{"entity":{"id":"nct05987358","kind":"trial","name":"A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma","aka":[],"tldr":"A phase 3 trial testing TQB3454 in biliary tract cancer, active and no longer recruiting.","summary":"A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma is a phase 3 interventional study registered as NCT05987358, led by Chia Tai Tianqing Pharmaceutical, and active but no longer recruiting on the registry. Official title: A Randomised, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of TQB3454 Tablets in the Treatment of Advanced Biliary Tract Cancer With Isocitrate Dehydrogenase 1 (IDH1) Mutation. Planned enrolment is 165 participants (estimated). The study started in 2023-09-21 and primary completion is expected in 2026-12. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05987358","url":"https://clinicaltrials.gov/study/NCT05987358"}],"tags":["ctgov-ingest"],"related":[],"cancers":["cholangiocarcinoma","intrahepatic-cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb3454"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05987358","phase":"3","setting":"A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of TQB3454 Tablets in the Treatment of Advanced Biliary Tract Cancer With Isocitrate Dehydrogenase 1 (IDH1) Mutation","sponsor":"Chia Tai Tianqing Pharmaceutical","started":"2023-09-21","startedType":"actual","enrolled":165,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05987358/","neighbours":{"cancer":[{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"id":"intrahepatic-cholangiocarcinoma","kind":"cancer","name":"Intrahepatic cholangiocarcinoma","route":"/cancers/intrahepatic-cholangiocarcinoma/"}],"drug":[{"id":"tqb3454","kind":"drug","name":"TQB3454","route":"/drugs/tqb3454/"}],"company":[{"id":"sino-biopharm","kind":"company","name":"Sino Biopharmaceutical (Chia Tai Tianqing)","route":"/companies/sino-biopharm/"}]}}