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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Universita’ Di Pisa	Pisa	Italy
Atvjlag Oniiuvajsfl Pzet Gdwvjeee Xwjjz	Bergamo	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	02.04.2024

Trial locations

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.

Investigated diseases:

Cholangiocarcinoma

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 ID:

2024-516498-57-00

Protocol code:

PM-CARE

NCT ID:

NCT06375915

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?