{"entity":{"id":"nct04194775","kind":"trial","name":"A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma","aka":[],"tldr":"A phase 3 trial of Lenvatinib in hepatocellular carcinoma, run by CStone Pharmaceuticals, active and no longer recruiting.","summary":"A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma is a phase 3 interventional study registered as NCT04194775 by CStone Pharmaceuticals, with 534 participants enrolled, started 2019-12-13 and due to reach its primary completion in 2025-06-18. Interventions recorded: Nofazinlimab (CS1003)+Lenvatinib, Nofazinlimab (CS1003) Placebo+Lenvatinib. Conditions listed: Hepatocellular Carcinoma. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04194775","url":"https://clinicaltrials.gov/study/NCT04194775"}],"tags":["ctgov-ingest"],"related":[],"cancers":["hcc","hcc-advanced"],"sections":[],"technologies":["antiangiogenic","kinase-inhibitors"],"targets":[],"drugs":["lenvatinib"],"companies":["cstone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04194775","phase":"3","setting":"A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of Nofazinlimab (CS1003) in Combination With Lenvatinib Compared to Placebo in Combination With Lenvatinib as First-Line Therapy in Subjects With Advanced Hepatocellular Carcinoma (HCC)","sponsor":"CStone Pharmaceuticals","started":"2019-12-13","startedType":"actual","yearReported":2026,"enrolled":534,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Nofazinlimab + Lenvatinib","n":353,"value":21.6,"note":"95% CI 18.6 to 24.6; Figures from the ClinicalTrials.gov results section (first posted 2026-07-30), not from a publication"},{"name":"Placebo + Lenvatinib","n":181,"value":18.5,"note":"95% CI 14.7 to 21.8"}],"source":"https://clinicaltrials.gov/study/NCT04194775?tab=results"}]},"route":"/trials/nct04194775/","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/"}],"company":[{"id":"cstone","kind":"company","name":"CStone Pharmaceuticals","route":"/companies/cstone/"}]}}