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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Bortezomib Injectable Solution
Easter hepatobiliary surgery hospital
Shanghai, Shanghai Municipality, China
RECRUITINGObjective response rate
Objective response rate include response from stable disease to complete response based on RECIST 1.1
Time frame: at least 2 months
changes of platelet count
changes of platelet count after injection of Bortezomib
Time frame: 7 days
occurrence of peripheral neuritis
occurrence of any feeling of numbness of limbs
Time frame: 7 days
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