Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS)

Inclusion Criteria:

- Males or females aged 18 or older

- Diagnosed with radiologically and biopsy or cytology confirmed inoperable perihilar
cholangiocarcinoma Bismuth Tumor Stage III/IV

- Non-menopausal or non-sterile female subjects of childbearing potential must have a
negative serum beta-HCG and use a medically acceptable form of birth control

- Able to sign an informed consent

Exclusion Criteria:

- Diagnostic of cholangiocarcinoma made more than 45 days prior to randomization

- Cholangiocarcinoma with extra-hepatic metastasis or concurrent non-solid malignancy

- Presence or history of other neoplasms (treated during the last five years prior to
study entry) other than carcinoma in situ of the cervix or basal carcinoma of the skin

- Previously received photodynamic therapy for cholangiocarcinoma

- Previously undergone surgical resection of the cholangiocarcinoma

- Previously undergone chemotherapy, brachytherapy, or radiotherapy prior to entering
the study

- Previously undergone metal stent insertion

- Porphyria or hypersensitivity to porphyrins (constituents of porfimer sodium),
gemcitabine, cisplatin or other platinum-containing compounds

- Presence of infection other than the infection of the bile duct (cholangitis)

- Acute or chronic medical or psychological illnesses that prevent endoscopy procedures

- Abnormal blood test results

- Severe impairment of your kidney or liver function

- Decompensated cirrhosis

- Pregnant or intend to become pregnant, breastfeeding or intend to breast-feed during
this study

- Participated in another drug study within 90 days before this one

- Unable or unwilling to complete the follow-up evaluations required for the study