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Study on Durvalumab, Cisplatin, and Gemcitabine for Patients with Extrahepatic Cholangiocarcinoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called extrahepatic cholangiocarcinoma, which affects the bile ducts outside the liver. The study will explore the effects of a treatment combination that includes a medication called durvalumab (also known by its code name MEDI4736), along with chemotherapy and a procedure known as intraductal radiofrequency ablation (ID-RFA). The purpose of the study is to evaluate how effective this combination is in treating the cancer.

Participants in the study will receive durvalumab through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The chemotherapy drugs used in this study are cisplatin and gemcitabine, both of which are also given by intravenous infusion. The study will take place over a period of time, during which participants will receive these treatments and be monitored regularly by healthcare professionals.

The study aims to understand the overall survival rate of participants after 12 months, as well as other factors such as progression-free survival, safety, time to develop cholangitis (an infection of the bile duct), and quality of life. Participants will be closely observed to gather information on how well the treatment works and any side effects that may occur. This information will help researchers learn more about the potential benefits and risks of this treatment combination for people with extrahepatic cholangiocarcinoma.

1 initial treatment phase

The treatment begins with the administration of cisplatin and gemcitabine. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The dosage and frequency of these medications will be determined by the healthcare team based on individual health conditions and response to treatment.

2 durvalumab administration

Durvalumab, also known as Imfinzi, is administered as a solution for infusion. This means it is given through an intravenous infusion, similar to the previous medications.

The frequency and duration of durvalumab administration will be specified by the healthcare team, taking into account the patient’s response to the treatment.

3 intraductal radiofrequency ablation (ID-RFA)

Intraductal radiofrequency ablation (ID-RFA) is a procedure used to treat the bile ducts. It involves using heat to destroy cancer cells in the ducts.

This procedure is performed as part of the treatment plan and is coordinated with the administration of durvalumab and chemotherapy.

4 follow-up and monitoring

Regular follow-up visits are scheduled to monitor the patient’s response to the treatment. These visits may include physical examinations, blood tests, and imaging studies.

The healthcare team will assess the overall health, manage any side effects, and adjust the treatment plan as necessary.

5 end of treatment evaluation

At the end of the treatment period, a comprehensive evaluation is conducted to assess the effectiveness of the treatment.

This evaluation includes reviewing the patient’s overall survival rate, progression-free survival, and quality of life.

Who Can Join the Study?

  • The patient must have given written informed consent to participate in the study.
  • Female patients who can have children or male patients with partners who can have children must agree to avoid pregnancy by using effective birth control methods or abstaining from sex during the study and for a certain period after the last treatment. Male patients must also agree not to donate sperm during this time.
  • The patient must be 18 years of age or older at the time of giving consent.
  • The patient must be willing and able to follow the study’s requirements, including attending treatment sessions and scheduled visits.
  • The patient must have been diagnosed with a specific type of cancer called cholangiocarcinoma, which affects the bile ducts, and it must be confirmed by a medical test.
  • The patient must be eligible for palliative systemic therapy, which is treatment aimed at relieving symptoms rather than curing the disease, based on medical tests and evaluations.
  • The patient must have an ECOG score of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • The patient must have a life expectancy of at least 12 weeks.
  • The patient must weigh more than 30 kg (about 66 pounds).
  • The patient must have adequate blood, liver, and kidney function, as shown by specific medical tests, including:
    • Adequate white blood cell count without needing special medications.
    • Adequate platelet count, which helps with blood clotting.
    • Adequate hemoglobin levels, which carry oxygen in the blood.
    • Total bilirubin levels within a certain range, unless caused by a bile duct blockage.
    • Adequate albumin levels, which is a protein in the blood.
    • If not on blood thinners, certain blood clotting tests must be within normal limits.
    • Liver enzymes must be within a certain range unless there are liver metastases, which are cancer spread to the liver.
    • Serum creatinine levels and kidney function must be within a certain range.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany
Universitaetsmedizin Goettingen Goettingen Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Evangelisches Krankenhaus Duesseldorf Duesseldorf Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Kliniken der Stadt Koeln gGmbH Cologne Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Uynkyyccev Hcmrnzbg Cblnmyq Cologne Germany
Umchrvpdfqvzkntcdqchy Dvpuyqqstci Acy Duesseldorf Germany
Uvskkeywhjctifqdqwbcy Mfysolmk Agt Munster Germany

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Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
01.05.2024

Trial locations

Investigated drugs:

Durvalumab is a medication used in this trial to help the body’s immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells, allowing the immune system to better target and destroy these cells.

Intraductal Radiofrequency Ablation (ID-RFA) is a therapy used in this trial to treat cancer by applying heat directly to the tumor. This heat destroys cancer cells and can help shrink the tumor, making it easier for other treatments to work effectively.

Investigated diseases:

Extrahepatic Cholangiocarcinoma – This is a type of cancer that occurs in the bile ducts outside the liver. It typically begins in the cells lining the bile ducts and can cause blockages, leading to symptoms such as jaundice, itching, and abdominal pain. As the disease progresses, it may spread to nearby tissues and organs. The growth of the tumor can interfere with bile flow, causing further complications. It is often diagnosed at an advanced stage due to the subtlety of early symptoms. The progression of the disease can vary, with some cases advancing more rapidly than others.

Trial ID:
2023-509165-21-00
Protocol code:
CLEAN-DUCT
Trial Phase:
Therapeutic exploratory (Phase II)

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