Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma

Inclusion criteria

• Age ≥18 years.
• Histologically confirmed intrahepatic cholangiocarcinoma that is unresectable or recurrent after curative treatment, without extrahepatic metastasis.
• No prior systemic therapy or transarterial interventional therapy for intrahepatic cholangiocarcinoma.
• At least one measurable intrahepatic lesion according to RECIST v1.1.
• ECOG performance status of 0 or 1.
• Child-Pugh class A liver function.
• Life expectancy ≥3 months.
• Adequate hematologic, hepatic, renal, and thyroid function within 14 days before study start, defined as:

• Absolute neutrophil count ≥1.5 × 10⁹/L;
• Platelet count ≥75 × 10⁹/L;
• Hemoglobin ≥90 g/L;
• Serum albumin ≥30 g/L;
• Total bilirubin ≤1.5 × upper limit of normal;
• AST and ALT <1.5 × upper limit of normal, and ALP <4 × upper limit of normal;
• TSH <1 × upper limit of normal, with T3 and T4 within the normal range;
• Serum creatinine <1.5 × upper limit of normal and creatinine clearance ≥60 mL/min.

Exclusion criteria

• Diffuse infiltrative liver lesions.
• Contraindications to TACE.
• Allergy to intravenous contrast agent.
• pregnant or breastfeeding women, or participants planning pregnancy within 2 years / unwilling to use effective contraception.
• Patients with HIV or syphilis infection.
• Patients with concurrent malignancies or other malignancies within 5 years before enrollment.
• History of allogeneic organ transplantation.
• Severe dysfunction of the heart, kidney, or other organs.
• Severe clinically active infection > grade 2 according to NCI-CTC v5.0.
• Psychiatric illness that may affect the informed consent process; Inability to take oral medications; Participation in another drug clinical trial within 12 months before enrollment.