A randomized controlled, phase II clinical trial is designed to compare the safety and efficacy of Sintilimab combined with GEMOX ± IBI305 and GEMOX as first-line therapy in advanced intrahepatic cholangiocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
200mg IV d1 Q3W
7.5mg/kg IV d1 Q3W
Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGOverall response rate ( ORR)
Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR
Time frame: up to 90 days after last treatment administration
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR、PR or SD
Time frame: up to 90 days after last treatment administration
Progression free survival (PFS)
the time period from randomization of the participants to objective tumor progression or death
Time frame: up to 3 years
Overall survival (OS)
the time period from the randomization of the participants to the death event due to any reason
Time frame: up to 3 years
Adverse event
All grades of adverse events, all grades of treatment related adverse events, serious of adverse events
Time frame: up to 30 days after last treatment administration
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