{"entity":{"id":"rationale-302","kind":"trial","name":"RATIONALE-302","aka":[],"tldr":"The global trial in which tislelizumab beat chemotherapy for oesophageal cancer that had progressed after first treatment, which carried it to approval in the US, Europe and Japan.","summary":"512 patients from 11 countries. Median overall survival 8.6 versus 6.3 months (hazard ratio 0.70), with greater benefit at PD-L1 TAP 10% or more (10.3 versus 6.8 months). Because it enrolled outside China it underpinned the EU approval (2023), the first FDA approval of tislelizumab (March 2024) and Japanese approval, in contrast to the China-only PD-1 filings that failed in the US.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03430843","url":"https://clinicaltrials.gov/study/NCT03430843"},{"label":"J Clin Oncol 2022","url":"https://doi.org/10.1200/JCO.21.01926"}],"tags":["china"],"related":[],"cancers":["esophageal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["tislelizumab"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-shen-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03430843","phase":"3","setting":"Second-line advanced or metastatic oesophageal squamous cell carcinoma, global (Asia, Europe, North America): tislelizumab vs investigator's choice chemotherapy","sponsor":"BeiGene (BeOne Medicines)","result":"OS 8.6 vs 6.3 months, HR 0.70.","started":"2018-01-26","startedType":"actual","yearReported":2022,"enrolled":512,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Tislelizumab","n":256,"value":8.6},{"name":"Chemotherapy","n":256,"value":6.3}],"hr":0.7,"source":"https://doi.org/10.1200/JCO.21.01926"}]},"route":"/trials/rationale-302/","neighbours":{"cancer":[{"id":"esophageal","kind":"cancer","name":"Oesophageal cancer","route":"/cancers/esophageal/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"tislelizumab","kind":"drug","name":"Tislelizumab","route":"/drugs/tislelizumab/"}],"company":[{"id":"beone","kind":"company","name":"BeOne Medicines (formerly BeiGene)","route":"/companies/beone/"}],"paper":[{"id":"paper-shen-j-clin-oncol","kind":"paper","name":"Tislelizumab Versus Chemotherapy as Second-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma (RATIONALE-302): A Randomized Phase III Study","route":"/key-papers/paper-shen-j-clin-oncol/"}]}}