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Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Tislelizumab and Regorafenib as First-Line Therapy for Advanced Cholangiocarcinoma
Sponsor: The First Affiliated Hospital of Zhengzhou University
Summary
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.
Official title: Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Tislelizumab and Regorafenib as First-Line Therapy for Advanced Cholangiocarcinoma: A Single-Centre, Single-Arm, Phase II Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2022-07-22
Completion Date
2025-09-30
Last Updated
2026-06-02
Healthy Volunteers
No
Conditions
Interventions
HAIC Combined with Tislelizumab and Regorafenib
A combination therapy including hepatic arterial infusion chemotherapy (HAIC), tislelizumab, and regorafenib for first-line treatment of advanced cholangiocarcinoma.
Locations (1)
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China