Study on the Effectiveness of Floxuridine with Gemcitabine and Oxaliplatin for Patients with Intra-hepatic Cholangiocarcinoma Not Suitable for Surgery

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What is this study about?

This clinical trial is focused on studying a type of liver cancer known as intrahepatic cholangiocarcinoma, which is a cancer that occurs in the bile ducts inside the liver. The study is exploring treatments for patients whose cancer cannot be removed through surgery. The treatments being tested include a combination of medications: Floxuridine, Gemcitabine Hydrochloride, Oxaliplatin, Heparin, and Dexamethasone Sodium Phosphate. These medications are administered in different forms, such as injections or infusions, to see how they work together in treating this type of cancer.

The purpose of the study is to evaluate how these treatments affect the overall survival of patients. The study will involve administering these medications over a period of time and monitoring the patients’ health and response to the treatment. Some patients may receive a placebo as part of the study. The study aims to understand the effectiveness of these treatments in improving survival rates and managing the disease.

Participants in the study will receive the treatments and undergo regular health assessments to track their progress. The study will also look at various factors such as the response of the tumor to the treatment, changes in quality of life, and other health indicators. The goal is to gather information that could lead to better treatment options for patients with intrahepatic cholangiocarcinoma.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

Eligibility criteria include a confirmed diagnosis of intra-hepatic cholangiocarcinoma, disease confined to the liver, and a physical performance score of WHO/ECOG stage 0/1.

2 treatment planning

A treatment plan is developed based on individual medical conditions and study requirements.

The main objective is to evaluate overall survival using hepatic arterial infusion (HAI) with floxuridine and dexamethasone sodium phosphate or selective internal radiation therapy (SIRT) in combination with systemic gemcitabine hydrochloride and oxaliplatin.

3 medication administration

Medications are administered through specific routes: floxuridine and dexamethasone sodium phosphate via intra-arterial use, while gemcitabine hydrochloride, oxaliplatin, and heparin are given through intravenous infusion.

The frequency and dosage of each medication are determined by the treatment plan and medical team.

4 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment and manage any side effects.

This includes imaging tests such as CT scans to evaluate tumor response and blood tests to monitor health status.

5 evaluation of outcomes

The primary endpoint is the median survival time, while secondary endpoints include the proportion of patients surviving one and two years, tumor response rate, and changes in quality of life.

Additional evaluations involve changes in circulating tumor DNA (ctDNA) and tumor genomic heterogeneity.

6 completion of trial

The trial is estimated to end by December 2, 2030. Upon completion, final assessments are conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

The patient must have a condition called intra-hepatic cholangiocarcinoma, which is a type of liver cancer. This must be confirmed by a test like a biopsy, cytology, or a previous surgery.
The cancer cannot be removed by surgery right away. This means:
- The tumor cannot be completely removed without affecting important blood vessels in the liver.
- There is more than one tumor, no matter how far apart they are.
- The cancer has come back after surgery.
- The cancer has spread to nearby lymph nodes, which are small glands that help fight infection.
The cancer is only in the liver or has spread to nearby lymph nodes that can be removed.
The cancer can be seen on a scan, and at least one tumor is larger than 2 cm.
The patient must have a good physical condition, as measured by a score called WHO/ECOG stage 0/1, which means they are fully active or have some symptoms but can still do light work.
The patient must be older than 18 years.
The patient must be able to handle at least one full cycle of chemotherapy, which is a type of cancer treatment.
If the patient is eligible for a specific treatment called HAI-FUDR/DEX, they must be willing and able to travel to Oslo every two weeks.
Women who can have children must agree to use very effective birth control during the study and for a time after. Men, or men with partners who can have children, must also agree to use very effective birth control during the study and for a time after. Very effective birth control means methods that have a very low chance of failing if used correctly.

Who Cannot Join the Study?

Patients with other types of cancer besides intra-hepatic cholangiocarcinoma cannot participate. This is a type of cancer that starts in the bile ducts inside the liver.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of vulnerable populations, such as those who might not be able to give informed consent, are not eligible.
Patients who are not able to follow the study procedures or attend the required visits cannot participate.
Patients with certain medical conditions or who are taking medications that might interfere with the study treatment are not eligible.
Patients who have participated in another clinical trial recently may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Norway	Recruiting	01.12.2023

Trial locations

Investigated drugs:

HAI-FUDR/DEX is a treatment that involves delivering chemotherapy directly to the liver through the arteries. This method targets the cancer more directly, potentially reducing side effects compared to traditional chemotherapy that circulates throughout the entire body.

SIRT, or Selective Internal Radiation Therapy, is a treatment that uses tiny radioactive beads to deliver radiation directly to the liver tumors. This approach aims to shrink the tumors by targeting them with high doses of radiation while sparing the surrounding healthy tissue.

GemOx is a combination of two chemotherapy drugs, gemcitabine and oxaliplatin. This systemic treatment is used to help control the growth of cancer cells throughout the body and is often used in combination with other therapies to improve effectiveness.

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:

2023-504433-50-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Floxuridine with Gemcitabine and Oxaliplatin for Patients with Intra-hepatic Cholangiocarcinoma Not Suitable for Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?