Study on Hilar Cholangiocarcinoma Treatment Using Porfimer Sodium and Foscan for Patients with Bile Duct Cancer

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What is this study about?

This clinical trial is focused on studying the treatment of cholangiocarcinoma, a type of cancer that occurs in the bile ducts. The study is exploring two treatment methods: radiofrequency ablation and photodynamic therapy. Photodynamic therapy involves using a special drug called Porfimer Sodium, which is a photosensitizer, meaning it becomes active when exposed to light. Another drug used in this study is Foscan, which is administered as a solution for injection.

The purpose of the study is to determine whether photodynamic therapy or radiofrequency ablation leads to longer survival for patients with cholangiocarcinoma. Participants in the study will receive one of these treatments, and their progress will be monitored over time. The study will look at various aspects of the patients’ health, including their overall survival, quality of life, and how long they remain out of the hospital. The study will also consider other factors like the effectiveness of stents, which are small tubes used to keep the bile ducts open, and any changes in laboratory test results.

The study is expected to continue until the end of 2027, with the aim of gathering comprehensive data on the effectiveness of these treatments. By participating in this study, researchers hope to gain valuable insights into which treatment option may offer better outcomes for patients with cholangiocarcinoma.

1 joining the study

Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate after understanding the details of the study.

You must be 18 years or older and have a confirmed diagnosis of hilar cholangiocarcinoma. Surgery should not be planned for your condition.

2 randomization

You will be randomly assigned to one of two treatment groups: radiofrequency ablation (RFA) or photodynamic therapy (PDT).

This process ensures that each participant has an equal chance of receiving either treatment.

3 treatment administration

If assigned to the PDT group, you will receive a medication called porfimer sodium. This is administered as a solution for injection.

The medication will be given through an infusion or injection, as determined by the medical team.

4 follow-up and monitoring

Your overall survival will be monitored, which means tracking the time from when you start the study to either the end of the study or your last known date of being alive.

Your quality of life will be assessed at various points: 14 days after starting, around 3 months, and then periodically after 6 months.

Other factors like days spent out of the hospital, stent function, and any itching will be evaluated over a period of up to two years.

5 end of study

The study is expected to conclude by December 31, 2027.

At the end of the study, the results will be analyzed to determine if either treatment leads to longer survival.

Who Can Join the Study?

  • Must have a diagnosis of hilar cholangiocarcinoma, confirmed by a test that examines cells or tissues.
  • Surgery is not planned for the treatment.
  • Must be 18 years of age or older.
  • Must provide written informed consent, which means you agree to participate after being fully informed about the study.

Who Cannot Join the Study?

  • Patients with any other type of cancer besides hilar cholangiocarcinoma cannot participate. Hilar cholangiocarcinoma is a type of cancer that occurs in the bile ducts near the liver.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Medicine Greifswald Greifswald Germany
Universitaetsmedizin Goettingen Goettingen Germany
Universitaet Leipzig Leipzig Germany

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR Stuttgart Germany
Klinikum St. Georg gGmbH Leipzig Germany
Philipps-Universitaet Marburg Marburg Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Klinikum Hanau GmbH Hanau Germany
Robert Bosch Krankenhaus GmbH Stuttgart Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Klinikum Region Hannover GmbH Hanover Germany
Heidelberg University Mannheim Germany
RKH Klinken Ludwigsburg-Bietigheim gGmbH Ludwigsburg Germany
Westfaelische Wilhelms Universitaet Muenster Munster Germany
Ujsxwnnlqfpcugknwjowm Kpmagwbfhkoritivafryqjm Bdipcj Gabz Bochum Germany
Vrcqtexp Nvcvavhp fgig Gmhvnewcza Gikx Berlin Germany
Gcjowt Uotobmbvzs Faxgqvyrl Frankfurt Germany
Kpskjmlk dwp Uyweorfepcmd Mxrfgvcf Asv Munich Germany
Mnocmvfdygzidvzixlmcfvmysn Hbnuumjejzwghpih Halle (Saale) Germany
Untryrgdcgjbqkfhtzsev Adoqdith Augsburg Germany

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

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
01.06.2022

Trial locations

Radiofrequency Ablation (RFA) is a treatment that uses heat to destroy cancer cells. A special needle is inserted into the tumor, and then radio waves are used to heat the area, which kills the cancer cells. This method is often used to treat tumors that cannot be removed with surgery. In this trial, RFA is being tested to see if it can help people with cholangiocarcinoma live longer.

Photodynamic Therapy (PDT) is a treatment that uses a special drug and a certain type of light to kill cancer cells. The drug is injected into the bloodstream and is absorbed by the cancer cells. After a certain amount of time, the doctor shines a light on the cancer, which activates the drug and destroys the cancer cells. This therapy is being studied in this trial to determine if it can improve survival rates for patients with cholangiocarcinoma.

Investigated diseases:

Hilar cholangiocarcinoma – Hilar cholangiocarcinoma is a type of cancer that occurs at the junction of the right and left hepatic bile ducts. It begins in the cells lining the bile ducts and can cause obstruction, leading to jaundice and liver dysfunction. As the disease progresses, it can invade nearby structures such as the liver, blood vessels, and lymph nodes. This cancer often grows slowly but can spread to other parts of the body over time. Symptoms may include abdominal pain, weight loss, and changes in liver function tests. The progression of the disease can lead to complications such as infections and liver failure.

Trial ID:
2022-500107-50-00
Protocol code:
CARP
NCT ID:
NCT05551299
Trial Phase:
Therapeutic confirmatory (Phase III)

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