Clinical trial · Interventional
Safety and Tumoricidal Effect of Low Dose Foscan PDT in Patients With Inoperable Bile Duct Cancers
Safety and Tumoricidal Effect of Low Dose Temoporfin Photodynamic Therapy in Patients With Inoperable Bile Duct Cancers (Foscan® Study)
NCT03003065CI-TRIAL-00068968PDTcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study, we hope to evaluate the safety of PDT using temoporfin plus endoscopic stents in patients with inoperable bile duct cancers. In addition as a preliminary study we sought to determine if the treatment can reduce tumor volume in the short term.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Klatskin Tumor | Hilar Cholangiocarcinoma | ALIAS | 0.90 |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temoporfin | Drug | Temoporfin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Foscan
- description
- A single treatment with Temoporfin (Foscan) 3 mg given intravenously followed by PDT with laser light at 652 nm (Ceralas, Biolitec, Germany) within 72 hours
- interventionNames
- Drug: Temoporfin
Primary outcomes (1)
- measure
- Safety (will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0)
- timeFrame
- 10 years
- description
- Safety (will be graded according to the Common Terminology Criteria for Adverse Events
Secondary outcomes (4)
- measure
- Tumor response as categorized by the World Health Organization criteria at 8 weeks as assessed by ERCP and Intraduct ultrasound
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with inoperable cholangiocarcinoma belonging to all Bismuth Corlette classification. * Karnofsky index \>30% * Satisfactory relief of jaundice (serum bilirubin \< 100µmol/L) with biliary prostheses inserted either at ERCP or via percutaneous transhepatic routes. * Absence of biliary sepsis * Age 18-80 * Provision of written consent * No evidence of metastatic disease Exclusion Criteria: * Porphyria * Previous inserted metallic biliary stents * Refusal to provide a written consent. * Moribund from disseminated disease or comorbidities * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.