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 perihilarcholangiocarcinoma Bismuth Tumor Stage III/IV

• Non-menopausal or non-sterile female subjects of childbearing potential must have anegative 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 tostudy 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 enteringthe 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 duringthis 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