{"entity":{"id":"zgdh3","kind":"trial","name":"ZGDH3 (donafenib vs sorafenib)","aka":[],"tldr":"The first trial in which a new pill beat sorafenib on survival in liver cancer, with a Chinese deuterated redesign of sorafenib itself.","summary":"668 patients, open label. Median overall survival 12.1 versus 10.3 months (hazard ratio 0.83) with fewer grade 3 or higher adverse events; published in the Journal of Clinical Oncology 2021. NMPA approval June 2021. A small gain, but the first head-to-head overall survival win against sorafenib and an example of incremental medicinal chemistry rewarded in China's market.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT02645981","url":"https://clinicaltrials.gov/study/NCT02645981"},{"label":"J Clin Oncol 2021","url":"https://doi.org/10.1200/JCO.20.02672"}],"tags":["china"],"related":[],"cancers":["hcc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["donafenib","sorafenib"],"companies":["zelgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["qin-shukui"],"bottlenecks":[],"keyPapers":["paper-gordan-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02645981","phase":"2/3","setting":"First-line unresectable or metastatic hepatocellular carcinoma, China: donafenib vs sorafenib","sponsor":"Suzhou Zelgen Biopharmaceuticals","result":"OS 12.1 vs 10.3 months, HR 0.83.","started":"2016-03","yearReported":2021,"enrolled":668,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Donafenib","n":334,"value":12.1},{"name":"Sorafenib","n":334,"value":10.3}],"hr":0.83,"source":"https://doi.org/10.1200/JCO.20.02672"}]},"route":"/trials/zgdh3/","neighbours":{"cancer":[{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"donafenib","kind":"drug","name":"Donafenib","route":"/drugs/donafenib/"},{"id":"sorafenib","kind":"drug","name":"Sorafenib","route":"/drugs/sorafenib/"}],"company":[{"id":"zelgen","kind":"company","name":"Suzhou Zelgen Biopharmaceuticals","route":"/companies/zelgen/"}],"person":[{"id":"qin-shukui","kind":"person","name":"Shukui Qin","route":"/people/qin-shukui/"}],"paper":[{"id":"paper-gordan-j-clin-oncol","kind":"paper","name":"Systemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline","route":"/key-papers/paper-gordan-j-clin-oncol/"}]}}