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Study on the Effectiveness and Safety of Gemcitabine, Cisplatin, Trastuzumab, and Pembrolizumab for Untreated HER2-Positive Biliary Tract Cancer Patients

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What is this study about?

This clinical trial is focused on studying a type of cancer known as HER2-positive biliary tract cancer, which includes cancers like cholangiocarcinoma and gallbladder carcinoma. The study will explore the effectiveness and safety of a combination treatment involving several medications. These medications are Gemcitabine, Cisplatin, Trastuzumab, and Pembrolizumab. The purpose of the study is to assess how well this combination works in treating the cancer and to monitor any side effects that may occur.

Participants in the study will receive the treatment over a period of 24 months. The treatment involves administering the medications through an intravenous infusion, which means they are given directly into the bloodstream through a vein. The study will also include a group of participants who will receive a placebo, which is a substance with no active medication, to compare the effects of the treatment. Throughout the study, participants will be regularly monitored to evaluate their response to the treatment and to ensure their safety.

The main goal is to see how many participants experience a reduction in their cancer size or symptoms after six months of treatment. The study will also look at how long participants live without the cancer getting worse and overall survival rates. Additionally, the safety of the treatment will be assessed by recording any side effects experienced by the participants. This trial aims to provide valuable information on the potential benefits and risks of using this combination of medications for treating HER2-positive biliary tract cancer.

1 initial treatment phase

Upon joining the study, the patient will begin the initial treatment phase. This involves receiving a combination of medications administered through an intravenous (IV) route.

The medications include cisplatin, pembrolizumab, trastuzumab, and gemcitabine hydrochloride. These are given as solutions for infusion, which means they are delivered directly into the bloodstream through a vein.

2 medication schedule

The patient will receive cisplatin and gemcitabine hydrochloride as part of the standard treatment regimen known as GemCis. This combination is typically administered on specific days of a treatment cycle, which will be explained by the healthcare provider.

Trastuzumab and pembrolizumab are additional medications given to enhance the treatment’s effectiveness. The exact schedule and dosage will be determined by the healthcare team based on the patient’s specific condition and response to treatment.

3 treatment duration

The treatment is planned to continue for a period of 6 months. During this time, the patient’s response to the treatment will be closely monitored.

The primary goal is to assess the effectiveness of the treatment combination in terms of the objective response rate, which refers to the proportion of patients who experience a significant reduction in tumor size or complete disappearance of the tumor.

4 monitoring and assessments

Throughout the trial, regular assessments will be conducted to monitor the patient’s health and the treatment’s impact. This includes imaging tests to evaluate tumor response and routine blood tests to check organ function.

The safety of the treatment will also be assessed by tracking any side effects or adverse events experienced by the patient.

5 follow-up phase

After completing the treatment phase, the patient will enter a follow-up phase. This involves periodic check-ups to monitor the patient’s health status and any long-term effects of the treatment.

The follow-up phase is crucial for understanding the overall outcomes of the treatment and ensuring the patient’s well-being.

Who Can Join the Study?

  • The participant must provide written informed consent, which means they agree to take part in the study after understanding what it involves.
  • The participant must have adequate organ function, as defined in the study protocol.
  • If the participant has a history of Hepatitis B or C, they must meet specific conditions:
    • For Hepatitis B, participants must have been on antiviral therapy for at least 4 weeks and have an undetectable viral load before joining the study. They should continue antiviral therapy during the study.
    • For Hepatitis C, participants must have an undetectable viral load at screening and must have completed antiviral therapy at least 4 weeks before joining the study.
  • The participant must be at least 18 years old on the day they sign the informed consent.
  • The participant must be willing and able to follow the study protocol, according to the investigator’s judgment.
  • The participant must have a confirmed diagnosis of cholangiocarcinoma or gallbladder cancer.
  • The participant must not be eligible for surgery.
  • The participant must have HER2-positive disease, which is a specific characteristic of the cancer cells, confirmed by certain tests.
  • The participant must have an ECOG performance status of 0 to 1, which is a scale used to assess how the disease affects their daily living abilities.
  • Male participants must agree to use contraception during the treatment and for at least 7 months after the last dose, and must not donate sperm during this time. Female participants must not be pregnant or breastfeeding and must agree to use contraception if they are of childbearing potential.
  • The participant must have measurable disease based on RECIST v1.1, which is a set of guidelines used to measure cancer response to treatment. Lesions in areas that were previously treated with radiation can be considered measurable if they have shown progression.

Who Cannot Join the Study?

  • Patients with other types of cancer that are not cholangiocarcinoma (a type of cancer that forms in the bile ducts) or gallbladder carcinoma (cancer that forms in the gallbladder).
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not able to provide informed consent or are considered part of a vulnerable population that requires special protection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Umiseennnzniyhbcgnwfb Aoqmvwgq Augsburg Germany
Uahxxciwkesoxksolnfkg Dyttiaqiakj Apr Duesseldorf Germany
Kjiuxpce dco Uhxmwnslaprk Mjvtkdqv Alm Munich 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
22.01.2024

Trial locations

Investigated drugs:

GemCis is a combination of two chemotherapy drugs, gemcitabine and cisplatin. These medications work together to stop the growth of cancer cells. They are commonly used as a standard treatment for various types of cancer, including biliary tract cancer.

Trastuzumab is a targeted therapy that attaches to the HER2 protein on the surface of cancer cells. By doing this, it helps to stop the growth of these cells and can also help the immune system to destroy them. It is used in cancers that have high levels of HER2, such as certain types of breast and biliary tract cancers.

Pembrolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It works by blocking a specific protein on the surface of immune cells, allowing them to better detect and fight cancer. This medication is used in various types of cancer, including those that are HER2-positive.

Investigated diseases:

Cholangiocarcinoma – This 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 often progresses slowly and may not cause symptoms until it is advanced. As the disease progresses, it can lead to jaundice, abdominal pain, and weight loss. The cancer can spread to nearby organs and tissues, complicating the condition. It is often diagnosed at a later stage due to its subtle early symptoms.

Gallbladder Carcinoma – This is a cancer that originates in the gallbladder, a small organ beneath the liver that stores bile. It typically progresses without noticeable symptoms in the early stages, making early detection challenging. As it advances, symptoms such as abdominal pain, nausea, and jaundice may appear. The cancer can invade nearby organs and spread to distant parts of the body. Its progression can lead to complications in the digestive system. The disease is often discovered incidentally during imaging tests for other conditions.

Trial ID:
2023-505722-33-00
Protocol code:
TRAP-BTC
Trial Phase:
Therapeutic exploratory (Phase II)

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