This is an open-label, single-arm, multicenter phase II clinical study to preliminarily observe and evaluate the efficacy and safety of Toripalimab combined with TACE in the treatment of extrahepatic cholangiocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Toripalimab, 240mg, IV infusion, every 3 weeks (q3w), combined withTACE (Gemcitabine 1000mg/m2 , Oxaliplatin 135mg/m2) in a cycle of 3 weeks(q3w).
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Hennan, China
RECRUITINGProgression-free survival
PFS is defined as time from the start of treatment to progression of disease or death.
Time frame: Up to 1 year
Objective response rate
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
Time frame: Up to 1 year
Disease control rate
The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.
Time frame: Up to 1 year
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