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Study on the Effectiveness of Yttrium-90 Microspheres and Capecitabine for Patients with Operable Intrahepatic 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 cancer known as intrahepatic cholangiocarcinoma, which is a cancer that occurs in the bile ducts inside the liver. The study is exploring the effectiveness of a treatment combination that includes Selective Internal Radiation Therapy (SIRT) using Yttrium-90 glass microspheres and a medication called Capecitabine. Capecitabine is taken in the form of film-coated tablets and is commonly used in cancer treatment.

The purpose of this study is to evaluate how well this combination works in patients who have operable intrahepatic cholangiocarcinoma, meaning the cancer can be surgically removed. Participants in the study will receive the combination treatment before surgery, which is known as a neoadjuvant setting. The study will follow participants over a period to observe the effects of the treatment, including how well the cancer responds and the success of the surgery in removing the cancer.

Throughout the study, researchers will monitor various outcomes, such as the number of patients who have successful surgeries with adequate margins, which means the cancer is removed with a safe amount of surrounding tissue. They will also look at the overall survival rates and the percentage of cancer tissue that is destroyed by the treatment. This study aims to provide valuable information on the potential benefits of combining SIRT with Capecitabine for treating this type of 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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, performance status, and tumor characteristics.

    Informed consent is required, ensuring understanding of the study's purpose and procedures.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to gather baseline health information and confirm the diagnosis of intrahepatic cholangiocarcinoma, a type of biliary tract cancer.

  3. Step 3

    Treatment phase

    The treatment involves a combination of Selective Internal Radiation Therapy (SIRT) and capecitabine.

    Capecitabine is administered orally in the form of 500 mg film-coated tablets. The dosage and frequency are determined by the study protocol and medical team.

  4. Step 4

    Monitoring and follow-up

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

    Follow-up appointments are scheduled to evaluate surgical outcomes and overall health status.

  5. Step 5

    Surgical evaluation

    The effectiveness of the treatment is evaluated based on surgical margins and the extent of tumor resection.

    The primary goal is to achieve adequate surgical margins and assess the response of the tumor to the treatment.

  6. Step 6

    Long-term follow-up

    Long-term follow-up is conducted to monitor disease-free survival and overall survival.

    The study aims to gather data on the effectiveness of the treatment combination over time.

Who can join the trial?

8 criteria

  • Must be over 18 years old.
  • Must have an ECOG Performance Status of less than 2. This is a scale used to assess how well a person can perform daily activities.
  • Must have a confirmed diagnosis of ICC, which stands for intrahepatic cholangiocarcinoma, a type of bile duct cancer.
  • Must not have received any previous treatment for ICC.
  • The tumor must be considered removable by a liver and bile duct surgeon, and this must be confirmed by a group of surgical experts.
  • There must be a significant risk of close margins, which means: the surgeon predicts the space between the tumor and the edge of the removed tissue is less than 1 cm, or the tumor is larger than 5 cm, or there are multiple tumors that can be removed, confirmed by a group of surgical experts.
  • Must be registered with a social security scheme.
  • Must have received information about the study and signed a consent form, or a legal representative must have done so.

Who cannot join the trial?

1 criterion

  • There are no specific reasons listed that would prevent a patient from participating in this study.
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Investigated drugs

  • Selective Internal Radiation Therapy (Yttrium-90 glass microspheres)

    is a treatment that involves delivering radiation directly to a tumor in the liver. Tiny glass beads containing a radioactive substance called Yttrium-90 are injected into the blood vessels that supply the tumor. This allows for high doses of radiation to be delivered directly to the cancer cells while minimizing exposure to the surrounding healthy tissue.

  • Capecitabine

    is a type of chemotherapy medication that is taken orally in the form of a pill. It works by interfering with the growth of cancer cells, slowing down or stopping their ability to multiply. In this trial, Capecitabine is used in combination with Selective Internal Radiation Therapy to enhance the treatment's effectiveness against cholangiocarcinoma, a type of liver cancer.

What is already known about the treatment

Capecitabine – Capecitabine is an oral medication used in the treatment of certain types of cancer, including biliary tract cancer. It is currently being studied in clinical trials to evaluate its effectiveness when combined with other treatments, such as Selective Internal Radiation Therapy (SIRT), for operable intrahepatic cholangiocarcinoma. Capecitabine works by interfering with the growth of cancer cells, slowing or stopping their spread in the body. It belongs to a class of drugs known as antimetabolites, which mimic the building blocks of DNA, disrupting the cancer cells' ability to reproduce.

Investigated diseases

Biliary Tract Cancer – This is a type of cancer that occurs in the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and small intestine. It can develop in any part of the bile duct system and is often categorized based on its location, such as intrahepatic, perihilar, or distal. The disease typically progresses slowly, and symptoms may not appear until the cancer is advanced. Common symptoms include jaundice, abdominal pain, and weight loss. As the cancer grows, it can block the bile ducts, leading to further complications. The progression of the disease can vary, with some cases remaining localized while others may spread to nearby organs or lymph nodes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516683-29-00Protocol code2017-02-32-005Estimated enrolment62 patientsSponsorCentre De Lutte Contre Le Cancer Eugene Marquis

sourced from the EU Clinical Trials Register and site verification

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