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This investigational combination therapy is a neoadjuvant regimen being evaluated for the treatment of resectable or borderline-resectable biliary tract cancer. It consists of two immune checkpoint inhibitors, tuvonralimab and iparomlimab, combined with the standard GEMOX chemotherapy backbone (gemcitabine and oxaliplatin). Tuvonralimab is a monoclonal antibody targeting cytotoxic T-lymphocyte protein 4 (CTLA-4), while iparomlimab is a monoclonal antibody targeting programmed cell death protein 1 (PD-1). These biologics, developed by Qilu Pharmaceutical, are often administered as a single bifunctional product (QL1706). The regimen aims to enhance the immune response against tumor cells while utilizing the cytotoxic effects of gemcitabine (a nucleoside analog) and oxaliplatin (a platinum-based agent) to improve surgical outcomes such as R0 resection rates and pathologic complete response.
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