{"entity":{"id":"cares-310","kind":"trial","name":"CARES-310","aka":[],"tldr":"A PD-1 antibody plus an oral anti-VEGF pill beat sorafenib on survival, one of the largest benefits seen in liver cancer.","summary":"CARES-310, trial NCT03764293 sponsored by Jiangsu Hengrui and Elevar and reported in 2023, showed that the PD-1 antibody camrelizumab plus the oral anti-VEGF drug rivoceranib beat sorafenib on survival in first-line unresectable hepatocellular carcinoma, one of the largest benefits seen in the disease. It randomised 543 patients in a global trial with about eighty percent Asian enrolment, met both primary endpoints of overall and progression-free survival and produced a much higher response rate. OnCo links it to hepatocellular carcinoma, the camrelizumab plus rivoceranib record, rivoceranib, Jiangsu Hengrui and Shukui Qin. The combination is approved in China but has received three FDA complete response letters over manufacturing, so whether it reaches Western patients is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03764293","url":"https://clinicaltrials.gov/study/NCT03764293"},{"label":"FDA CRL coverage","url":"https://www.cancernetwork.com/view/fda-issues-second-camrelizumab-rivoceranib-crl-in-hepatocellular-carcinoma"}],"tags":[],"related":["src-cancer-network"],"cancers":["hcc"],"sections":[],"technologies":["antiangiogenic","checkpoint-inhibitor"],"targets":[],"drugs":["camrelizumab-rivoceranib"],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["qin-shukui"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03764293","phase":"3","setting":"First-line unresectable HCC: camrelizumab + rivoceranib vs sorafenib","sponsor":"Jiangsu Hengrui / Elevar","result":"OS 23.8 vs 15.2 months, HR 0.62.","started":"2019-06-10","startedType":"actual","yearReported":2023,"enrolled":543,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Camrelizumab + rivoceranib","n":272,"value":23.8},{"name":"Sorafenib","n":271,"value":15.2}],"hr":0.62,"source":"https://doi.org/10.1016/S0140-6736(23)00961-3"},{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Camrelizumab + rivoceranib","value":5.6},{"name":"Sorafenib","value":3.7}],"hr":0.52,"source":"https://doi.org/10.1016/S0140-6736(23)00961-3"}]},"route":"/trials/cares-310/","neighbours":{"collection":[{"id":"src-cancer-network","kind":"collection","name":"CancerNetwork (ONCOLOGY)","route":"/collections/src-cancer-network/"}],"cancer":[{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"camrelizumab-rivoceranib","kind":"drug","name":"Camrelizumab + rivoceranib","route":"/drugs/camrelizumab-rivoceranib/"},{"id":"rivoceranib","kind":"drug","name":"Rivoceranib (apatinib)","route":"/drugs/rivoceranib/"}],"company":[{"id":"hengrui","kind":"company","name":"Jiangsu Hengrui Pharmaceuticals","route":"/companies/hengrui/"}],"person":[{"id":"qin-shukui","kind":"person","name":"Shukui Qin","route":"/people/qin-shukui/"}]}}