SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma

Inclusion Criteria

• •Willing, able and mentally competent to provide written informed consent.
• •Aged 18 years or older.
• •Histologically or cytologically confirmed unresectable and non-ablatable intrahepatic cholangiocarcinoma.
• •Liver-only or liver predominant intrahepatic cholangiocarcinoma. Patient are permitted to have loco-regional lymph node involvement defined as: portal LN \</= to 2 cm and/or para aortic LN \</= to 1.5 cm in longest diameter, and/or up to 2 indeterminate lung lesions \< 1 cm if these lung lesions are positron emission tomography (PET) negative.
• •Chemotherapy naïve. Adjuvant chemotherapy is not permitted.
• •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• •Adequate hematological function defined as:
• •Hemoglobin \>/= 10g/dL White Blood Cell count (WBC) \>/= 3.0 x 10\^9/L Absolute neutrophil count (ANC) \>/= 1.5 x 10\^9/L Platelet count \>/= 100,000/mm\^3 - Adequate liver function defined as: Total bilirubin \</= 30 umol/L (1.75 mg/dL) Albumin \>/= 30 g/L
• •\- Adequate renal function defined as: Serum urea and serum creatinine \< 1.5 times upper limit of normal (ULN) Creatinine clearance \>/= 45 ml/min (calculated with Cockcroft-Gault Equation)
• •Life expectancy of at least 3 months without any active treatment
• •Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active use an acceptable method of contraception during the study.
• •Male patients must be surgically sterile or if sexually active must use an acceptable method of contraception during the study.
• •Considered suitable to receive either regimen in the clinical judgement of the treating investigator.