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Irinotecan liposome + 5-FU/LV + lenvatinib + tislelizumab is a multi-agent combination regimen under clinical investigation for the first-line treatment of unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma (ICC). The regimen combines regional and systemic therapies: hepatic arterial infusion chemotherapy (HAIC) using liposomal irinotecan (a topoisomerase I inhibitor), 5-fluorouracil (an antimetabolite), and leucovorin (a biochemical modulator); oral lenvatinib (a multi-target receptor tyrosine kinase inhibitor targeting VEGFR, FGFR, PDGFR, RET, and KIT); and tislelizumab (a PD-1 immune checkpoint inhibitor). This approach aims to maximize local tumor control in the liver while providing systemic anti-angiogenic and immunotherapeutic effects. The regimen is currently being evaluated in a Phase 2 trial (NCT07646717) sponsored by Tianjin Medical University Cancer Institute and Hospital.
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