RecruitingPHASE1INTERVENTIONAL

CHemotherapy and Stool Transplant in PDAC (CHASe-PDAC)

This research study, called CHASe-PDAC, is investigating a new approach for advanced pancreatic cancer that has spread or can't be removed by surgery. It combines a 'stool transplant' (Fecal Microbiota Transplantation) with standard chemotherapy drugs, gemcitabine and nab-paclitaxel. The main aim is to check if this combination is safe for patients. Researchers will also look at how patients respond to the treatment, studying things like gut bacteria and immune system changes, as well as general well-being. This is an early-stage study involving 20 patients and will take place in London, Ontario, Canada, at the Verspeeten Family Cancer Centre. It's a stepping stone to potentially finding more effective ways to help people with this type of cancer.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

John Lenehan

Enrolment target

Start

08 Jan 2025

Estimated completion

01 Feb 2028

Unresectable or Metastatic Advanced Pancreatic Ductal Adenocarcinoma

What is this study about?

Pancreatic cancer can be very challenging to treat, especially when it has spread to other parts of the body or can't be removed by surgery. Doctors are always looking for new and better ways to help patients.

This study, called CHASe-PDAC, is exploring a new idea. It combines the usual chemotherapy drugs, gemcitabine and nab-paclitaxel, with something called a 'stool transplant' (scientifically known as Fecal Microbiota Transplantation or FMT). A stool transplant involves taking healthy gut bacteria from a donor and giving it to another person. The idea is that these healthy bacteria might help improve how the body responds to treatment or reduce side effects. This study is an early phase (Phase 1), which means the main goal is to carefully check if this new combination treatment is safe for patients.

The researchers will give this combined treatment to a small group of 20 patients. Besides looking at safety, they will also closely monitor how patients' cancer responds, study the gut bacteria, and check the body's immune system. They'll also ask patients about their experience to understand how the treatment affects their daily life. The findings from this study will help doctors decide if this new approach is promising enough to investigate further in larger studies, with the ultimate goal of improving treatments for pancreatic cancer.

Key takeaways

This is an early-stage study testing a new combination treatment for advanced pancreatic cancer.
It combines standard chemotherapy with a 'stool transplant' (FMT) to see if it's safe and how it works.
The main goal is to check safety and look for early signs of how effective it might be.
Participation involves receiving chemotherapy, FMT capsules, and regular check-ups.
The study is for patients whose pancreatic cancer has spread or can't be removed by surgery.
Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to be 18 years or older and have a confirmed diagnosis of pancreatic cancer that has either spread or cannot be removed through surgery. You should also be fairly active and able to carry out most daily tasks without much trouble.

You would already be planned to receive the standard chemotherapy drugs gemcitabine and nab-paclitaxel, and you must be able to swallow capsules. It's important to understand that while researchers hope to learn more, the long-term safety of stool transplants isn't fully known yet. You also need to have measurable cancer, meaning doctors can track its size.

However, you can't join if you've had chemotherapy for pancreatic cancer before. You also can't be pregnant, breastfeeding, or planning to have children. People with certain immune system problems (like HIV) or those who have recently taken antibiotics are also not able to take part. If you've been taking probiotic supplements, you'd need to stop them for at least 3 days before the stool transplant.

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.

Are you 18 years or older?
Do you have pancreatic cancer that is advanced (cannot be removed or has spread)?
Are you planning to start gemcitabine and nab-paclitaxel chemotherapy as your first treatment?
Can you swallow capsules?
Have you not had chemotherapy for pancreatic cancer before?
Are you not pregnant or breastfeeding, and not planning to conceive?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the standard chemotherapy drugs (gemcitabine and nab-paclitaxel) as planned by your cancer doctor. In addition to this, you will also receive the 'stool transplant' through capsules that you swallow. This will happen during your first-line treatment for pancreatic cancer. The study will involve regular visits to the Verspeeten Family Cancer Centre in London, Ontario, where you will have check-ups, blood tests, and scans to monitor your health and how the treatment is working. Researchers will also collect samples (like stool samples) to study your gut bacteria and immune system. You will also be asked about your health and how you are feeling throughout the study. The total duration of your participation will depend on how you respond to treatment, but the safety part of the study is a key focus early on.

Potential risks and benefits

Like all treatments and studies, there are potential benefits and risks. The potential benefit is that this new combination treatment might be more effective than standard chemotherapy alone, or it might help manage side effects, though this is not guaranteed as it's an early-stage study. Possible risks related to the stool transplant include side effects like tummy discomfort or, rarely, infections, though the donor stool is carefully screened. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Verspeeten Family Cancer Centre (formerly known as the London Regional Cancer Program) London Health Sciences Centre
Verified postcode
London, Canada· Recruiting

Common questions

What is a 'stool transplant'?

A 'stool transplant', or Fecal Microbiota Transplantation (FMT), involves taking healthy bacteria from the gut of a screened donor and giving them to another person. The aim is to introduce beneficial bacteria into your gut.

Why are doctors looking at stool transplants for pancreatic cancer?

There's growing interest in how the bacteria in our gut might affect the immune system and how well cancer treatments work. Researchers want to see if changing the gut bacteria could make chemotherapy more effective or safer for pancreatic cancer patients.

Will I stop my regular chemotherapy if I join this study?

No, this study combines the stool transplant with your planned standard chemotherapy (gemcitabine and nab-paclitaxel). It's an add-on, not a replacement for your current treatment.

How will I receive the stool transplant?

You will receive the stool transplant in the form of capsules that you swallow. This is a simple and non-invasive way to deliver the healthy donor bacteria.

Where does this study take place?

This study is being conducted at the Verspeeten Family Cancer Centre in London, Ontario, Canada.

How to find out more

John G Lenehan, MD

john.lenehan@lhsc.on.ca 519-685-8640 Official trial record

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