The stratification factors to be used at randomization include stage (locally advanced vs. metastatic), anatomic subsite of primary tumor (intrahepatic cholangiocarcinoma vs. other, i.e. extrahepatic cholangiocarcinoma, gallbladder, or ampullary), and Eastern Cooperative Oncology Group (ECOG) Performance ...
The prospective, multicenter, open-label, Simon Two-Stage adaptive design trial was launched to examine the use of CTX-009 plus paclitaxel for the treatment of patients with advanced, unresectable, metastatic or recurrent biliary tract cancer who had an ECOG performance status of ...
Biliary tract cancer subtypes included intrahepatic cholangiocarcinoma (n = 9), extrahepatic cholangiocarcinoma (n = 3), gallbladder cancer (n = 7), and ampullary carcinoma (n = 5). Additional data showed that patients experienced an overall median PFS of 9.4 months (95% CI, 5.4-11.1). The...