Downstaging of Unresectable Intrahepatic or Hilar Cholangiocellular Carcinoma by Selective Intra-arterial Floxuridine and Systemic Cisplatin and Gemcitabine. A Dose Finding Single Center Phase IIa Study
- Histologically or cytologically proven cholangiocellular carcinoma.
- Non-resectable cholangiocellular carcinoma as judged within an interdisciplinary
tumor-board including senior hepatobiliary surgeons. Non- resectability is based on
insufficient remnant liver volume.
- Patient is not a candidate for liver transplantation
- WHO Performance Score 0 or 1
- No extrahepatic tumor, as evaluated by PET/CT scan of the chest and the
abdomen/pelvis with the exception of potentially resectable small lung nodules or
hilar lymph node involvement.
- The assessment is done within 21 days before registration.
- Adequate liver function or kidney function tests, including any of the following:
- Bilirubin < 2 x ULN
- Aspartate-Aminotransferase (AST) < 5 x ULN
- Alanine-Aminotransferase (ALT) < 5 x ULN
- Alkaline phosphatase < 5 x ULN
- Estimated creatinine clearance > 60 ml/min (using the Cockcroft formula)
- Adequate hematological values:
- Hemoglobin > 80 G/L
- Leucocytes > 3.00 G/L,
- Neutrophils > 1.00 G/Ll
- Platelets > 100 G/L
- Adequate coagulation parameter: Quick > 40%
- Signed written informed consent
- Patient age >/= 18 years
- Presentation of the case at the interdisciplinary tumor-board attended by
hepatobiliary surgeons, oncologists, hepatologists and radiologists
- Women who are not breastfeeding and are using effective contraception if sexually
active, who are not pregnant and agree not to become pregnant during the 12 months
thereafter. A negative pregnancy test before inclusion into the trial is required for
women < 50 years.
- Men who agree not to father a child during participation in the trial or during the
12 months thereafter.
- Patient compliance and geographic proximity allow proper staging and follow- up.
- Anatomic variant in arteriogram which prevents selective delivery of the chemotherapy
to the liver
- Life expectancy < 3 months
- Severe medical or psychiatric co-morbidity prohibiting the planned treatment or the
giving of informed consent
- Any man or woman of childbearing age in case of inadequate contraception
- Pregnancy or breastfeeding woman
- Known hypersensitivity to trial drugs or hypersensitivity to any other component of
the trial drugs.
- Past or current use of other anti-cancer therapy
- Treatment in clinical trial within 30 days prior to trial entry.
- Oral anticoagulation and/or Quick = 40%
- Active heart disease defined as congestive heart failure > NYHA class 2
- Past or current history (within the last 2 years prior to treatment start) of other
malignancies except basal and squamous cell carcinoma of the skin or in situ
carcinoma of the cervix
- Inability or unwillingness to comply with the study protocol