Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

PEARLDIFER - A Phase II study of pemigatinib after curative local therapy in locally advanced intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusions/rearrangements

This study, named PEARLDIFER, is testing a new tablet called Pemazyre for a type of liver cancer that starts in the bile ducts inside the liver. This specific cancer is called intrahepatic cholangiocarcinoma, and the study is for patients whose cancer has a particular genetic change (called FGFR2 fusions/rearrangements). These patients have already had surgery or other treatments to get rid of the cancer, but the study wants to see if Pemazyre can help prevent it from coming back for at least 12 months. Researchers will also look at how safe the treatment is and how it affects patients' overall quality of life, including their general health and specific symptoms.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Enrolment target

Start

19 Aug 2024

locally advanced intrahepatic cholangiocarcinoma (iCCA) with FGFR2 fusions/rearrangements

What is this study about?

This clinical trial is looking into a new treatment for a type of liver cancer called intrahepatic cholangiocarcinoma. This cancer affects the bile ducts inside the liver. The study is specifically for people whose cancer has a particular genetic feature, a change in something called FGFR2. This change can sometimes make the cancer respond differently to certain treatments.

You might be interested in this study if you've recently had surgery or other local treatments to remove your liver cancer. The main goal of the study is to see if a tablet called Pemazyre can help stop the cancer from coming back after these initial treatments. Doctors want to find out how many people remain cancer-free 12 months after starting this medication.

Beyond simply preventing recurrence, the researchers also want to understand how the treatment affects people's lives. They will be carefully monitoring any side effects to make sure the treatment is safe. They'll also be asking patients about their general health, well-being, and any symptoms they're experiencing to see if the treatment improves their quality of life.

Key takeaways

The study tests a new tablet (Pemazyre) for a specific type of liver cancer.
It's for people whose cancer has a particular genetic change (FGFR2 fusion).
Participants would have already had their cancer removed by surgery or other local treatments.
The main goal is to see if the drug can prevent the cancer from coming back for at least 12 months.
Researchers will also carefully check for side effects and how the treatment affects quality of life.
Participation involves taking tablets and regular check-ups with the study team.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old – there's no upper age limit. The study is open to both men and women.

Crucially, you would have a specific type of liver cancer called intrahepatic cholangiocarcinoma, and tests would have shown that your cancer has a particular genetic change called an FGFR2 fusion or rearrangement. You would also have already had treatment locally to remove or destroy the cancer, such as surgery.

Your doctor would need to check other medical details to make sure this study is right for you and that taking the study medication would be safe.

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?
Have you been diagnosed with intrahepatic cholangiocarcinoma (a type of liver cancer)?
Has your doctor confirmed that your cancer has an FGFR2 fusion or rearrangement?
Have you recently had surgery or another treatment to remove or destroy your liver cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be taking Pemazyre tablets. The team would monitor your health very closely with regular visits, likely involving physical examinations, blood tests, and scans. They would also ask you about any side effects you might experience and how you are feeling generally using questionnaires about your quality of life. The study aims to see how well the treatment prevents cancer recurrence over 12 months, and you would continue to be followed up after this initial period to track your overall health. The exact duration of your involvement could vary, but the main treatment phase focuses on the first year, with continued monitoring after that.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new treatment that could help prevent your cancer from returning. However, as with any medication, there are potential risks, including side effects from the Pemazyre tablets, which the study team will monitor very carefully. It's important to remember that this is a research study, and there's no guarantee the treatment will work for everyone, or that it will prevent your cancer from returning. You are free to withdraw from the study at any time, for any reason, without it 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
Germany

Common questions

What kind of cancer is this study for?

This study is for a specific type of liver cancer called intrahepatic cholangiocarcinoma, which starts in the bile ducts inside the liver, and has a particular genetic change called FGFR2 fusion.

What is Pemazyre?

Pemazyre is a tablet medication being tested in this study. It's designed to target cancers with specific genetic changes like the FGFR2 fusions found in some liver cancers.

Why is this study being done?

Doctors want to see if Pemazyre can help stop the liver cancer from coming back after patients have already had surgery or other treatments to remove it.

Will I get paid to be in this study?

Clinical trials typically do not pay participants directly, but often cover study-related costs like travel or parking. You should ask the study team about this.

What if I change my mind about participating?

You are completely free to leave the study at any time, for any reason, without it affecting your future medical care.