Study on Preventing Liver Recurrence in Patients with Intrahepatic Cholangiocarcinoma Using Floxuridine via Hepatic Arterial Infusion Pump

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What is this study about?

This clinical trial is focused on studying intrahepatic cholangiocarcinoma, a type of liver cancer. The treatment being tested is called hepatic arterial infusion pump chemotherapy (HAIP), which involves delivering chemotherapy directly to the liver through a pump. The specific drug used in this treatment is Floxuridin, a derivative of 5-FU, which is commonly used in cancer treatment. The purpose of the study is to evaluate how effective this treatment is in preventing the cancer from coming back in the liver after surgery.

Participants in the study will undergo a surgical procedure called a partial hepatectomy, where part of the liver is removed. After the surgery, they will receive the HAIP chemotherapy to help prevent the cancer from returning. The study will monitor participants over a period of time to see if the treatment helps in keeping the cancer from coming back. The study will also look at other factors such as overall survival, quality of life, and any side effects from the chemotherapy.

The trial aims to provide valuable information on whether this approach can improve outcomes for patients with intrahepatic cholangiocarcinoma. By focusing on the recurrence of cancer in the liver, the study hopes to find a way to enhance the effectiveness of current treatments and improve the quality of life for those affected by this disease.

1 surgery preparation

The trial begins with preparation for surgery. The patient must have a diagnosis of resectable intrahepatic cholangiocarcinoma (iCCA) based on imaging. No tissue sample confirmation is needed before surgery.

A CT scan with early arterial phase is performed to ensure that a catheter can be placed for hepatic arterial infusion pump (HAIP) chemotherapy. The default site for catheter insertion is the gastroduodenal artery (GDA).

2 surgery

The patient undergoes a partial hepatectomy, which is a surgical procedure to remove part of the liver affected by iCCA.

During the surgery, a catheter is positioned for HAIP chemotherapy. This is done to allow for the administration of chemotherapy directly to the liver.

3 post-surgery recovery

After surgery, the patient enters a recovery phase. This period is crucial for healing and monitoring for any immediate postoperative complications.

The patient’s overall health and recovery progress are closely observed.

4 adjuvant chemotherapy

Once the patient has sufficiently recovered from surgery, adjuvant HAIP chemotherapy begins. This involves administering chemotherapy directly into the liver through the previously placed catheter.

The specific medication, dosage, and frequency are determined by the medical team based on individual patient needs and trial protocols.

5 follow-up and monitoring

The patient is regularly monitored for any signs of liver recurrence and overall health status. This includes checking for chemotherapy-related side effects and assessing quality of life.

The primary goal is to achieve a two-year hepatic recurrence-free survival. Secondary goals include overall recurrence-free survival, overall survival, and evaluation of any adverse events.

Who Can Join the Study?

Must be 18 years or older.
Have an ECOG performance status of 0 or 1. This is a scale that measures how well a person can perform daily activities. A score of 0 means fully active, and 1 means some restrictions but can still do light work.
Have a diagnosis of resectable intrahepatic cholangiocarcinoma (iCCA) based on imaging tests. This means the cancer can be surgically removed, and no tissue sample confirmation is needed before surgery.
Must be able to undergo a laparotomy, which is a surgical procedure involving a large incision in the abdomen.
It must be technically possible to place a catheter for HAIP chemotherapy based on a specific type of CT scan. The catheter is usually inserted at a site called the GDA, and having unusual liver arteries is not a problem for this procedure.
Must have adequate bone marrow, liver, and kidney function as shown by lab tests done within 30 days before joining the study. These tests include:
- Absolute neutrophil count (ANC) of at least 1.5 x 10⁹/L. This measures a type of white blood cell important for fighting infections.
- White blood cell count (WBC) of at least 2.5 x 10⁹/L. This measures the total number of white blood cells.
- Platelets of at least 100 x 10⁹/L. Platelets help with blood clotting.
- Glomerular filtration rate (GFR) of at least 30 ml/min. This measures how well the kidneys are working.
- Haemoglobin (Hb) of at least 5.5 mmol/L. This measures the amount of oxygen-carrying protein in the blood.
- Total bilirubin of 25 µmol/L or less. This measures a substance made by the liver, and high levels can indicate liver problems.
Must provide written informed consent. This means agreeing to participate in the study after being fully informed about it, following international and local guidelines.

Who Cannot Join the Study?

Patients with other types of cancer besides intrahepatic cholangiocarcinoma (iCCA) cannot participate. This is a type of cancer that starts in the bile ducts inside the liver.
Patients who are not in the age range specified for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to undergo surgery to remove the cancer cannot participate. The study is for those who can have the cancer surgically removed.
Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent situation, cannot participate.
Patients who are not able to receive the specific type of chemotherapy being tested in the study cannot participate. This chemotherapy is given directly to the liver.
Patients who have other serious health conditions that could interfere with the study treatment cannot participate.
Patients who are pregnant or breastfeeding cannot participate, as the treatment may affect the baby.
Patients who are participating in another clinical trial cannot participate, as this could affect the results of the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Aghmwgrdw Uuf	Amsterdam	The Netherlands
Eiwjmdu Uthrnqxthfod Mmdceit Cgrrxtv Rccvuwpqo (xyswncy Mza	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.06.2024

Trial locations

Hepatic Arterial Infusion Pump Chemotherapy (HAIP) is a treatment method used in this trial. It involves delivering chemotherapy directly to the liver through a pump. This approach aims to target liver cancer cells more effectively by concentrating the medication in the liver, potentially reducing the risk of cancer returning after surgery. The trial is investigating how well this method works for patients who have had surgery to remove intrahepatic cholangiocarcinoma, a type of liver cancer.

Investigated diseases:

Cholangiocarcinoma

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. As the disease progresses, it may cause symptoms such as jaundice, abdominal pain, and weight loss. The cancer can spread to nearby tissues and organs, complicating the condition. It is often diagnosed at an advanced stage due to the subtlety of early symptoms. The progression of the disease can vary, with some cases advancing more rapidly than others.

Trial ID:

2024-513726-33-00

Protocol code:

PUMP IV

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Preventing Liver Recurrence in Patients with Intrahepatic Cholangiocarcinoma Using Floxuridine via Hepatic Arterial Infusion Pump

What is this study about?

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