WebThe trial was designed to have 80% power to detect an increase in median survival from 8 months in patients receiving gemcitabine alone to 11 … Web1. sep 2024 · By CCF Clinical Trials September 1, 2024 Study Name Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) (TOPAZ-1) ClinicalTrials.gov Identifier (if applicable) NCT03875235 Clinical Trial Category (check all that apply) First Line Therapy Chemotherapy …
TOPAZ-1 Overall Survival Prolonged With First-Line …
Web30. sep 2024 · Patients with advanced cholangiocarcinoma and an isocitrate dehydrogenase 1 (IDH1) mutation showed clinical benefit and improved progression-free survival (PFS) … Web18. jan 2024 · “TOPAZ-1 is the first phase III trial to show that adding immunotherapy to standard chemotherapy can increase survival in biliary tract cancer and, importantly, does … mary\u0027s corner retreat
New standard of care for advanced/metastatic biliary tract cancer
WebTopaz-1 was the first phase-III study demonstrating efficacy for the PD-L1 inhibitor durvalumab (D) in combination with gemcitabine (Gem) and cisplatin (Cis), and the combination has the potential to become a new first-line standard of care in biliary tract cancers (BTCs). WebIn addition to CT and MRI imaging, magnetic resonance cholangio-pancreatography (MRCP) allows for non-invasive evaluation of the biliary tree, tumor spread, ... the TOPAZ-1 study is a phase 3 trial testing the combination of gemcitabine/cisplatin with or without durvalumab, an anti-PD-L1 monoclonal antibody [NCT03875235]. 74 ... WebAdvanced BTC is a rare, heterogenous cancer with poor prognosis. At the preplanned interim analysis (data cutoff 11 August 2024) of TOPAZ-1 (NCT03875235), D + GC significantly improved OS versus PBO + GC in pts with advanced BTC (hazard ratio [HR], 0.80; 95% confidence interval [CI], 0.66–0.97; p=0.021). mary\\u0027s corsetiere plainview