Cadonilimab Combined With Gem/Cis as First Line Therapy in Patients With Advanced ICC
Status:
Active, not recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
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.