Cholangiocarcinoma (Bile Duct Cancer) Clinical Trials

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US, European Union \[EU\] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.

• Histologically or pathologically confirmed CCA

• Age \>18 years at time of study entry.

• Eastern Cooperative Oncology Group (ECOG) 0 or 1.

• Locally advanced disease (as assessed in multidisciplinary sessions).

• Life expectancy of at least 16 weeks.

• Body weight \>30 kg

• Adequate normal organ and marrow function as defined below: Haemoglobin ≥9.0 g/dL

• Absolute neutrophil count (ANC ≥1.5 × 109 /L)

• Platelet count ≥100 × 109/L

• Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.

• AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN

• Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine clearance CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.

• At least 1 lesion that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to randomization.

• No previous systemic or local treatments including radiation therapy, radiofrequency ablations, electro-chemotherapy.