Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:04 PM
Study NCT ID:
NCT03345303
Status:
UNKNOWN
Last Update Posted:
2017-11-17
First Post:
2017-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bortezomib in Intrahepatic Cholangiocellular Carcinoma
Sponsor:
Zhengang Yuan
Organization:
Study Overview
Official Title:
Bortezomib in Treating Patients With Intrahepatic Cholangiocellular Carcinoma Featuring PTEN Deficiency
Status:
UNKNOWN
Status Verified Date:
2017-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates the efficacy and safety of second-line treatment of bortezomib in advanced intrahepatic cholangiocarcinoma patients.Half of participants will receive bortezomib while the other half will receive best supporting care.
Detailed Description:
There's no standard second-line treatment for advanced intrahepatic cholangiocarcinoma patients.
Previous study indicated high mutation/deletion rate of PTEN gene in intrahepatic cholangiocarcinoma and poor prognosis of those patients with PTEN mutation/deletion. The investigators also found that the activity of proteasomes elevated in cholangiocarcinoma cells with PTEN mutation/deletion.
So the investigators suppose proteasomes inhibitor could improve prognosis of intrahepatic cholangiocarcinoma patients with PTEN mutation/deletion
Previous study indicated high mutation/deletion rate of PTEN gene in intrahepatic cholangiocarcinoma and poor prognosis of those patients with PTEN mutation/deletion. The investigators also found that the activity of proteasomes elevated in cholangiocarcinoma cells with PTEN mutation/deletion.
So the investigators suppose proteasomes inhibitor could improve prognosis of intrahepatic cholangiocarcinoma patients with PTEN mutation/deletion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: