Kantonsspital St.Gallen

SAKK 41/16: Neoadjuvant treatment with Regorafenib and Capecitabine combined with radiotherapy in locally advanced rectal ca cer. A multicenter phase Ib trial (RECAP)

Markus Joerger

abstract Despite treatment of locally advanced rectal cancer re-lapses are frequent. Several attempts to improve these results with therapy intensification have shown modest effect on disease free survival (DFS) and overall survival (OS). Recent studies with addition of sorafenib and cediranib revealed promising effect on tumor response with acceptable toxicity. Regorafenib is a multi tyrosine kinase inhibitor (TKI) with a broad mechanism of action. Therefore this trial investigates if similar results can be achieved as with sorafenib or cediranib. The objective of the dose esca-lation part is to determinate safety, tolerability and the rec-ommended dose. The objective of the expansion cohort is to assess the efficacy and to further characterize safety and tolerability of the therapy.
type of project clinical studies
status ongoing - recruiting phase
start of project 2017
end of project 2019
study design Phase 1b
responsible person PD Dr. med. Markus J├Ârger