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This is a combination therapy consisting of three agents: - **Recombinant oncolytic virus M1** (also known as M1-c6v1): A mutant variant of the alphavirus-based oncolytic virus that selectively infects and replicates in tumor cells, leading to direct tumor cell lysis and induction of immunogenic cell death. This process disrupts immune tolerance within the tumor microenvironment and promotes recruitment and activation of dendritic cells and CD8+ T cells, thereby enhancing antitumor immunity. The use of this agent has been shown to sensitize tumors to immune checkpoint blockade by upregulating PD-L1 expression[5][3][4][7]. - **Anti PD-1 antibody**: A monoclonal antibody targeting the programmed cell death protein 1 (PD-1) receptor on T cells. By blocking this inhibitory pathway, it enhances T-cell-mediated antitumor responses. - **Apatinib**: A small molecule tyrosine kinase inhibitor that selectively inhibits vascular endothelial growth factor receptor 2 (VEGFR2), thereby suppressing angiogenesis in tumors. The combination aims to synergistically enhance antitumor efficacy by directly lysing tumor cells (M1), reversing immunosuppression and boosting immune response (M1 + anti-PD-1), and inhibiting tumor angiogenesis (apatinib). Recombinant oncolytic virus M1 was initially developed by Guangzhou Virotech Pharmaceutical Co., Ltd., which is also listed as its sponsor for orphan drug designation for primary liver cancer[2][7].
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