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Study of Pemigatinib for Patients with Advanced Intrahepatic Cholangiocarcinoma with FGFR2 Changes After Local Therapy

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What is this study about?

This clinical trial is focused on studying a type of liver cancer called intrahepatic cholangiocarcinoma (iCCA), which is a cancer that occurs in the bile ducts inside the liver. Specifically, the study is looking at cases of iCCA that have certain genetic changes known as FGFR2 fusions/rearrangements. These changes can affect how the cancer grows and responds to treatment. The treatment being tested in this study is a medication called pemigatinib, which is taken in the form of tablets. Pemigatinib is designed to target and block the activity of FGFR2, which may help to slow down or stop the growth of cancer cells.

The purpose of this study is to evaluate how effective pemigatinib is when given to patients who have already undergone surgery or other local treatments to remove or destroy their cancer. The study will follow patients over a period of time to see if the cancer returns and to monitor their overall health and quality of life. Participants will take pemigatinib tablets by mouth and will have regular check-ups with the study team to assess their progress and any side effects they may experience.

Throughout the study, researchers will collect information on how long patients remain free of cancer recurrence, as well as any side effects they experience. They will also look at the overall survival of patients and how the treatment affects their quality of life. This information will help determine if pemigatinib is a beneficial treatment option for patients with this specific type of liver cancer.

1 joining the study

Upon joining the study, the patient must have a signed informed consent form. This indicates understanding and agreement to participate in the trial.

The patient must meet specific health criteria, including appropriate blood, liver, and kidney function, as well as adequate blood clotting ability.

2 initial assessment

The patient undergoes an initial assessment to confirm eligibility. This includes tests to ensure the cancer is localized and has specific genetic characteristics (FGFR2 fusions/rearrangements).

The patient must have previously received local therapy for intrahepatic cholangiocarcinoma, such as surgery or radiation, within 12 weeks prior to enrollment.

3 treatment phase

The patient begins treatment with pemigatinib, administered in the form of Pemazyre 4.5 mg tablets taken orally.

The treatment is designed to assess the effectiveness of pemigatinib in preventing cancer recurrence after local therapy.

4 monitoring and follow-up

Throughout the study, the patient attends scheduled visits for monitoring. This includes regular assessments of health status and any side effects experienced.

The primary goal is to evaluate the recurrence-free survival rate at 12 months. Secondary goals include overall survival and quality of life assessments.

5 completion of study

The study is estimated to conclude by September 30, 2025. Upon completion, the patient’s health and treatment outcomes are reviewed.

The patient may be asked to participate in additional follow-up assessments to gather long-term data on the treatment’s effectiveness and impact on quality of life.

Who Can Join the Study?

  • Sign an informed consent form, which means you agree to participate in the study after understanding all the details.
  • Have proper blood, liver, and kidney function. This includes having enough white blood cells, platelets, and hemoglobin, and normal levels of certain liver and kidney tests.
  • Have a normal level of creatinine, a waste product in the blood, or a creatinine clearance test showing your kidneys are working well.
  • Have normal blood clotting ability, unless you are on blood-thinning medication, in which case you may need to switch to a different type of medication.
  • If you have HIV, you must have a certain level of immune cells, an undetectable viral load, and be on a stable HIV treatment plan that doesn’t interfere with the study medication.
  • Be willing and able to follow the study rules, including using birth control if necessary, attending appointments, and undergoing tests.
  • If you have hepatitis B, your virus level must be low, and you must be on treatment for it and willing to continue this treatment during the study.
  • If you have hepatitis C, you can participate if you have been treated for it before the study, but not during the study.
  • Be at least 18 years old.
  • Have a specific type of liver cancer that can be treated with surgery or other local treatments, and have a certain genetic change called FGFR2 fusions or rearrangements.
  • Have received local treatment for your liver cancer within the last 12 weeks before joining the study.
  • If you are a woman who can become pregnant or a man who is sexually active with such a woman, you must use effective birth control during the study and for a short time after.
  • Have a good level of daily functioning, meaning you can carry out normal activities without much help.

Who Cannot Join the Study?

  • Patients who have already received treatment for their intrahepatic biliary tract cancer cannot participate.
  • Patients with other types of cancer that are not intrahepatic cholangiocarcinoma (iCCA) with FGFR2 fusions/rearrangements are excluded. FGFR2 fusions/rearrangements are specific changes in the genes that can affect cancer growth.
  • Patients who have serious health conditions that could interfere with the study treatment are not eligible.
  • Patients who are unable to follow the study procedures or attend the required visits cannot take part.
  • Pregnant or breastfeeding women are not allowed to participate in the study.
  • Patients who are participating in another clinical trial at the same time are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
University Hospital Jena KöR Jena Germany

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
RKH Klinken Ludwigsburg-Bietigheim gGmbH Ludwigsburg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Ulexqkcrkvfalywzjllap Adlzhhig Augsburg Germany
Udotbumunn Hdyfltew Ctxvjzv Cologne Germany
Urvstxhnhdrcjnzjqeywk Dtlexskfuqx Alm Duesseldorf Germany
Gjoiwi Uwwzdaairy Fuzslyami Frankfurt Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.10.2022

Trial locations

Investigated drugs:

Pemigatinib is a medication being studied for its effectiveness in treating patients with a specific type of liver cancer called intrahepatic cholangiocarcinoma. This cancer is known to have certain genetic changes, specifically FGFR2 fusions or rearrangements. Pemigatinib works by targeting these genetic changes, which may help to stop or slow down the growth of cancer cells. In this clinical trial, pemigatinib is given to patients who have already undergone surgery or other local treatments to remove the cancer, to see if it can help prevent the cancer from coming back.

Intrahepatic Cholangiocarcinoma – This is a type of cancer that originates in the bile ducts within the liver. It is characterized by the abnormal growth of cells in the bile ducts, which can lead to blockages and impaired liver function. The disease often progresses slowly, with symptoms such as jaundice, abdominal pain, and weight loss appearing as the cancer grows. In some cases, genetic changes like FGFR2 fusions or rearrangements can be involved in the development of this cancer. As the disease advances, it may spread to nearby tissues and organs. Early stages may not present noticeable symptoms, making it challenging to detect until it has progressed.

Trial ID:
2024-512018-16-00
Protocol code:
PEARLDIFER
NCT ID:
NCT05565794
Trial Phase:
Therapeutic exploratory (Phase II)

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