Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II, Open-label, Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma

Conditions
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Non-curative Resectable Bile Duct Carcinoma

Intervention / Treatment
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* Drug: Temoporfin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension: Bismuth type III or IV ( not resectable with R0-margins ) 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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Drug: Temoporfin<br>* Drug treatment: Temoporfin 0.15 mg/kg body weight, intravenous injection within at least 6 min. Laser Treatment: 652nm wavelength; 30 Joules/cm diffusor length ( 200 sec at 150mW/cm diffusor length), within 96 h after Foscan<br>* Other names: Meso-tetrahydroxyphenyl Chlorin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT |  | post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival time, overall survival time |  | Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention | 
| Toxicity using WHO criteria and criteria for local toxicity in the biliary system |  | Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention |