Study of Gemcitabine and Oxaliplatin Infusion for Patients with Non-Metastatic Unresectable Intra-Hepatic Cholangiocarcinoma

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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 specifically for cases where the cancer has not spread to other parts of the body and cannot be removed through surgery. The treatment being tested involves a combination of two chemotherapy drugs, gemcitabine and oxaliplatin, which are administered directly into the liver through a process called hepatic arterial infusion. This method aims to deliver the drugs more effectively to the cancerous area.

The purpose of the study is to evaluate how well this treatment works in shrinking or controlling the cancer four months after starting the treatment. Participants will receive the treatment over a period of 14 days, and their response to the treatment will be monitored using imaging techniques like MRI or CT scans. The study will also look at the safety of the treatment and its impact on the quality of life of the participants.

Throughout the study, the participants’ health will be closely monitored to assess any changes in their condition and to ensure their safety. The study aims to provide valuable information on the effectiveness of this treatment approach for patients with this specific type of liver cancer.

1 initiation of treatment

The treatment begins with the administration of two medications: gemcitabine hydrochloride and oxaliplatin.

Both medications are given through an infusion, which means they are delivered directly into the bloodstream via a vein.

The specific dosage and frequency of administration will be determined by the healthcare provider based on individual needs and response to treatment.

2 treatment cycle

The treatment is organized into cycles. Each cycle includes the administration of the medications followed by a period of rest to allow the body to recover.

The duration of each cycle and the number of cycles will be specified by the healthcare provider.

3 monitoring and evaluation

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

This includes imaging tests such as CT scans or MRIs to evaluate the size and condition of the tumor.

Blood tests are also performed to monitor overall health and organ function.

4 response assessment

The primary goal is to evaluate the objective response rate four months after starting treatment.

This assessment is based on criteria that measure the reduction in tumor size or the complete disappearance of the tumor.

5 quality of life evaluation

The impact of treatment on quality of life is assessed using a questionnaire.

This evaluation considers factors such as physical well-being, emotional health, and overall life satisfaction.

6 end of treatment

The treatment continues until the healthcare provider determines it is no longer beneficial or if significant side effects occur.

The overall duration of participation in the trial is determined by individual response and the study’s timeline.

Who Can Join the Study?

The patient must have a confirmed diagnosis of intrahepatic cholangiocarcinoma, which is a type of liver cancer, and must have been treated with first-line systemic therapy before.
The cancer must not have spread outside the liver or to the lining of the abdomen, as shown by a CT scan (a special type of X-ray).
The patient must be at least 18 years old and have a general health status of WHO PS 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed.
The patient must have a life expectancy of more than 3 months.
The disease must not be suitable for surgery aimed at curing it, as confirmed by a team of doctors including at least one experienced liver surgeon.
There must be at least one tumor that can be measured according to RECIST 1.1 criteria, which is a standard way to measure how tumors respond to treatment.
The patient must have certain blood test results:
- Platelets (a type of blood cell) must be 100,000/mm³ or more.
- Polynuclear neutrophils (another type of blood cell) must be 2,000/mm³ or more.
- Hemoglobin (a protein in red blood cells) must be 9g/dL or more, even if the patient has received a blood transfusion.
- Creatininemia (a measure of kidney function) must be less than 1.5 times the normal level.
- Creatinine clearance (another measure of kidney function) must be more than 30 mL/min.
- Bilirubinemia (a measure of liver function) must be 2 times the normal level or less, after any necessary bile duct drainage.
- ASAT and ALAT (liver enzymes) must be 5 times the normal level or less.
A hepatic MRI (a detailed scan of the liver) must be done within 30 days before starting the first cycle of treatment.
Women who can have children must use a reliable method of birth control during treatment and for at least 4 months after stopping Oxaliplatin and during treatment with Gemcitabine.
Men must use a reliable method of birth control during treatment and for at least 6 months after stopping Oxaliplatin and Gemcitabine.
The patient must provide written informed consent, which means they agree to participate in the study after being fully informed about it.
The patient must have national health insurance cover.

Who Cannot Join the Study?

Patients with metastatic cancer, which means cancer that has spread to other parts of the body, cannot participate.
Patients with resectable cancer, meaning the cancer can be removed by surgery, are not eligible.
Patients with cancer outside the liver are excluded.
Patients who are not within the specified age range for the study cannot join.
Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
Hôpital Européen Georges-Pompidou	Paris	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Hospital Edouard Herriot	Lyon	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Hopital Beaujon	Clichy	France
Cdleev Ldet Bejmac	Lyon	France
Ctqsad Hguzkmkawhh Rptfvsno Dbhwjznnvdklci	Angers	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	11.06.2018

Trial locations

Investigated drugs:

Gemcitabine is a medication used in cancer treatment. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this trial, it is administered directly into the liver’s blood supply to target the cancer more effectively.

Oxaliplatin is another cancer treatment drug that is often used in combination with other medications. It damages the DNA of cancer cells, which helps to stop their growth and spread. In this study, it is also delivered directly to the liver to treat the cancer more precisely.

Non-Metastatic Unresectable Intra-Hepatic Cholangiocarcinoma – This is a type of liver cancer that originates in the bile ducts within the liver. It is characterized by the growth of malignant cells in the intra-hepatic bile ducts, which are responsible for transporting bile from the liver to the gallbladder and small intestine. The term “non-metastatic” indicates that the cancer has not spread to other parts of the body. “Unresectable” means that the tumor cannot be surgically removed, often due to its size, location, or involvement with vital structures. As the disease progresses, it can cause symptoms such as jaundice, abdominal pain, and weight loss. The progression of the disease is typically monitored through imaging techniques like CT scans or MRIs.

Trial ID:

2024-519132-17-00

NCT ID:

NCT03364530

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Gemcitabine and Oxaliplatin Infusion for Patients with Non-Metastatic Unresectable Intra-Hepatic Cholangiocarcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?