Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT01718327
Brief Summary:
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.
Detailed Description:
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
Study:
NCT01718327
Study Brief:
Protocol Section:
NCT01718327