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 o…