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New treatment option for Hilar Cholangiocarcinoma
Official title Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Photodynamic Therapy
ClinicalTrials.gov ID: NCT05551299
What this study is testing
What is Photosensitizer?
Photosensitizer is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for hilar cholangiocarcinoma.
Also referred to as Photodynamic therapy (PDT).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Bile duct cancer is often diagnosed after curative options are no longer available. Stent therapy is used to keep the ducts open and can be combined with photodynamic therapy (PDT) to extend life expectancy.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Hilar cholangiocarcinoma (cytological or histological confirmation)
- Surgery is not planned
- Age ≥ 18 years
- Written informed consent
You likely can't join if
- Tumour not accessible endoscopically
- Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen
- Leukopenia (\< 2000/mm3)
- Thrombocytopenia (\< 100,000 / mm³)
- Severe, uncorrected coagulopathy (at the discretion of the physician)
- Suspected erosion of major blood vessels, because of the risk of life-threatening mass haemorrhage exists
See the full eligibility criteria
- Hilar cholangiocarcinoma (cytological or histological confirmation)
- Surgery is not planned
- Age ≥ 18 years
- Written informed consent
- Tumour not accessible endoscopically
- Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen
- Leukopenia (\< 2000/mm3)
- Thrombocytopenia (\< 100,000 / mm³)
- Severe, uncorrected coagulopathy (at the discretion of the physician)
- Suspected erosion of major blood vessels, because of the risk of life-threatening mass haemorrhage exists
- Porphyria (clinician's assessment) or other light-exacerbated diseases
- Severely impaired liver and or kidney function (at the discretion of the physician)
- Bedridden for more than 50% of the time (similar to ECOG (Eastern Cooperative Oncology Group) grade 3)
- Planned surgical procedure within the next 30 days
- Concurrent eye disease that will require a slit lamp examination within the next 30 days
- Prior radiotherapy within the last four weeks
- Previous PDT or RFA
- Planned liver transplantation
- Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the...
- Participation in other treatment trials
- Patients under legal supervision or guardianship
- Pregnant or nursing women
The study team makes the final eligibility decision.
Where it's taking place
- Aachen, Germany
- Augsburg, Germany
- Berlin, Germany
- Bonn, Germany
- Frankfurt, Germany
- Freiburg im Breisgau, Germany
- Greifswald, Germany
- Halle, Germany
- Hanau, Germany
- Hanover, Germany
- Leipzig, Germany
- Ludwigsburg, Germany
- Mannheim, Germany
- Marburg, Germany
- München, Germany
- Münster, Germany
- Nuremberg, Germany
- Stuttgart, Germany
- Tübingen, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aachen, Germany; Augsburg, Germany; Berlin, Germany; Bonn, Germany; Frankfurt, Germany; Freiburg im Breisgau, Germany and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.