TOPAZ-1 phase III trail demonstrated that the addition of immune checkpoint inhibitor anti-PD-L1 antibody improved progression-free survival (PFS) and overall survival (OS) compared to Gem/Cis alone. Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. The goal of this clinical trial is to evaluated the efficacy and safety of cadonilimab combined with gemcitabine and cisplatin as first Line therapy in patients with advanced intrahepatic cholangiocarcinoma. Eligible participants will receive cadonilimab (up to 12 months) plus gemcitabine and cisplatin (for maximum of 6-8 cycles) until radiologic disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurred first. The primary endpoint is objective response rate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Cadonilimab (500mg, iv, Q3W, Day1) with gemcitabine(1000mg/m\^2, iv, Q3W, Day1and Day8) plus cisplatin(25mg/m\^2, iv, Q3W, Day1and Day8) up to 8 cycles followed by cadonilimab (500mg, iv, Q3W, Day1) plus capecitabine(1000 mg/m\^2 orally according to Body Surface Area (BSA),BID,Q3W,on Days 1-14)as maintenance therapy until disease progression or other discontinuation criteria, up to 24months.
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, China
Objective response rate (ORR) per RECIST 1.1
Defined as patients achieving a complete response \[CR\] or partial response \[PR\]
Time frame: Up to two years
Progression free survival (PFS) per RECIST 1.1
Defined as the time from the start of treatment to the date of progressive disease, or death, whichever occurred first.
Time frame: Up to two years
Desease control rate (DCR) per RECIST 1.1
CR + PR + SD
Time frame: Up to two years
Overall survival (OS)
Defined as the time from the start of treatment to the date of death from any cause
Time frame: Up to two years
6mo PFS rate per RECIST 1.1
Progression-free survival (PFS) rate at 6 months
Time frame: at 6 months
adverse events
Include Treatment emerge adverse events, treatment related adverse events and serious adverse events
Time frame: Up to two years
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