This research study is designed to establish whether the combination of IBI310 \& Sintilimab has efficacy in patients with advanced BTC
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
2mg/kg IV,3 weeks later, 1mg/kg IV Q6W
200mg IV Q3W
Hunan cancer Hospital
Changsha, Hunan, China
RECRUITINGObjective response rate (ORR)
Investigator evaluated ORR per RECIST V1.1
Time frame: up to 24 months
progression free survival, PFS
PFS is defined as the time from first treatment to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1), or death due to any cause.
Time frame: up to 24 months
duration of response, DoR
Defined as the time from the first documented objective response to the first documented progressive disease or death of any cause, whichever occurs first;
Time frame: up to 24 months
disease control rate, DCR
Defined as the proportion of patients whose best response is CR, PR, and stable disease (SD) non-CR/non-PD
Time frame: up to 24 months
Overall Survival,OS
OS is defined as the time from enrollment to the date of death.
Time frame: up to 24 months
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