Comparing two treatments for non-resectable bile duct cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of photodynamic therapy (PDT) and radiofrequency ablation (RFA) in treating patients with non-resectable hilar cholangiocarcinoma, a type of bile duct cancer. Patients will receive either PDT, which involves a photosensitizer and light application to kill cancer cells, or RFA, which uses heat to destroy cancer cells. The study will assess survival rates, side effects, and quality of life for participants. This trial is significant as it seeks to provide insights into the more widely available RFA technology compared to the less accessible PDT.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Hilar cholangiocarcinoma (cytological or histological confirmation)
2. Surgery is not planned
3. Age ≥ 18 years
4. Written informed consent

Exclusion Criteria:

1. Tumour not accessible endoscopically
2. Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen
3. Leukopenia (\< 2000/mm3)
4. Thrombocytopenia (\< 100,000 / mm³)
5. Severe, uncorrected coagulopathy (at the discretion of the physician)
6. Suspected erosion of major blood vessels, because of the risk of life-threatening mass haemorrhage exists
7. Porphyria (clinician's assessment) or other light-exacerbated diseases
8. Severely impaired liver and or kidney function (at the discretion of the physician)
9. Bedridden for more than 50% of the time (similar to ECOG (Eastern Cooperative Oncology Group) grade 3)
10. Planned surgical procedure within the next 30 days
11. Concurrent eye disease that will require a slit lamp examination within the next 30 days
12. Prior radiotherapy within the last four weeks
13. Previous PDT or RFA
14. Planned liver transplantation
15. 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 trial (participants using a hormone-based method have to be informed of possible effects of the trial medication on contraception)
16. Participation in other interventional trials
17. Patients under legal supervision or guardianship
18. Pregnant or nursing women

Where it's running

• Uniklinik RWTH Aachen, Medizinische Klinik III
  Aachen, Germany Recruiting
• Universitätsklinikum Augsburg; III. Med. Klinik
  Augsburg, Germany Recruiting
• Universitatsklinikum Bonn, Medizinische Klinik und Poliklinik I
  Bonn, Germany Recruiting
• Universitätsklinikum Freiburg, Medizinische Klinik II, Abteilung Gastroenterologie, Hepatologie, Endokrinologie & lnfektiologie
  Freiburg im Breisgau, Germany Recruiting
• Universitätsmedizin Greifswald Klinik für Innere Medizin A
  Greifswald, Germany Recruiting
• Site: Martin-Luther-Universitat Halle-Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I
  Halle, Germany Recruiting

Study contacts

• Principal investigator: Albrecht Hoffmeister, Prof.Dr.med. — Universitätsklinikum Leipzig; Bereich Gastroenterologie
• Study coordinator: Albrecht Hoffmeister, Prof.Dr.med.
• Email: albrecht.hoffmeister@medizin.uni-leipzig.de
• Phone: +49-341-97-12240

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Blood test using cfDNA methylation to screen for biliary tract cancers

  This study tests whether a blood test that reads cfDNA methylation can detect biliary tract cancers early in adults with or suspected of having these cancers.

  Recruiting Shanghai Jiao Tong University School of Medicine · Shanghai, Shanghai Municipality · NCT07176962

• Preoperative Lymph Node Assessment in Cholangiocarcinoma using Endoscopic Ultrasound

  This study tests how well preoperative endoscopic ultrasound (EUS) finds lymph node metastases in adults with presumed resectable or certain unresectable cholangiocarcinomas to see if surgery should proceed.

  Recruiting Erasmus Medical Center · Rotterdam, South Holland and 5 other locations · NCT07161869

• Neoadjuvant tislelizumab with SBRT and gemcitabine/platinum chemotherapy for borderline or unresectable hilar bile duct cancer

  This trial will see if precise radiotherapy (SBRT) followed by the PD‑1 drug tislelizumab plus gemcitabine and platinum chemotherapy can shrink tumors enough to allow surgery and improve survival in people with borderline resectable or unresectable hilar cholangiocarcinoma.

  Recruiting Phase 2 Shandong Cancer Hospital and Institute · Jinan, Shandong · NCT07030140

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.