Study of Chemotherapy with or without FUDR/Dexamethasone for Patients with Inoperable Liver Bile Duct Cancer

2 1 1 1

What is this study about?

This clinical trial is focused on studying a type of liver cancer called intrahepatic cholangiocarcinoma, which is a cancer that occurs in the bile ducts inside the liver. The study is investigating the effectiveness of a treatment that combines two approaches: systemic chemotherapy and a method called hepatic arterial infusion (HAI). The chemotherapy drugs used in this study are GemOx, which is a combination of gemcitabine and oxaliplatin, and a combination of FUDR (a type of chemotherapy drug) and dexamethasone (a steroid) delivered directly to the liver through an infusion pump.

The purpose of the study is to compare how well patients do when they receive the combination of HAI FUDR/Dex with systemic GemOx versus when they receive only systemic GemOx. The study will involve patients who have been diagnosed with inoperable intrahepatic cholangiocarcinoma, meaning the cancer cannot be removed with surgery. Participants will be randomly assigned to one of the two treatment groups. The study will monitor the progression of the disease and assess the overall survival and response rates to the treatments.

Throughout the study, patients will receive their assigned treatments and will be closely monitored for any side effects or changes in their condition. The study aims to provide valuable information on the potential benefits and risks of adding HAI FUDR/Dex to the standard chemotherapy regimen for this type of liver cancer. The results could help improve treatment options for patients with inoperable intrahepatic cholangiocarcinoma in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, blood counts, and liver function.

A diagnosis of unresectable intrahepatic cholangiocarcinoma is required, with disease confined to the liver.

2 randomization

Participants are randomly assigned to one of two groups: one receiving systemic chemotherapy alone, and the other receiving systemic chemotherapy combined with hepatic arterial infusion (HAI) chemotherapy.

3 treatment initiation

Systemic chemotherapy involves the administration of GemOx, which is a combination of gemcitabine and oxaliplatin.

For those in the combination group, HAI chemotherapy includes FUDR (floxuridine) and dexamethasone, delivered directly to the liver through an infusion pump.

4 treatment schedule

Systemic chemotherapy is administered in cycles, typically every two weeks, with specific dosages determined by the medical team.

HAI chemotherapy is also administered in cycles, with the frequency and duration tailored to individual patient needs.

5 monitoring and assessments

Regular monitoring through blood tests and imaging studies is conducted to assess the response to treatment and any side effects.

Progression-free survival is the primary endpoint, with secondary endpoints including overall survival and response rates.

6 completion of treatment

The treatment continues until disease progression, unacceptable side effects, or completion of the study period.

Follow-up assessments are conducted to evaluate long-term outcomes and any late side effects.

Who Can Join the Study?

Must be at least 18 years old.
Must have a platelet count of at least 75,000 per microliter. Platelets are cells in your blood that help with clotting.
Creatinine level must be 1.8 mg/dL or lower. Creatinine is a waste product in your blood that comes from muscle activity.
Total bilirubin must be less than 1.5 mg/dL. Bilirubin is a substance made during the normal breakdown of red blood cells.
Hemoglobin (Hgb) must be greater than 7 g/dL. Hemoglobin is a protein in red blood cells that carries oxygen.
ECOG performance status must be 0 or 1. This is a scale used to assess how a patient’s disease is progressing and how the disease affects their daily living abilities.
Must have a confirmed diagnosis of intrahepatic cholangiocarcinoma, which is a type of liver cancer.
Must have evidence of cancer that has spread only to the liver, with certain lymph node involvement allowed if they can be surgically removed.
Must have disease that can be measured using imaging techniques, with a minimum lesion size of 2 cm.
The disease must be considered unresectable, meaning it cannot be removed with surgery.
Must be a candidate for general anesthesia and certain surgical procedures involving the liver.
Patients with chronic hepatitis or cirrhosis can participate if they are classified as Child-Pugh class A, which is a scoring system to assess the severity of liver disease.
Must have a white blood cell (WBC) count of at least 2,000 per microliter and an absolute neutrophil count (ANC) of at least 1,000 per microliter. These are measures of immune cells in your blood.

Who Cannot Join the Study?

Patients with other types of cancer that are not the specific type being studied.
Patients who have had previous treatments that might interfere with the study results.
Patients with severe health conditions that could make participation unsafe.
Patients who are unable to follow the study procedures or attend required visits.
Patients who are pregnant or breastfeeding, as the study treatments might affect the baby.
Patients who are participating in another clinical trial at the same time.
Patients with allergies to the study medications or their ingredients.
Patients with certain infections that could be worsened by the study treatments.
Patients with a history of substance abuse that could affect their ability to participate.
Patients who have had a recent major surgery that could impact their health during the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Evxbipd Uxsiwymyutly Miheqcf Cjxwvtv Rwfduswaz (drkkppm Mic	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	19.12.2022

Trial locations

GemOx is a combination of two chemotherapy drugs, gemcitabine and oxaliplatin. This treatment is used to stop the growth of cancer cells by interfering with their DNA and preventing them from dividing. In this trial, GemOx is used as a systemic therapy, meaning it is administered to affect the entire body, to treat patients with intrahepatic cholangiocarcinoma, a type of liver cancer.

HAI FUDR/Dexamethasone involves the use of a chemotherapy drug called floxuridine (FUDR) delivered directly to the liver through a hepatic artery infusion (HAI). This method targets the liver more directly, potentially increasing the effectiveness of the treatment in that area. Dexamethasone is a steroid that is often used to reduce inflammation and manage side effects associated with chemotherapy. In this trial, HAI FUDR/Dexamethasone is combined with systemic GemOx to evaluate if it improves the progression-free survival of patients compared to using GemOx alone.

Unresectable Intrahepatic Cholangiocarcinoma – This is a type of liver cancer that originates in the bile ducts within the liver. It is termed “unresectable” because it cannot be removed completely through surgery. The disease progresses as cancer cells grow and spread within the liver and potentially to other parts of the body. Symptoms may include jaundice, abdominal pain, and weight loss as the disease advances. The progression of the disease can vary, with some individuals experiencing a slow growth of cancer cells, while others may have a more rapid progression. The condition is often diagnosed at an advanced stage due to the lack of early symptoms.

Trial ID:

2024-518065-10-00

Protocol code:

20-348

NCT ID:

NCT04891289

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of Chemotherapy with or without FUDR/Dexamethasone for Patients with Inoperable Liver Bile Duct Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?