{"entity":{"id":"orient-32","kind":"trial","name":"ORIENT-32","aka":[],"tldr":"A Chinese trial showing that a PD-1 antibody plus a bevacizumab copy extends life in liver cancer, mirroring the global IMbrave150 result in a hepatitis B population.","summary":"571 patients randomised 2:1. Overall survival hazard ratio 0.57 (median not reached versus 10.4 months) and progression-free survival hazard ratio 0.56 at the first interim analysis; about 94% of patients had hepatitis B, the cause of most Chinese liver cancer. NMPA approval June 2021. With IMbrave150 it established anti-PD-(L)1 plus anti-VEGF as the first-line standard and gave China a reimbursed domestic option.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03794440","url":"https://clinicaltrials.gov/study/NCT03794440"},{"label":"Lancet Oncol 2021","url":"https://doi.org/10.1016/S1470-2045(21)00252-7"}],"tags":["china"],"related":[],"cancers":["hcc"],"sections":[],"technologies":["checkpoint-inhibitor","antiangiogenic"],"targets":[],"drugs":["sintilimab","bevacizumab","sorafenib"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":["hbv-hcv"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-ren-lancet-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03794440","phase":"2/3","setting":"First-line unresectable hepatocellular carcinoma, China (mostly hepatitis B-related): sintilimab plus the bevacizumab biosimilar IBI305 vs sorafenib","sponsor":"Innovent Biologics","participation":[{"nct":"NCT03794440","source":"https://clinicaltrials.gov/study/NCT03794440","fetchedAt":"2026-10-07T16:53:08.563Z","studySha256":"0d72742f20cba8da0aa9118d9ec69cd799dca644c74627c4c030d739658e0640","overallStatus":"UNKNOWN","lastUpdatePosted":"2021-01-22","leadSponsor":"Innovent Biologics (Suzhou) Co. Ltd.","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":595,"enrolmentType":"ACTUAL","siteCount":1,"recruitingSiteCount":0,"countries":["China"]}],"result":"OS HR 0.57; PFS HR 0.56.","started":"2019-02-11","startedType":"actual","yearReported":2021,"enrolled":595,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Sintilimab + IBI305","n":380,"note":"Median not reached at interim analysis"},{"name":"Sorafenib","n":191,"value":10.4}],"hr":0.57,"source":"https://doi.org/10.1016/S1470-2045(21)00252-7"}]},"route":"/trials/orient-32/","neighbours":{"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":"bevacizumab","kind":"drug","name":"Bevacizumab","route":"/drugs/bevacizumab/"},{"id":"sintilimab","kind":"drug","name":"Sintilimab","route":"/drugs/sintilimab/"},{"id":"sorafenib","kind":"drug","name":"Sorafenib","route":"/drugs/sorafenib/"}],"company":[{"id":"innovent","kind":"company","name":"Innovent Biologics","route":"/companies/innovent/"}],"term":[{"id":"hbv-hcv","kind":"term","name":"Hepatitis B and C as cancer causes","route":"/terms/hbv-hcv/"}],"paper":[{"id":"paper-ren-lancet-oncol","kind":"paper","name":"Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2-3 study","route":"/key-papers/paper-ren-lancet-oncol/"}]}}