An Open-label, single arm Phase II Trial of Photodynamic Therapy using Foscan for non-curatively-resectable bile duct carcinoma - Foscan-PDT-protocol for BDC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004866-17-DE

Enrollment

Registered

2005-11-22

Start date

2007-04-03

Completion date

Unknown

Last updated

2013-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonresectable hilar or extrahepatic bile duct carcinoma in clinical stage MO ( without liver or peritoneal metastases according to clinical or surgical staging)

Interventions

Pharmaceutical Form: Solution for injection INN or Proposed INN: Temoporfin CAS Number: 122341-38-2 Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 4-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension: a) Bismuth type 111 or IV ( not resectable with RO-margins ), b) 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 2 30%) * age> 19 years * access to common bile duct (either via endoscopy after sphincterotomy or percutaneously after transhepatic drainage), * informed written consent for PDT. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 ) * accompaning/complicating disease with very poor prognosis (expected survival < 6 weeks), * proven advanced peritoneal carcinomatosis (PET scan imaging, ascites positive for tumor cells)

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess Foscan (temoporfiin) photodynamic therapy tumorocidal penetration greater than 8mm. To assess efficacy and safety of Foscan (temoporfiin) photodynamic therapy in the treatment of locally advanced hilar or extrahepatic bile duct carcinoma without distant metastases.;Secondary Objective: - Progression-free survival time, overall survival time - Rate of systemic response (RECIST criteria / EORTC)(37). - Toxicity using WHO criteria and criteria for local toxicity in the biliary system;Primary end point(s): Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT	—

Measure

Time frame

Main Objective: To assess Foscan (temoporfiin) photodynamic therapy tumorocidal penetration greater than 8mm. To assess efficacy and safety of Foscan (temoporfiin) photodynamic therapy in the treatment of locally advanced hilar or extrahepatic bile duct carcinoma without distant metastases.;Secondary Objective: - Progression-free survival time, overall survival time - Rate of systemic response (RECIST criteria / EORTC)(37). - Toxicity using WHO criteria and criteria for local toxicity in the biliary system;Primary end point(s): Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026