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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

3 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

  • Radiofrequency Ablation (RFA)

    RFA is a treatment method where heat generated by radio waves is used to destroy cancer cells. It is currently being studied for its effectiveness in treating hilar cholangiocarcinoma, a type of bile duct cancer. The main goal of using RFA in this context is to see if it can help patients live longer. RFA works by targeting and heating the cancerous tissue, causing it to die, and is classified as a minimally invasive procedure.

  • Photodynamic Therapy (PDT)

    PDT is a treatment that uses a drug, called a photosensitizer, along with a specific type of light to kill cancer cells. It is being explored for its potential to improve survival in patients with hilar cholangiocarcinoma. The therapy involves administering the photosensitizer, which accumulates in cancer cells, and then activating it with light, leading to the destruction of these cells. PDT is considered a targeted therapy because it specifically affects the cancerous cells while sparing most of the healthy tissue.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500107-50-00Protocol codeCARPEstimated enrolment258 patientsSponsorUniversitaet Leipzig

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