Immuno-genomic-radiomics to predict response of biliary tract cancer to camrelizumab plus GEMOX in a single-arm phase II trial

Adeva, 2019, Medical treatment for cholangiocarcinoma, Liver Int, 39, 123, 10.1111/liv.14100 Scott, 2022, Precision medicine in biliary tract cancer, J Clin Oncol, 40, 2716, 10.1200/JCO.21.02576 Valle, 2021, Biliary tract cancer, Lancet, 397, 428, 10.1016/S0140-6736(21)00153-7 Oh, 2022, A phase 3 randomized, double-blind, placebo-controlled study of durvalumab in combination with gemcitabine plus cisplatin (GemCis) in patients (pts) with advanced biliary tract cancer (BTC): TOPAZ-1, J Clin Oncol, 40, 378, 10.1200/JCO.2022.40.4_suppl.378 Roth, 2023, Cholangiocarcinoma: what are the options in all comers and how has the advent of molecular profiling opened the way to personalised medicine?, Eur J Cancer, 179, 1, 10.1016/j.ejca.2022.11.006 Loeuillard, 2019, Immunobiology of cholangiocarcinoma, JHEP Rep, 1, 297, 10.1016/j.jhepr.2019.06.003 Bang, 2019, Pembrolizumab (pembro) for advanced biliary adenocarcinoma: results from the KEYNOTE-028 (KN028) and KEYNOTE-158 (KN158) basket studies, J Clin Oncol, 37, 4079, 10.1200/JCO.2019.37.15_suppl.4079 Carapeto, 2022, The immunogenomic landscape of resected intrahepatic cholangiocarcinoma, Hepatology, 75, 297, 10.1002/hep.32150 Sanmamed, 2018, A paradigm shift in cancer immunotherapy: from enhancement to normalization, Cell, 175, 313, 10.1016/j.cell.2018.09.035 Chen, 2019, Pretreatment prediction of immunoscore in hepatocellular cancer: a radiomics-based clinical model based on Gd-EOB-DTPA-enhanced MRI imaging, Eur Radiol, 29, 4177, 10.1007/s00330-018-5986-x Gillies, 2016, Radiomics: images are more than pictures, they are data, Radiology, 278, 563, 10.1148/radiol.2015151169 King, 2020, Outcomes assessment in intrahepatic cholangiocarcinoma using qualitative and quantitative imaging features, Cancer Imaging, 20, 43, 10.1186/s40644-020-00323-0 Yang, 2020, Radiomics model of magnetic resonance imaging for predicting pathological grading and lymph node metastases of extrahepatic cholangiocarcinoma, Cancer Lett, 470, 1, 10.1016/j.canlet.2019.11.036 Chen, 2020, Camrelizumab plus gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary tract cancer: a single-arm, open-label, phase II trial, J Immunother Cancer, 8 Chen, 2021, Genomic alterations in biliary tract cancer predict prognosis and immunotherapy outcomes, J Immunother Cancer, 9 Schwartz, 2016, RECIST 1.1-Update and clarification: from the RECIST committee, Eur J Cancer, 62, 132, 10.1016/j.ejca.2016.03.081 Tibshirani, 1997, The lasso method for variable selection in the Cox model, Stat Med, 16, 385, 10.1002/(SICI)1097-0258(19970228)16:4<385::AID-SIM380>3.0.CO;2-3 Liao, 2019, Preoperative radiomic approach to evaluate tumor-infiltrating CD8(+) T cells in hepatocellular carcinoma patients using contrast-enhanced computed tomography, Ann Surg Oncol, 26, 4537, 10.1245/s10434-019-07815-9 Zhang, 2020, Machine learning: an approach to preoperatively predict PD-1/PD-L1 expression and outcome in intrahepatic cholangiocarcinoma using MRI biomarkers, ESMO Open, 5, 10.1136/esmoopen-2020-000910 Lin, 2022, Biomarkers for response to immunotherapy in hepatobiliary malignancies, Hepatobiliary Pancreat Dis Int, 21, 413, 10.1016/j.hbpd.2022.08.002 Ji, 2019, Biliary tract cancer at CT: a radiomics-based model to predict lymph node metastasis and survival outcomes, Radiology, 290, 90, 10.1148/radiol.2018181408 Li, 2021, Role of noninvasive imaging in the evaluation of intrahepatic cholangiocarcinoma: from diagnosis and prognosis to treatment response, Expert Rev Gastroenterol Hepatol, 15, 1267, 10.1080/17474124.2021.1974294 Riley, 2020, Calculating the sample size required for developing a clinical prediction model, BMJ, 368, m441, 10.1136/bmj.m441 Riley, 2022, Minimum sample size calculations for external validation of a clinical prediction model with a time-to-event outcome, Stat Med, 41, 1280, 10.1002/sim.9275