Advanced Chemorefractory Colorectal Adenocarcinoma Clinical Trial
Official title:
Regorafenib Assessment in Refractory Advanced Colorectal Cancer
The general objectives are to evaluate activity and the safety of regorafenib in a population of patients bearing advanced, refractory colorectal cancers and to explore the different downstream molecular pathways to identify tumor response and resistance mechanisms.
The primary objective is to identify in a population of patients bearing advanced, refractory
colorectal cancers, those who draw no benefit from treatment with regorafenib. There is no
specific hypothesis underlying sample size and the study is therefore to be seen as
exploratory.
Secondary objectives:
- To analyze PFS and response rate (RR) in relationship with the same covariates as for OS
- To assess regorafenib efficacy (OS, PFS, RR) and safety profile in this study
population.
- To assess the Disease control rate (DCR = Complete response [CR] + partial response [PR]
+ stable disease [SD])
- To compare the relative benefit (OS, PFS) of regorafenib according to history of
treatment with bevacizumab.
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