The goal of this clinical trial is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) combined with tislelizumab and regorafenib as first-line therapy in patients with locally advanced or metastatic cholangiocarcinoma. The main questions it aims to answer are: 1. What is the objective response rate (ORR) of this combination regimen according to RECIST 1.1 criteria 2. What are the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profile associated with this treatment Participants will:Receive hepatic arterial infusion chemotherapy (HAIC)+ tislelizumab (PD-1 inhibitor)+regorafenib (oral multikinase inhibitor). Undergo regular imaging assessments to evaluate tumor response per RECIST 1.1.Be monitored for survival outcomes and adverse events throughout treatment and follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
A combination therapy including hepatic arterial infusion chemotherapy (HAIC), tislelizumab, and regorafenib for first-line treatment of advanced cholangiocarcinoma.
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
objective response rate (ORR)
Time frame: From first dose until disease progression, death, or up to approximately 24 months
disease control rate (DCR)
Time frame: From first dose until disease progression or last tumor assessment, whichever occurs first (up to approximately 24 months)
Progression-Free Survival (PFS)
Time frame: From first dose to disease progression or death from any cause, whichever occurs first (up to approximately 24 months)
Overall Survival (OS)
Time frame: From first dose to death from any cause (up to approximately 36 months)
adverse events
Time frame: From first dose until 30 days after the last dose of study treatment
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