Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
2. Histologically confirmed intrahepatic cholangiocarcinoma that is unresectable or recurrent after curative treatment, without extrahepatic metastasis.
3. No prior systemic therapy or transarterial interventional therapy for intrahepatic cholangiocarcinoma.
4. At least one measurable intrahepatic lesion according to RECIST v1.1.
5. ECOG performance status of 0 or 1.
6. Child-Pugh class A liver function.
7. Life expectancy ≥3 months.
8. 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.
You may not be if
1. Diffuse infiltrative liver lesions.
2. Contraindications to TACE.
3. Allergy to intravenous contrast agent.
4. pregnant or breastfeeding women, or participants planning pregnancy within 2 years / unwilling to use effective contraception.
5. Patients with HIV or syphilis infection.
6. Patients with concurrent malignancies or other malignancies within 5 years before enrollment.
7. History of allogeneic organ transplantation.
8. Severe dysfunction of the heart, kidney, or other organs.
9. Severe clinically active infection \> grade 2 according to NCI-CTC v5.0.
10. 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.
Clareo Health | Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
