Cholangiocarcinoma Clinical Trial
Official title:
REGORAFENIB AFTER FAILURE OF GEMCITABINE AND PLATINUM-BASED CHEMOTHERAPY FOR LOCALLY ADVANCED (NON RESECTABLE) AND METASTATIC INTRA-HEPATIC OR HILAR CHOLANGIOCARCINOMA: A Randomized Double-blinded Phase II Trial.
The study is a multicenter randomized (1:1) placebo-controlled, double-blinded phase II trial
aiming to demonstrate an improvement of median PFS when treating locally advanced
unresectable or metastatic patients suffering from an intra-hepatic or hilum (mass-forming)
cholangiocarcinoma with Regorafenib as compared to placebo, and after progression after
GEM-CDDP (or GEM-OX), or gemcitabine alone followed or preceded by platinum (CDDP or
oxaliplatin)-based chemotherapy.
The principal objective is to investigate Regorafenib efficacy by prospectively evaluating
the PFS after the administration of Regorafenib combined with BSC as compared to placebo with
BSC. Hypothesis is a 50% improvement in median PFS (from 6 weeks to 12 weeks in Regorafenib
group).
The principal objective is to investigate Regorafenib efficacy by prospectively evaluating the PFS after the administration of Regorafenib combined with BSC as compared to placebo with BSC. Hypothesis is a 50% improvement in median PFS (from 6 weeks to 12 weeks in Regorafenib group). ;
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