Efficacy and Safety Study of PDT Using Deuteporfin for Unresectable Advanced Perihilar Cholangiocarcinoma

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.
* KPS≥70.
* Total Bilirubin\<85.5 umol/L.
* Informed consent obtained.

Exclusion Criteria:

* The first diagnosis time of cholangiocarcinoma \> 3 months before randomization.
* Expected survival \<3 months.
* Patients with abnormal laboratory parameters: white blood cell\<3.0×10(9)/L；hemoglobin \<80g/L；Neutrophil Differential Count\<1.5×10(9)/L；blood platelets\<75×10(9)/L；or patients have other diseases of the blood system.
* Creatinine clearance \>1.5×upper limit of normal range.
* Patients with severe liver function damage，or aspartate transaminase (AST) and/or alanine transaminase (ALT) \>5×upper limit of normal range.
* Patients have intrahepatic metastasis, or distant metastasis (including distant lymph node metastasis); or bile duct cancer patients with other parts of the primary malignant tumor.
* Patients have activities of viral hepatitis, liver cirrhosis, liver abscess, alcoholic fatty liver, primary hepatocellular carcinoma, and other liver diseases; or patients have immunoglobulin G4 (IgG4) sclerosing cholangitis, primary sclerosing cholangitis, autoimmune cholangitis, and other cholangitis.
* Malignancies other than cholangiocarcinoma within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer.
* Patients had received PDT treatment prior to randomization.
* Patients had received bile duct carcinoma resection prior to randomization.
* Patients had received chemotherapy, or brachytherapy，or radiotherapy prior to randomization.
* Patients had received metal stent treatment prior to randomization.
* Presence of infection (active, untreated infection and/or acute bacterial or fungal infection) other than the infection of the bile duct (cholangitis).
* Uncontrolled severe hypertension \[sitting systolic blood pressure (SBP) \>180 mmHg and/or sitting diastolic blood pressure (DBP) \>110 mmHg after medication\]; have severe complications of hypertension or diabetes.
* Presence of severe heart, lung and central nervous system diseases.
* Presence of mental illness, or mental disorders can not accurately describe their feelings, or not according to the doctor's advice to take medication.
* History of alcohol abuse, drug abuse in the past 1 years.
* Presence of allergic diseases，or known to have light skin allergies or porphyria, or known to allergic to study drug(porphyrin drugs) or other similar compounds, cephalosporin antibiotics, other types penicillin, β lactamase inhibitors.
* Patients need to use prohibited drugs in proposal during the first 2 weeks of screening, or during the trial period.
* Patients having been enrolled in other clinical trial within 3 months prior to this clinical trial.
* Pregnant, lactating women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
* The researchers weren't allowed to participate in this study as subjects.
* Patients unsuitable for enrollment in the clinical trial according to investigators decision.