Unresectable and Advanced Cholangiocarcinoma Clinical Trial
Official title:
A Phase II Open-label Single Arm Study of Sunitinib in Patients With Advanced Cholangiocarcinoma
For patients with non-resectable cholangiocarcinoma, gemcitabine with cisplatin is
considered as the reference treatment in first line chemotherapy. However, the outcomes of
these patients remain limited and therefore more effective drugs are warranted. The context
of the disease and current data on sunitinib suggest that sunitinib may have activity in
patients with advanced non resectable cholangiocarcinoma.
Thereby, it is proposed to conduct an open label single arm trial aiming evidencing activity
of sunitinib in such a patient population.
The primary objective is to evaluate the overall survival of patients with advanced and
unresectable cholangiocarcinoma treated continuously by sunitinib as second line at the dose
of 37.5 mg per day, after one line of chemotherapy and to determine whether sunitinib
deserves further studies in this indication.
The secondary objectives are
- To evaluate the criteria of efficacy
- To evaluate the effects of sunitinib on tumor angiogenesis
- To characterize the safety profile of sunitinib
- To identify markers associated with response to sunitinib
;