Study on Pre-Surgery Treatment for Locally Advanced Cholangiocarcinoma Using Durvalumab, Tremelimumab, Cisplatin, and Gemcitabine

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What is this study about?

This clinical trial is focused on studying a type of cancer called cholangiocarcinoma, which affects the bile ducts. The study is exploring a treatment approach that combines chemotherapy and immunotherapy before surgery. The medications being tested include durvalumab and tremelimumab, which are types of immunotherapy, as well as cisplatin and gemcitabine, which are chemotherapy drugs. The purpose of the study is to see if this combination of treatments can reduce the chance of the cancer coming back after surgery.

Participants in the study will receive these medications through an infusion, which means the drugs are given directly into the bloodstream. The treatment will be administered over a period of time before the planned surgery. The study will monitor the effects of the treatment on the cancer and assess the safety of the medications. The goal is to understand if this approach can improve outcomes for patients with locally advanced cholangiocarcinoma.

The study will also collect information on how long patients live without the cancer getting worse and overall survival rates. This information will help researchers understand the potential benefits and risks of using this combination of treatments for cholangiocarcinoma. The study is expected to continue until 2025, providing valuable insights into the effectiveness of this treatment strategy.

1 initial visit and consent

Upon joining the study, the first step involves an initial visit where the patient provides written informed consent. This consent confirms understanding and agreement to comply with the study requirements and restrictions.

During this visit, eligibility is confirmed based on specific criteria, including age, health status, and medical history related to locally advanced cholangiocarcinoma.

2 treatment phase

The treatment phase involves receiving medications through an infusion. The medications used in this study are durvalumab, cisplatin, gemcitabine, and tremelimumab.

The exact dosage, frequency, and duration of administration will be determined by the study protocol and communicated during the treatment phase.

3 monitoring and follow-up

Throughout the trial, regular monitoring and follow-up visits are scheduled to assess the patient’s response to treatment and to monitor for any side effects.

These visits may include physical examinations, blood tests, and imaging studies such as CT scans or MRIs to evaluate the tumor’s response to the treatment.

4 surgery and post-operative assessment

After completing the treatment phase, surgery is performed to remove the tumor. The primary objective is to determine if the treatment reduces the recurrence rate of cholangiocarcinoma 12 months after surgery.

Post-operative assessments are conducted to evaluate recovery and to monitor for any signs of cancer recurrence.

5 final evaluation

The final evaluation involves a comprehensive assessment of the patient’s health status and the effectiveness of the treatment.

This includes calculating the proportion of patients with cholangiocarcinoma recurrence at 12 months post-surgery and analyzing the data to ensure the safety and efficacy of the treatment.

Who Can Join the Study?

Capable of giving signed informed consent, which means you understand the study and agree to follow its rules.
Have a confirmed diagnosis of cholangiocarcinoma (CCA), a type of cancer.
Must be over 18 years old.
Have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
Initially, the cancer cannot be removed by surgery, as determined by a team of doctors. This includes:
- Tumor is close to the remaining liver.
- Tumor is close to or affecting the portal vein, a major vein in the liver.
- Tumor has up to three small spread areas in the remaining liver.
- Involvement of nearby lymph nodes.
Have a life expectancy of at least 16 weeks.
Weigh more than 30 kg (about 66 pounds).
Have normal organ and bone marrow function, which includes:
- Haemoglobin level of at least 9.0 g/dL, which is a measure of red blood cells.
- Absolute neutrophil count (ANC) of at least 1.5 x 10⁹/L, which is a type of white blood cell.
- Platelet count of at least 100 x 10⁹/L, which helps with blood clotting.
- Serum bilirubin level of no more than 1.5 times the normal limit, unless you have a condition called Gilbert’s syndrome.
- AST (SGOT)/ALT (SGPT) levels no more than 2.5 times the normal limit, unless there are liver metastases, in which case it must be no more than 5 times the normal limit.
- Creatinine clearance greater than 40 mL/min, which measures kidney function.
Have at least one tumor that can be measured by a CT or MRI scan within 28 days before starting the study.
No previous treatments for the cancer, including chemotherapy, radiation, or other local treatments.

Who Cannot Join the Study?

Patients with any other type of cancer besides locally advanced cholangiocarcinoma cannot participate. Cholangiocarcinoma is a type of cancer that forms in the bile ducts.
Patients who have had any other cancer treatment in the past 5 years are not eligible.
Patients with severe heart disease or heart failure cannot join the study. Heart failure means the heart is not pumping blood as well as it should.
Patients with uncontrolled high blood pressure are excluded. Uncontrolled high blood pressure means blood pressure that is not managed well with medication or lifestyle changes.
Patients with active infections, such as HIV or hepatitis, cannot participate. HIV is a virus that attacks the immune system, and hepatitis is an inflammation of the liver.
Pregnant or breastfeeding women are not allowed to join the study.
Patients who are unable to follow the study procedures or attend study visits are excluded.
Patients with a history of drug or alcohol abuse in the past year cannot participate.
Patients who have participated in another clinical trial within the last 30 days are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Ente Ecclesiastico Ospedale Generale Regionale Miulli	Acquaviva Delle Fonti	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
San Camillo Forlanini Hospital	Rome	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Ajxugru Ugh Iermk Do Rbdyvf Ewgjhr	Reggio Emilia	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	05.04.2023

Trial locations

Investigated drugs:

Durvalumab is a type of immunotherapy medication used in this clinical trial. It works by helping your immune system recognize and attack cancer cells more effectively. This medication is designed to block a specific protein that cancer cells use to hide from the immune system, allowing your body to better fight the cancer.

Tremelimumab is another immunotherapy medication included in the trial. Similar to durvalumab, it helps your immune system target and destroy cancer cells. Tremelimumab works by blocking a different protein that can prevent the immune system from attacking cancer cells, thereby enhancing the body’s natural ability to combat the cancer.

Investigated diseases:

Cholangiocarcinoma

Cholangiocarcinoma – Cholangiocarcinoma is a type of cancer that forms in the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and small intestine. It is characterized by the abnormal growth of cells in the bile duct lining. As the disease progresses, it can cause blockages in the bile ducts, leading to jaundice, which is a yellowing of the skin and eyes. Patients may also experience abdominal pain, weight loss, and general fatigue. The disease can spread to nearby organs and tissues, complicating its progression. Over time, the cancerous cells can invade other parts of the body, further affecting the patient’s health.

Trial ID:

2024-518656-23-00

NCT ID:

NCT06341764

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Pre-Surgery Treatment for Locally Advanced Cholangiocarcinoma Using Durvalumab, Tremelimumab, Cisplatin, and Gemcitabine

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?