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GS + toripalimab is a combination chemo-immunotherapy regimen consisting of the PD-1 inhibitor toripalimab and the GS chemotherapy regimen (gemcitabine and S-1). This regimen is primarily investigated as a first-line treatment for patients with advanced biliary tract cancer (BTC), including gallbladder carcinoma and intrahepatic or extrahepatic cholangiocarcinoma. Toripalimab is a recombinant humanized IgG4 monoclonal antibody that targets the programmed cell death protein 1 (PD-1) receptor, blocking its interaction with PD-L1 and PD-L2 to restore anti-tumor T-cell activity. Gemcitabine is a nucleoside metabolic inhibitor, and S-1 is an oral fluoropyrimidine combination. Clinical data from a Phase II study at Shanghai Zhongshan Hospital (NCT03796429) showed that the combination provides a median progression-free survival of 7.0 months and a median overall survival of 15.0 months in treatment-naive patients.
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