Introduction
cancers, death, heterogeneous hepatobiliary malignant tumor, lung cancer, Biliary tract cancer, Hodgkin lymphoma, tumors, cholangiocarcinoma
CANCERS, MALIGNANT MELANOMA, RENAL CARCINOMA, LUNG CANCER, HODGKIN LYMPHOMA, HEPATOCELLULAR CARCINOMA, TUMORS, CHOLANGIOCARCINOMA
Biliary tract cancer (BTC) is a heterogeneous hepatobiliary malignant tumor, comprising cholangiocarcinoma (tumors originating from the intrahepatic, perihilar, or distal biliary tree) and gallbladder carcinomaThe ABC-02 study is the landmark study to establish gemcitabine and cisplatin (GemCis) as the standard first-line therapy for BTC, based on its superior overall survival benefits [11.7 vs. 8.1 months; hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.52–0.80, Immune checkpoint inhibitors (ICIs) have shown clinical benefits in various cancers, such as lung cancer, malignant melanoma, and renal carcinoma. The antitumor activity of anti-programmed cell death 1/ligand 1 (PD-1/PD-L1) antibodies monotherapy in BTC has been investigated, including pembrolizumab and nivolumab in patients with BTC. However, the efficacy is relatively modest (objective response rates (ORRs) range from 3–22%)Currently, favorable biomarkers are lacking for the immunotherapy of BTC. There is no definitive evidence that positive PD-L1 expressionIn this work, we conduct this prospective trial to evaluate the efficacy and safety of sintilimab, a selective anti-PD-1 antibody approved by the national medical products administration of China for treating Hodgkin lymphoma and hepatocellular carcinoma, in combination with GemCis for advanced BTCs. We also investigate the potential predictive biomarkers of clinical response.