{"entity":{"id":"orient-16","kind":"trial","name":"ORIENT-16","aka":[],"tldr":"The Chinese stomach cancer trial that showed adding sintilimab to chemotherapy helps patients live longer, especially when the tumour expresses PD-L1.","summary":"650 patients. Median overall survival 15.2 versus 12.3 months in all randomised patients (hazard ratio 0.77) and 18.4 versus 12.9 months in the PD-L1 CPS 5 or higher group (hazard ratio 0.66), published in JAMA in 2023. NMPA approval 2023. With CheckMate 649, KEYNOTE-859 and RATIONALE-305 it makes gastric cancer the disease where Chinese PD-1 trials most changed global practice.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03745170","url":"https://clinicaltrials.gov/study/NCT03745170"},{"label":"JAMA 2023","url":"https://doi.org/10.1001/jama.2023.19918"}],"tags":["china"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["sintilimab","oxaliplatin"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":["cps"],"trials":[],"people":["xu-jianming"],"bottlenecks":[],"keyPapers":["paper-xu-jama"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03745170","phase":"3","setting":"First-line unresectable gastric or gastro-oesophageal junction adenocarcinoma, China: sintilimab or placebo plus oxaliplatin and capecitabine","sponsor":"Innovent Biologics","result":"OS 15.2 vs 12.3 months (HR 0.77); CPS ≥5: 18.4 vs 12.9 months (HR 0.66).","started":"2018-12-19","startedType":"actual","yearReported":2023,"enrolled":650,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival, all randomised","primary":true,"unit":"months","arms":[{"name":"Sintilimab + CAPOX","n":327,"value":15.2},{"name":"Placebo + CAPOX","n":323,"value":12.3}],"hr":0.77,"source":"https://doi.org/10.1001/jama.2023.19918"}]},"route":"/trials/orient-16/","neighbours":{"cancer":[{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"oxaliplatin","kind":"drug","name":"Oxaliplatin","route":"/drugs/oxaliplatin/"},{"id":"sintilimab","kind":"drug","name":"Sintilimab","route":"/drugs/sintilimab/"}],"company":[{"id":"innovent","kind":"company","name":"Innovent Biologics","route":"/companies/innovent/"}],"term":[{"id":"cps","kind":"term","name":"Combined positive score (CPS)","route":"/terms/cps/"}],"person":[{"id":"xu-jianming","kind":"person","name":"Jianming Xu","route":"/people/xu-jianming/"}],"paper":[{"id":"paper-xu-jama","kind":"paper","name":"Sintilimab Plus Chemotherapy for Unresectable Gastric or Gastroesophageal Junction Cancer: The ORIENT-16 Randomized Clinical Trial","route":"/key-papers/paper-xu-jama/"}]}}