Photodynamic Therapy for Palliation of Unresectable Cholangiocarcinoma A Multicenter, Open Label, Randomized, Controlled Phase III Trial

Inclusion Criteria:

- Patient is age 18 years or older

- Patient is diagnosed with non-resectable cholangiocarcinoma, as determined by CT
within 30 days of enrollment and CT shows Bismuth Tumor Stage as: IIIa, IIIb, IV
(Bismuth tumor stage I and II are not eligible to participate)

- Patients must have adequate organ and marrow function as defined below:

- Patient's INR ≤ 2 within 30 days of treatment

- Patient's platelets > 50,000/cmm within 30 days of treatment

- Patient's Absolute Neutrophil Count (ANC) > 1,500/cmm within 30 days of
treatment

- Patient's creatinine ≤ 3 mg/dL within 30 days of treatment

- Patient has the ability to understand and the willingness to comply with the study
procedures and provide written informed consent to participate in the study

Exclusion Criteria:

- Patient was diagnosed with cholangiocarcinoma more than 3 months ago

- Patient has any metastatic disease

- Patient has acute porphyria

- Subjects exhibiting neurologic or cutaneous symptoms will undergo urinary
delta-aminolevulinic acid and porphobilinogen dosage tests to determine severity.

- Patient is pregnant (Women of child bearing age must have a negative pregnancy test
prior to registration and must agree to use adequate contraception during study
therapy)

- Patient has a concurrent non solid malignancy