{"entity":{"id":"reflect","kind":"trial","name":"REFLECT","aka":[],"tldr":"Lenvatinib matched sorafenib on survival with more tumour shrinkage, giving a second first-line option after a decade.","summary":"REFLECT, trial NCT01761266 sponsored by Eisai and reported in 2018, showed that lenvatinib matched sorafenib on survival with more tumour shrinkage, giving first-line unresectable hepatocellular carcinoma a second option after a decade. It randomised 954 patients in a non-inferiority design, met its primary overall survival endpoint for non-inferiority, and improved progression-free survival and response rate by modified RECIST, making it the first positive first-line trial since SHARP. OnCo links it to hepatocellular carcinoma, lenvatinib, sorafenib, Ann-Lii Cheng and Masatoshi Kudo. Because it showed equivalence rather than superiority, whether lenvatinib's higher response rate matters clinically, particularly before local therapies, remains the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01761266","url":"https://clinicaltrials.gov/study/NCT01761266"}],"tags":[],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["lenvatinib","sorafenib"],"companies":["eisai"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ann-lii-cheng","masatoshi-kudo"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01761266","phase":"3","setting":"First-line unresectable HCC: lenvatinib vs sorafenib (non-inferiority)","sponsor":"Eisai","result":"OS 13.6 vs 12.3 months, non-inferior (HR 0.92).","started":"2013-03-01","startedType":"actual","yearReported":2018,"enrolled":954,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Lenvatinib","n":478,"value":13.6},{"name":"Sorafenib","n":476,"value":12.3}],"hr":0.92,"ci":[0.79,1.06],"source":"https://doi.org/10.1016/S0140-6736(18)30207-1"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Lenvatinib","value":7.4},{"name":"Sorafenib","value":3.7}],"hr":0.66,"source":"https://doi.org/10.1016/S0140-6736(18)30207-1"}]},"route":"/trials/reflect/","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":"lenvatinib","kind":"drug","name":"Lenvatinib","route":"/drugs/lenvatinib/"},{"id":"sorafenib","kind":"drug","name":"Sorafenib","route":"/drugs/sorafenib/"}],"company":[{"id":"eisai","kind":"company","name":"Eisai","route":"/companies/eisai/"}],"person":[{"id":"ann-lii-cheng","kind":"person","name":"Ann-Lii Cheng","route":"/people/ann-lii-cheng/"},{"id":"masatoshi-kudo","kind":"person","name":"Masatoshi Kudo","route":"/people/masatoshi-kudo/"}],"paper":[{"id":"paper-reflect-lenvatinib-lancet-2018","kind":"paper","name":"REFLECT: lenvatinib versus sorafenib in first-line treatment of unresectable hepatocellular carcinoma","route":"/key-papers/paper-reflect-lenvatinib-lancet-2018/"}]}}