A phase II study evaluating the efficacy of Selective Internal Radiation Therapy combined with Capecitabine in the neoadjuvant setting of Operable intrahepatic CHOlangiocarcinoma

Prior treatment

• Patient participate to an interventional study that tests another medical intervention before surgery
• Significant heart disease or history of heart rhythm disorders, myocardial infarction or angina pectoris in the 6 months prior to inclusion
• Previous chemotherapy (including for another cancer)
• Previous abdominal (supra-mesocolic) radiotherapy (including for another cancer)

Other illness

• Other invasive malignancies
• Respiratory insufficiency
• Contraindication to hepatic artery catheterization (vascular abnormalities, bleeding diathesis)

Lab values

• Inadequate haematological, hepatic, renal and coagulation functions: Haemoglobin ≤ 8,5 g/dl, Neutrophils < 1,5 Giga/L, Platelets < 60 Giga/L, Bilirubin > 34 µmol/L, ASAT/ALAT > 5 x ULN, Creatinine clearance < 30 ml/min (MDRD), TP et INR > 2,3 ULN, TCA > 1,5 x ULN

Other

• Severe fibrosis (F3) ou cirrhosis (F4)
• Pregnant woman or likely to be or breastfeeding, or male or female patients of reproductive potential without effective contraception from screening to 30 days after the end of the treatment adjuvant
• Minors, individual deprived of liberty, or under any kind of guardianship
• Patients unable to submit to medical follow-up of the study for social, medical or psychological reasons
• Uracil blood level >16 ng/mL
• Presence of microvacuolar steatosis > 60% or regenerative nodular hyperplasia, for patients for whom a major hepatectomy is planned

• Age > 18 years-old
• ECOG Performance Status <2
• Histologically-proven ICC
• No previous treatment for ICC
• Tumour deemed resectable by a hepatobiliary surgeon, validated by a Surgical Review Board
• Significant risk of close margins, defined as: Resection margin predicted by the surgeon <1cm or Tumour > 5cm or Multifocal lesion deemed resectable, validated by a Surgical Review Board
• Registration with a social security scheme
• Patient information and signature of informed consent or legal representative