{"entity":{"id":"sharp","kind":"trial","name":"SHARP","aka":[],"tldr":"SHARP was the 2008 trial that gave liver cancer its first life-extending drug.","summary":"SHARP, trial NCT00105443 sponsored by Bayer and reported in 2008, was the trial that gave liver cancer its first life-extending drug, sorafenib. It randomised 602 patients with advanced hepatocellular carcinoma and preserved liver function to sorafenib or placebo, met its primary overall survival endpoint and delayed radiological progression, while the response rate was only about two percent, establishing that disease stabilisation rather than shrinkage drives benefit with anti-angiogenic drugs. OnCo links it to hepatocellular carcinoma, sorafenib and Josep M. Llovet, and the result was confirmed by the parallel Asia-Pacific trial and a decade of real-world use as the control arm of later trials. Whether any of the many drugs that failed to beat sorafenib were undone by the trial design rather than by biology is the question its long reign left behind.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00105443","url":"https://clinicaltrials.gov/study/NCT00105443"}],"tags":[],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["sorafenib"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["josep-llovet"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00105443","phase":"3","setting":"Advanced HCC, Child-Pugh A, no prior systemic therapy: sorafenib vs placebo","sponsor":"Bayer","result":"OS 10.7 vs 7.9 months, HR 0.69.","started":"2005-03","yearReported":2008,"enrolled":602,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Sorafenib","n":299,"value":10.7},{"name":"Placebo","n":303,"value":7.9}],"hr":0.69,"ci":[0.55,0.87],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa0708857"},{"endpoint":"Time to radiologic progression","unit":"months","arms":[{"name":"Sorafenib","value":5.5},{"name":"Placebo","value":2.8}],"hr":0.58,"source":"https://doi.org/10.1056/NEJMoa0708857"}],"replication":"Confirmed by the parallel Asia-Pacific trial (Cheng 2009) and a decade of real-world use."},"route":"/trials/sharp/","neighbours":{"cancer":[{"id":"hcc-advanced","kind":"cancer","name":"Advanced hepatocellular carcinoma (BCLC C)","route":"/cancers/hcc-advanced/"},{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"sorafenib","kind":"drug","name":"Sorafenib","route":"/drugs/sorafenib/"}],"company":[{"id":"bayer","kind":"company","name":"Bayer","route":"/companies/bayer/"}],"person":[{"id":"josep-llovet","kind":"person","name":"Josep M. Llovet","route":"/people/josep-llovet/"}],"paper":[{"id":"paper-sharp-sorafenib-nejm-2008","kind":"paper","name":"SHARP: sorafenib in advanced hepatocellular carcinoma","route":"/key-papers/paper-sharp-sorafenib-nejm-2008/"}]}}