A Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection

Inclusion Criteria:

* Subjects undergoing curative surgical resection for cholangiocarcinoma (including cancer of the gallbladder \[except stage I\], intrahepatic, and extrahepatic bile duct)
* Histological confirmation is mandatory.
* Age over 18 years old
* Performance status (ECOG scale): 0-2
* Adequate organ functions Hb ≥ 9.0 g/dl ANC: ≥ 1,500/mm3 PLT ≥ 100,000 /mm3 Liver function: Total Bilirubin ≤ 2.0 mg/dl AST / ALT / ALP ≤ 3× upper limit of normal Creatinine ≤ 1.5 ULN
* Patients should sign a written informed consent before study entry.

Exclusion Criteria:

* Tumor type other than adenocarcinoma
* Stage I gallbladder cancer
* Noncurative surgical resection including R2 resection
* Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
* Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy)
* Prior radiotherapy
* Major surgery within 4 weeks prior to study treatment except for surgical resection of cholangiocarcinoma
* Serious illness or medical conditions, as follows; congestive heart failure (NYHA class III or IV) unstable angina or myocardial infarction within the past 6 months, significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block uncontrolled hypertension hepatic cirrhosis(≥ Child class B) interstitial pneumonia, pulmonary adenomatosis psychiatric disorder that may interfere with and/or protocol compliance unstable diabetes mellitus uncontrolled ascites or pleural effusion active infection
* Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug
* Pregnant or lactating woman
* Women of child bearing potential not using a contraceptive method
* Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
* Any patients judged by the investigator to be unfit to participate in the study