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This combination regimen consists of envafolimab, a subcutaneous PD-L1 single-domain antibody, lenvatinib, an oral multi-kinase inhibitor, and the chemotherapy doublet gemcitabine and cisplatin. It is being evaluated as a first-line treatment for patients with advanced biliary tract cancer (BTC). Envafolimab blocks the interaction between PD-L1 and PD-1, enhancing T-cell anti-tumor activity. Lenvatinib inhibits multiple receptor tyrosine kinases involved in angiogenesis and tumor proliferation, including VEGFR and FGFR. Gemcitabine and cisplatin provide cytotoxic effects by interfering with DNA synthesis and repair. The regimen is currently being studied in the Phase 2 ENLIGHTEN trial (NCT05410197) led by Sun Yat-sen University.
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