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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

18 criteria

  • 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 trial?

5 criteria

  • 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.
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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.

What is already known about the treatment

  • Gemcitabine

    This medication is administered through hepatic arterial infusion, a method where the drug is delivered directly into the liver's blood supply. It is currently being studied in clinical trials for its effectiveness in treating non-metastatic unresectable intra-hepatic cholangiocarcinoma, a type of liver cancer. Gemcitabine is primarily used for its ability to interfere with the growth of cancer cells by incorporating itself into the DNA during cell division, thereby inhibiting further replication. It is classified as an antimetabolite, a type of chemotherapy drug.

  • Oxaliplatin

    This medication is also administered via hepatic arterial infusion, targeting the liver directly. It is under investigation in clinical trials for its role in treating non-metastatic unresectable intra-hepatic cholangiocarcinoma. Oxaliplatin works by forming cross-links in DNA, which prevents cancer cells from dividing and growing. It belongs to the class of drugs known as platinum-based chemotherapy agents.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519132-17-00Estimated enrolment40 patientsSponsorCentre Hospitalier Universitaire De Montpellier

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).