Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT01692704
Eligibility Criteria:
Inclusion criteria:
* Histologically or cytologically proven cholangiocellular carcinoma including gallbladder cancer.
* 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
* 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.
Exclusion criteria:
* 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.
* Treatment in clinical trial within 30 days prior to trial entry.
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01692704
Study Brief:
Protocol Section:
NCT01692704