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Study on Preoperative Treatment with Gemcitabine, Cisplatin, Durvalumab, and Tremelimumab for Patients with Intrahepatic Cholangiocarcinoma

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What is this study about?

This clinical trial is focused on studying a type of liver cancer called intrahepatic cholangiocarcinoma. The study will explore the effects of a combination of medications used before surgery. These medications include Gemcitabine and Cisplatin, which are chemotherapy drugs, along with Durvalumab (also known by its code name MEDI4736) and Tremelimumab. The purpose of the study is to assess the safety and feasibility of this treatment combination in patients with intrahepatic cholangiocarcinoma.

Participants in the study will receive the treatment through an infusion, which means the medication is delivered directly into the bloodstream. The study will take place over several weeks, during which the effects of the treatment will be monitored. The goal is to see if this combination of drugs can help make the cancer more manageable and improve the chances of successful surgery. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

The study aims to achieve a high rate of successful tumor removal through surgery, known as R0/R1 resection, in more than 65% of participants. Researchers will also look at other outcomes, such as how well the cancer responds to the treatment, the safety of the treatment, and the overall quality of life of the participants during and after the study. This trial is an important step in finding more effective treatments for intrahepatic cholangiocarcinoma.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, a physical examination, and necessary imaging tests such as a CT scan or MRI to evaluate the tumor.

Blood tests are performed to ensure normal organ and marrow function. A pregnancy test is required for women of childbearing potential.

2 treatment phase

The treatment phase involves receiving a combination of medications through intravenous infusion. The medications include gemcitabine hydrochloride, cisplatin, durvalumab, and tremelimumab.

The specific dosage and frequency of administration are determined by the study protocol. This phase aims to assess the safety and effectiveness of the treatment combination.

3 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess the response to treatment and any side effects. This includes periodic imaging tests and blood work.

Participants are required to attend scheduled follow-up visits to ensure ongoing evaluation of health status and treatment outcomes.

4 surgery evaluation

After completing the treatment phase, an evaluation is conducted to determine the possibility of surgical removal of the tumor. This is based on the response to the treatment and the resectability of the tumor.

The goal is to achieve a successful surgical outcome, referred to as R0/R1 resection, which indicates the complete or near-complete removal of the tumor.

5 post-treatment follow-up

Following surgery, participants continue to be monitored for any recurrence of the disease and overall health status. This includes regular medical check-ups and imaging tests.

The study aims to gather data on long-term outcomes, including quality of life and any potential side effects from the treatment.

Who Can Join the Study?

  • Must have a life expectancy of at least 12 weeks.
  • Body weight must be more than 30 kg (about 66 pounds).
  • Must have normal functioning of organs and bone marrow, as defined in the study protocol.
  • Women who are post-menopausal for more than two years can participate. Women who can have children must be surgically sterile or have a negative pregnancy test within 7 days before the trial. They must agree to use effective birth control during the study and for 180 days after the last dose of study drugs.
  • Men must agree to use birth control methods or remain abstinent during the study and for 180 days after the last dose of study drugs. They should not donate sperm during this time.
  • Must be able to understand the nature, importance, and personal consequences of the clinical trial.
  • Must have sufficient language skills to understand verbal and written information and be able to give signed informed consent.
  • Must be older than 18 years.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest.
  • Must have at least one tumor lesion that has not been treated before and qualifies as a target lesion for measurement. This must be confirmed by a CT scan or MRI within 28 days before starting treatment.
  • Must have a confirmed diagnosis of intrahepatic cholangiocarcinoma (iCCA) and available tumor tissue for research purposes.
  • The primary tumor must be technically removable by surgery.
  • Must not have had any prior systemic or local therapy, or any partial or complete tumor removal surgery for iCCA.

Who Cannot Join the Study?

  • Patients with any other type of cancer besides intrahepatic cholangiocarcinoma cannot participate. This is a type of cancer that starts in the bile ducts inside the liver.
  • Patients who have had a different cancer in the past, unless it was a type that is not expected to come back, cannot participate.
  • Patients with serious heart problems cannot participate.
  • Patients with serious lung problems cannot participate.
  • Patients with an active infection that needs treatment cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have had an organ transplant cannot participate.
  • Patients who are taking certain medications that affect the immune system cannot participate.
  • Patients with a known allergy to the study drugs cannot participate.
  • Patients with a history of autoimmune diseases, which are conditions where the immune system attacks the body, cannot participate.
  • Patients who have participated in another clinical trial within the last 4 weeks cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany

Other Sites

Site Name City Country Status
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Uelmytlepo Mxgpvsd Ckatgv Hfxrivgcjmvhxfruv Hamburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
27.06.2023

Trial locations

Investigated drugs:

Gemcitabine is a type of chemotherapy medication used to treat various types of cancer. In this trial, it is used to help shrink the tumor before surgery. It works by slowing or stopping the growth of cancer cells.

Cisplatin is another chemotherapy drug that is used alongside Gemcitabine. It helps to kill cancer cells and is used to make the tumor smaller and easier to remove during surgery.

Durvalumab is an immunotherapy drug. It helps your immune system recognize and attack cancer cells. In this trial, it is used to boost the body’s natural defenses to fight the cancer more effectively.

Tremelimumab is also an immunotherapy medication. It works by helping the immune system to better identify and destroy cancer cells. It is used in combination with Durvalumab to enhance the immune response against the cancer.

Investigated diseases:

Intrahepatic cholangiocarcinoma – Intrahepatic cholangiocarcinoma is a type of cancer that originates in the bile ducts within the liver. It begins when cells in the bile ducts undergo changes and start to grow uncontrollably, forming a tumor. As the disease progresses, the tumor can grow larger and may spread to nearby tissues or organs. The growth of the tumor can obstruct bile flow, leading to symptoms such as jaundice, abdominal pain, and weight loss. Over time, the cancer may invade blood vessels and lymph nodes, further complicating the condition. The progression of the disease can vary, with some tumors growing slowly while others may advance more rapidly.

Trial ID:
2024-515660-31-00
Trial Phase:
Therapeutic exploratory (Phase II)

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