (which involves the PS101 medicine and ultrasound) will be given on the first day of each chemotherapy cycle. Each cycle of chemotherapy lasts for two weeks, and you could have up to eight of these cycles.

Throughout the study, the medical team will regularly check on your health and well-being, including any side effects you might experience. These checks will happen during your chemotherapy visits. To see how well the treatment is working on your cancer, you will have CT scans every eight weeks. The total duration of your active treatment would depend on how many cycles your doctor determines are appropriate for you, up to the maximum of eight two-week cycles, plus follow-up scans.

Potential risks and benefits

Taking part in a clinical trial means you'll receive careful monitoring and potentially benefit from a new treatment not yet widely available. While Acoustic Cluster Therapy (ACT) is being investigated as a way to make chemotherapy more effective, there's no guarantee it will work for everyone, and it might not improve your condition. Like all medical treatments, there's a possibility of side effects from both ACT and chemotherapy, and these will be carefully monitored by your care team. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (10)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • HonorHealth Research Institute
    Verified postcode
    Scottsdale, United States· Recruiting
  • Stanford Cancer Center Palo Alto
    Verified postcode
    Stanford, United States· Recruiting
  • Beth Israel Deaconess Medical Center - Division of Hematology/Oncology
    Verified postcode
    Boston, United States· Recruiting
  • Henry Ford Centre
    Verified postcode
    Detroit, United States· Recruiting
  • Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital
    Verified postcode
    Philadelphia, United States· Recruiting
  • Allegheny General Hospital
    Verified postcode
    Pittsburgh, United States· Recruiting
  • Brown University Cancer Institute
    Verified postcode
    Providence, United States· Recruiting
  • CAMBRIDGE CANCER TRIALS CENTRE-Addenbrooke's Hospital
    Verified postcode
    Cambridge, United Kingdom· Recruiting
  • Gary Weston Centre- Imperial College Healthcare- Du Cane Road
    Verified postcode
    Hammersmith, United Kingdom· Recruiting
  • The Royal Marsden- Downs Road
    Verified postcode
    Sutton, United Kingdom· Recruiting

Common questions

What is Acoustic Cluster Therapy (ACT)?

ACT is a new treatment being tested that uses a special medicine and ultrasound waves aimed at the cancer to try and make chemotherapy work better.

What is 'modified FOLFIRINOX'?

Modified FOLFIRINOX is a standard combination of chemotherapy medicines often used to treat pancreatic cancer.

Will I still receive my usual care if I join?

Yes, you will continue to receive good medical care, and your doctors will closely monitor your health throughout the study.

How long does the treatment phase of the study last?

You could receive up to eight cycles of treatment, with each cycle lasting two weeks.

Can I leave the study if I change my mind?

Yes, you can decide to stop participating in the study at any time, for any reason, and it won't affect your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Acoustic Cluster Therapy (ACT) With Chemotherapy for the Tre…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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