The clinical trial is designed to evaluate the safety and efficacy of GEMOX combined with targeted therapy and immunotherapy for patients with advanced cholangiocarcinoma, and screen the potential biomarkers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
146
Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W
8/12mg PO QD continuously
240mg IV d1 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
The frequency, duration, and severity of adverse events
Safety is assessed by the frequency, duration, and severity of adverse events
Time frame: up to 30 days after last treatment administration
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