This study was to evaluate the efficacy and safety of SHR-A1811 in patients with locally advanced unresectable or recurrent metastatic BTC with HER2 expression / amplification who failed first-line or second-line systemic treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
SHR-A1811
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGORR evaluated by IRC according to RECIST v1.1 standard
Time frame: About a year
DoR evaluated by IRC according to RECIST v1.1 standard
Time frame: About a year
DCR evaluated by IRC according to RECIST v1.1 standard
Time frame: About a year
PFS evaluated by IRC according to RECIST v1.1 standard
Time frame: About a year
ORR evaluated by the researchers according to the RECIST v1.1 standard
Time frame: About a year
DCR evaluated by the researchers according to the RECIST v1.1 standard
Time frame: About a year
DoR evaluated by the researchers according to the RECIST v1.1 standard
Time frame: About a year
PFS evaluated by the researchers according to the RECIST v1.1 standard
Time frame: About a year
OS
Time frame: About two year
AE
Time frame: About a year
SAE
Time frame: About a year
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