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The combination of envafolimab (Enweida), lenvatinib, and capecitabine is an investigational oncology regimen being evaluated for the treatment of advanced solid tumors, particularly biliary tract cancer (BTC) and gallbladder cancer. Envafolimab is a subcutaneously administered single-domain antibody targeting programmed death-ligand 1 (PD-L1), which blocks the PD-1/PD-L1 pathway to restore T-cell-mediated anti-tumor immune responses. Lenvatinib is an oral, multi-targeted tyrosine kinase inhibitor (TKI) that selectively inhibits vascular endothelial growth factor receptors (VEGFR1-3), fibroblast growth factor receptors (FGFR1-4), platelet-derived growth factor receptor alpha (PDGFRα), and the RET and KIT proto-oncogenes, thereby exerting potent anti-angiogenic and direct anti-tumor effects. Capecitabine is an oral fluoropyrimidine carbamate prodrug that is enzymatically converted to 5-fluorouracil (5-FU) within tumor tissues, where it inhibits thymidylate synthase and interferes with DNA synthesis. This triplet regimen combines immune checkpoint inhibition, anti-angiogenesis, and cytotoxic chemotherapy to achieve synergistic anti-tumor activity. It is currently being investigated in Phase II clinical trials as a postoperative adjuvant therapy for resected biliary tract cancer with high-risk recurrence factors and as a first-line therapy for elderly patients with unresectable or metastatic gallbladder cancer.
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