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

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.

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)