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Study of Radioembolization Combined with Cisplatin, Gemcitabine and Durvalumab Treatment in Patients with Unresectable Liver Cholangiocarcinoma

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on patients with intrahepatic cholangiocarcinoma, a type of bile duct cancer that occurs in the liver and cannot be surgically removed. The treatment approach combines three different medications: durvalumab (an immunotherapy drug that helps the immune system fight cancer cells), cisplatin and gemcitabine (chemotherapy medications), along with a procedure called radioembolization, which delivers radiation directly to liver tumors through blood vessels.

The purpose of this research is to determine how well this combination treatment works and how safe it is for patients with liver-predominant intrahepatic cholangiocarcinoma. The study will evaluate whether tumors respond to the treatment and monitor any side effects that may occur during the therapy.

The treatment plan involves first performing radioembolization, followed by a combination of the three medications given through intravenous infusion. The medications will be administered over a period of six months. Throughout the study, patients will undergo regular medical examinations and imaging tests to monitor their response to treatment and any potential side effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation and preparation

    Before starting treatment, your liver function will be assessed using specialized imaging tests

    The medical team will perform blood tests to check your hemoglobin, platelet count, and other important health indicators

    Your kidney and liver function will be evaluated through specific blood tests

  2. Step 2

    First treatment phase - Radioembolization

    Radioembolization (TARE) will be performed - this is a procedure where tiny radioactive particles are delivered directly to liver tumors through blood vessels

    The procedure requires preparation with angiography and scintigraphy to ensure safe delivery

  3. Step 3

    Combined medication treatment

    Following radioembolization, you will receive a combination of three medications:

    Cisplatin - given through intravenous infusion

    Gemcitabine - given through intravenous infusion

    Durvalumab - given through intravenous infusion

  4. Step 4

    Monitoring and evaluation

    Regular imaging scans will be performed to monitor your response to treatment

    Blood samples will be taken at scheduled intervals

    Your overall health status will be monitored through regular medical examinations

    The main evaluation of treatment effectiveness will occur at 3 months and 6 months

  5. Step 5

    Follow-up period

    The study continues with regular monitoring until November 2025

    Regular assessments will track your progress and any side effects

    Additional imaging scans and blood tests will be performed according to the study schedule

Who can join the trial?

15 criteria

  • Age between 18 and 80 years
  • Body weight more than 30 kg
  • Must have liver cancer known as intrahepatic cholangiocarcinoma that cannot be removed by surgery
  • No previous cancer treatments or participation in other clinical trials
  • Good physical condition with an ECOG score of 0 or 1 (able to perform daily activities with minimal assistance)
  • Life expectancy of at least 12 weeks
  • Normal heart and lung function
  • Good liver function, classified as Child-Pugh Class A (a scoring system that assesses liver function)
  • Adequate blood test results: - Hemoglobin level at least 9 g/dL - Platelet count at least 75,000/mm³ - Adequate white blood cell count
  • Normal kidney function as shown by blood tests
  • Liver function tests within acceptable ranges
  • Negative tests for hepatitis B and C
  • Must be able to understand and sign informed consent documents
  • Must be willing to attend all scheduled appointments and follow study requirements
  • Must be suitable for a procedure called radioembolization (confirmed by special imaging tests)

Who cannot join the trial?

14 criteria

  • Prior treatment with immunotherapy (medications that help your immune system fight cancer)
  • Active or prior autoimmune disease (condition where your immune system attacks healthy cells) within the past 2 years
  • Brain metastases (cancer that has spread to the brain) that are not treated and stable
  • History of organ transplant
  • Current or recent use of immunosuppressive medications (drugs that weaken your immune system)
  • Active hepatitis B or C infection (viral infections affecting the liver)
  • Active tuberculosis (infectious lung disease)
  • Pregnant or breastfeeding women
  • Serious heart conditions or uncontrolled high blood pressure
  • Other active cancers requiring treatment (except for certain skin cancers)
  • Known allergies to study medications
  • Inability to swallow oral medications
  • Major surgery within 28 days before starting the study
  • Participation in other clinical trials within 4 weeks before this study
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Investigated drugs

Cisplatin is a chemotherapy medication used to treat various types of cancer. It works by interfering with cancer cell DNA, preventing the cells from dividing and growing. Gemcitabine is a chemotherapy drug that works by preventing cancer cells from making and repairing DNA, which stops them from multiplying. It is commonly used to treat several types of cancer, including bile duct cancer. Durvalumab is an immunotherapy medication that helps the immune system fight cancer cells. It works by blocking a protein that cancer cells use to hide from the immune system, allowing the body's natural defenses to better recognize and attack the cancer. Radioembolization (also known as TARE) is a treatment procedure where tiny radioactive beads are delivered directly to liver tumors through blood vessels. This allows for targeted radiation therapy while sparing healthy tissue.

What is already known about the treatment

  • Cisplatin

    A platinum-based chemotherapy medication administered intravenously that works by binding to DNA and preventing cancer cell division. It is widely used in oncology and has established efficacy in treating various cancers, including cholangiocarcinoma. Cisplatin interferes with DNA replication in rapidly dividing cells and belongs to the alkylating agents class of chemotherapy drugs.

  • Gemcitabine

    An intravenously administered chemotherapy medication that belongs to the antimetabolite class of drugs. It works by replacing one of the building blocks of nucleic acids, thereby preventing cancer cells from making and repairing DNA, which leads to cell death. Gemcitabine is commonly used in combination with cisplatin for treating various cancers, including cholangiocarcinoma.

  • Durvalumab

    An immunotherapy medication administered through intravenous infusion that belongs to the class of immune checkpoint inhibitors. It works by blocking the PD-L1 protein on cancer cells, which helps the immune system recognize and attack cancer cells more effectively. Durvalumab is used in various cancer treatments and is being studied in combination with other therapies for improved treatment outcomes.

Investigated diseases

Intrahepatic Cholangiocarcinoma - A type of cancer that develops in the bile ducts within the liver. It begins in the small bile duct branches inside the liver, where cells start to grow abnormally and form tumors. The disease typically develops slowly over time, gradually affecting the liver's ability to function normally. The condition causes the bile ducts to become blocked or narrowed, affecting the flow of bile from the liver. As it progresses, the cancer can spread to nearby liver tissue and may affect surrounding organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516498-57-00Protocol codePM-CAREEstimated enrolment28 patientsSponsorOspedale San Raffaele S.r.l.

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