{"entity":{"id":"captain-1st","kind":"trial","name":"CAPTAIN-1st","aka":[],"tldr":"CAPTAIN-1st showed that adding the PD-1 antibody camrelizumab to gemcitabine and cisplatin kept advanced nasopharyngeal cancer under control for about three months longer, confirming with a second drug what JUPITER-02 found with toripalimab.","summary":"CAPTAIN-1st randomised 263 patients with untreated recurrent or metastatic nasopharyngeal carcinoma at 28 Chinese centres to camrelizumab or placebo with gemcitabine and cisplatin for up to six cycles, followed by camrelizumab or placebo maintenance. Gemcitabine-cisplatin had been the standard since the 2016 GEM20110714 trial.\n\nReported by Yunpeng Yang and Li Zhang in Lancet Oncology in 2021, median progression-free survival was 9.7 months with camrelizumab against 6.9 months with placebo (hazard ratio 0.54). Camrelizumab's characteristic reactive capillary haemangiomas were the main additional toxicity.\n\nWith JUPITER-02 (toripalimab) and RATIONALE-309 (tislelizumab), it made PD-1 blockade with gemcitabine-cisplatin the first-line standard for advanced nasopharyngeal carcinoma in China and in the NCCN guideline; camrelizumab was approved for this use in China in 2021.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03707509","url":"https://clinicaltrials.gov/study/NCT03707509"}],"tags":[],"related":[],"cancers":["nasopharyngeal","head-and-neck"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["camrelizumab","gemcitabine-cisplatin","gemcitabine","cisplatin"],"companies":["hengrui"],"institutions":["sysucc"],"pathways":[],"terms":[],"trials":["jupiter-02"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03707509","phase":"3","setting":"Untreated recurrent or metastatic nasopharyngeal carcinoma: camrelizumab or placebo with gemcitabine and cisplatin, then camrelizumab or placebo maintenance","sponsor":"Jiangsu Hengrui","result":"Median progression-free survival 9.7 vs 6.9 months (hazard ratio 0.54).","yearReported":2021,"enrolled":263,"outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Camrelizumab + gemcitabine-cisplatin","value":9.7},{"name":"Placebo + gemcitabine-cisplatin","value":6.9}],"hr":0.54}],"replication":"JUPITER-02 (toripalimab) and RATIONALE-309 (tislelizumab) reported the same effect with different PD-1 antibodies."},"route":"/trials/captain-1st/","neighbours":{"cancer":[{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"nasopharyngeal","kind":"cancer","name":"Nasopharyngeal carcinoma","route":"/cancers/nasopharyngeal/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"drug":[{"id":"camrelizumab","kind":"drug","name":"Camrelizumab","route":"/drugs/camrelizumab/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"gemcitabine-cisplatin","kind":"drug","name":"Gemcitabine + cisplatin","route":"/drugs/gemcitabine-cisplatin/"}],"company":[{"id":"hengrui","kind":"company","name":"Jiangsu Hengrui Pharmaceuticals","route":"/companies/hengrui/"}],"institution":[{"id":"sysucc","kind":"institution","name":"Sun Yat-sen University Cancer Center","route":"/institutions/sysucc/"}],"trial":[{"id":"jupiter-02","kind":"trial","name":"JUPITER-02","route":"/trials/jupiter-02/"}]}}