• Histologically confirmed BTC (intrahepatic, hilar or distal CCA, or muscle invasive GBCA) after surgical therapy with macroscopically complete resection (mixed tumor entities with hepatocellular carcinoma are excluded). |
• Macroscopically complete resection (R0/1) within 6 (−16) weeks before scheduled start of CTx. |
• Performance status according to the ECOG of 0–1. |
• Adequate hematologic function: ANC ≥1.5 × 109/L, platelets ≥100 × 109/L, hemoglobin ≥9 g/dl or ≥5.59 mmol/L. |
• Adequate liver function as measured by serum transaminases (AST and ALT) ≤5 x ULN and bilirubin ≤3 x ULN. |
• Adequate renal function, i.e. serum creatinine ≤1.5 x ULN, glomerular filtration rate ≥ 60 mL/min determined with the MDRD formula. |
• No active uncontrolled infection, except chronic viral hepatitis under antiviral therapy. |
• No concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomization. |
• Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women <1 year after the onset of menopause (a negative test has to be reconfirmed by a urine test, should the 7-day window be exceeded). |