Clinical trial · Interventional
Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma
A Phase II, Open-label, Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma
NCT01016002CI-TRIAL-00002783unknownPhase 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)
The purpose of this study is to assess efficacy and safety of Foscan (temoporfin) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-curative Resectable Bile Duct Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temoporfin | Drug | Temoporfin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- interventionNames
- Drug: Temoporfin
Primary outcomes (1)
- measure
- Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT
- timeFrame
- post treatment
Secondary outcomes (2)
- measure
- Progression-free survival time, overall survival time
- timeFrame
- Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention
- measure
- Toxicity using WHO criteria and criteria for local toxicity in the biliary system
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension: 1. Bismuth type III or IV ( not resectable with R0-margins ) 2. Bismuth type I or II, if resective surgery is contraindicated for old age or poor surgical risk of patient * sufficient general condition to undergo PDT (Karnofsky status \> 30%) * age \> 19 years * access to common bile duct (either via endoscopy after sphincterotomy or percutaneously after transhepatic drainage), * informed written consent Exclusion Criteria: * porphyria or other diseases exacerbated by light * known intolerance or allergies to porphyrin derivatives * a planned surgical procedure within the next 30 days * coexisting ophthalmic disease likely to require slit lamp examination within the next 30 days * impaired kidney or liver function (creatinine \> 2.5x elevated, INR \> 2.2 on vitamin K), * leukopenia ( WBC \< 2000/cmm ) or thrombopenia ( \< 50000/cmm ), * cytotoxic chemotherapy within the past 4 weeks. * pregnancy ( and safe contraception for 6 months after PDT ) * accompanying/complicating disease with very poor prognosis (expected survival \< 6 weeks), * proven advanced peritoneal carcinomatosis ( PET scan imaging, ascites positive for tumor cells)
References
Publications (0)
Data not yet available
No reference posted for this study.