AuthorisedTherapeutic confirmatory (Phase III)Interventional

The impact of Thromboprophylaxis on Progression Free Survival of Patients with Advanced Pancreatic Cancer. The Pancreatic Cancer & Tinzaparin Prospective (imPaCT-PRO) study

This important study, called imPaCT-PRO, is investigating if a blood-thinning medicine, innohep®, can improve outcomes for people with advanced pancreatic cancer. Specifically, researchers want to see if patients taking innohep® live longer without their cancer progressing, compared to those not taking it. They will also carefully track how many patients in each group develop blood clots, such as deep vein thrombosis (DVT) or pulmonary embolism (PE), as pancreatic cancer can increase the risk of these. The study will also look at side effects, like bleeding, and how the medicine affects a person's quality of life. This is a Phase 3 trial, meaning it's a large study to confirm the treatment’s effects.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Institute Of Molecular Medicine And Biomedical Research

Enrolment target

450

Start

23 Jan 2025

Thromboprophylaxis in patients with advanced pancreatic cancer

What is this study about?

When someone has advanced pancreatic cancer, the body can sometimes be more likely to form blood clots. These clots can be very serious if they block blood flow, for example, to the lungs.

This study is looking at a medicine called innohep®. This medicine is a type of blood thinner, also known as an anticoagulant. The main goal is to find out if giving innohep® to people with advanced pancreatic cancer can help them live longer without their cancer getting worse. It will also see if it reduces the number of serious blood clots.

Researchers will compare two groups of patients: one group will receive innohep®, and the other will not. By carefully observing both groups, they hope to understand if innohep® is a safe and helpful addition to the care of people with advanced pancreatic cancer. They'll also check for any side effects, like bleeding, and see how the treatment affects how people feel day-to-day.

Key takeaways

This study is for people with advanced pancreatic cancer.
It tests if a blood-thinning medicine called innohep® helps improve outcomes.
Primary goals are to see if cancer progression is slowed and blood clots are prevented.
It's a large, important stage 3 trial.
Participation involves regular clinic visits and close monitoring.

Who may be eligible?

This study is open to both men and women. To take part, you need to be at least 18 years old. There's no upper age limit, so older adults can also consider joining.

More specific details about your health and your pancreatic cancer would be discussed with the study team. They will check if your current health status and medical history meet all the study's requirements.

It's important that you discuss this with your specialist doctor, who knows your full medical history, to see if this study would be a good fit for you.

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 old or older?
Do you have advanced pancreatic cancer?
Are you able to attend regular hospital or clinic appointments?
Are you happy to be randomly assigned to a treatment group (with or without innohep®)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have regular visits to your clinic or hospital for check-ups and to receive the study medication (innohep®). This medication is given as an injection.

During your time in the study, doctors and nurses would perform regular assessments, which might include blood tests, scans, and questionnaires about how you are feeling and your quality of life. They will closely monitor you for any changes in your health, any side effects, or any signs of blood clots or bleeding.

They would follow your progress for many months, possibly up to 10 months or longer, to see how the treatment affects your cancer and overall health. The specific number of visits and tests will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that might be beneficial, and you'll receive very close medical care and monitoring. However, there are potential risks, most notably the risk of bleeding from the blood-thinning medicine. There could also be other side effects, and there's no guarantee the treatment will work for you. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Greece

Common questions

What is advanced pancreatic cancer?

This means the pancreatic cancer has grown beyond the pancreas and may have spread to other parts of the body.

What are blood clots and why are they a concern?

Blood clots are clumps of blood that can form in veins. If they form in the legs (DVT) or travel to the lungs (PE), they can be very serious. People with pancreatic cancer have a higher risk of developing them.

What is innohep®?

Innohep® is a medicine that makes your blood thinner and less likely to clot. It's often used to prevent and treat blood clots.

What does 'PFS' mean?

PFS stands for 'Progression-Free Survival'. It's the length of time a person lives without their cancer getting worse or spreading.

Will I definitely get the medicine if I join the study?

This study compares a group receiving innohep® with a group not receiving it. You and your doctor won't choose which group you're in; this is decided randomly, like flipping a coin. This ensures a fair comparison.