Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Tislelizumab and Regorafenib as First-Line Therapy for Advanced Cholangiocarcinoma

Inclusion criteria

• Age 18-75 years ;
• Histologically or cytologically confirmed unresectable locally advanced or metastatic intra- or extrahepatic cholangiocarcinoma ;
• Clinical stage III-IV according to the 8th edition of the AJCC TNM classification ;
• No prior antitumor therapy;
• Child-Pugh liver function class A or B ;
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
• At least one measurable lesion per RECIST 1.1 ;
• Adequate haematologic and hepatic/renal function;
• Total bilirubin ≤ 2× upper limit of normal (patients who have undergone biliary drainage are eligible) ;
• Adequate cardiac and pulmonary reserves to tolerate interventional procedures ;
• Signed informed consent, good compliance, and ability to attend follow-up visits.

Exclusion criteria

• Contraindications to transarterial chemoembolization, targeted therapy, or immunotherapy ;
• Prior antitumor treatment ;
• Concurrent primary malignancies;
• Child-Pugh class C;
• Severe cardiac, pulmonary, or renal dysfunction ;
• Active autoimmune disease or need for long-term immunosuppressive therapy ;
• Hypersensitivity to contrast agents or study drugs ;
• Pregnancy or lactation;
• Anticoagulant or thrombolytic therapy within 3 months before enrollment or bleeding diathesis.