Methods/study design
gall bladder carcinoma
METASTATIC CHOLANGIOCARCINOMA, GALL BLADDER CARCINOMA
TRITICC is an interventional, prospective, open-label, non-randomised, exploratory, multicentre, single-arm phase IIA clinical trial organized and sponsored by the University of Dusseldorf. Eligible patients with histologically or cytologically confirmed, non-resectable, locally advanced or metastatic cholangiocarcinoma or gall bladder carcinoma will receive a second line combination chemotherapy with FTD/TPI and irinotecan in cycles of 14 days. In total 28 patients (including 3 calculated dropouts and invalid cases) after failure of a gemcitabine based first-line therapy will be enrolled at up to 6 centers. Screening is expected to be necessary in 40 patients.