{"entity":{"id":"continuum","kind":"trial","name":"CONTINUUM","aka":["2018-FXY-135-FLK"],"tldr":"CONTINUUM was the first trial to show that adding a PD-1 immunotherapy, sintilimab, to the chemotherapy and radiotherapy given for advanced but not yet metastatic nasopharyngeal cancer keeps more people free of relapse three years later, 86 against 76 percent, at the cost of more side effects.","summary":"CONTINUUM was an open-label randomised phase 3 trial at nine hospitals in China that randomised 425 adults with high-risk locoregionally advanced nasopharyngeal carcinoma to standard gemcitabine-cisplatin induction followed by concurrent cisplatin radiotherapy, with or without sintilimab 200 mg every three weeks for 12 cycles spanning induction, concurrent and adjuvant phases. The primary endpoint was event-free survival.\n\nAt a median follow-up of 41.9 months, three-year event-free survival was 86 percent with sintilimab against 76 percent without (hazard ratio 0.59). Grade 3 to 4 adverse events were 74 against 65 percent, grade 3 to 4 immune-related events occurred in 10 percent of the sintilimab group and two immune-related deaths occurred. The corpus's locoregionally advanced nasopharyngeal carcinoma page cites CONTINUUM for adding a PD-1 antibody to chemoradiotherapy, with toripalimab and camrelizumab in parallel trials.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03700476","url":"https://clinicaltrials.gov/study/NCT03700476"}],"tags":["soc-trials"],"related":[],"cancers":["locoregionally-advanced-nasopharyngeal-carcinoma","nasopharyngeal"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt","cytotoxic-chemotherapy"],"targets":[],"drugs":["sintilimab","gemcitabine","cisplatin"],"companies":["innovent"],"institutions":["sysucc"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-continuum-sintilimab-nasopharyngeal-liu-lancet-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03700476","phase":"3","setting":"High-risk locoregionally advanced nasopharyngeal carcinoma (stage III to IVa, excluding T3-4N0 and T3N1) in adults aged 18 to 65 at nine Chinese hospitals: gemcitabine-cisplatin induction and concurrent cisplatin radiotherapy with or without 12 cycles of the PD-1 antibody sintilimab, with event-free survival as the primary endpoint","sponsor":"Sun Yat-sen University Cancer Center","result":"Three-year event-free survival 86 percent with sintilimab added to chemoradiotherapy against 76 percent without (hazard ratio 0.59, p 0.019); grade 3 to 4 adverse events 74 against 65 percent.","yearReported":2024,"enrolled":425,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Sintilimab + induction chemotherapy + concurrent chemoradiotherapy","n":210,"value":86,"note":"95% CI 81 to 90; median follow-up 41.9 months"},{"name":"Induction chemotherapy + concurrent chemoradiotherapy","n":215,"value":76,"note":"95% CI 70 to 81"}],"hr":0.59,"ci":[0.38,0.92],"p":"0.019","source":"https://doi.org/10.1016/S0140-6736(24)00594-4"},{"endpoint":"Grade 3 to 4 adverse events","unit":"%","arms":[{"name":"Sintilimab + chemoradiotherapy","n":210,"value":74},{"name":"Chemoradiotherapy","n":215,"value":65}],"source":"https://doi.org/10.1016/S0140-6736(24)00594-4"},{"endpoint":"Grade 3 to 4 immune-related adverse events","unit":"%","arms":[{"name":"Sintilimab + chemoradiotherapy","n":210,"value":10,"note":"20 patients; 2 immune-related deaths"}],"source":"https://doi.org/10.1016/S0140-6736(24)00594-4"}]},"route":"/trials/continuum/","neighbours":{"cancer":[{"id":"locoregionally-advanced-nasopharyngeal-carcinoma","kind":"cancer","name":"Locoregionally advanced nasopharyngeal carcinoma (stage III to IVA)","route":"/cancers/locoregionally-advanced-nasopharyngeal-carcinoma/"},{"id":"nasopharyngeal","kind":"cancer","name":"Nasopharyngeal carcinoma","route":"/cancers/nasopharyngeal/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"}],"drug":[{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"sintilimab","kind":"drug","name":"Sintilimab","route":"/drugs/sintilimab/"}],"company":[{"id":"innovent","kind":"company","name":"Innovent Biologics","route":"/companies/innovent/"}],"institution":[{"id":"sysucc","kind":"institution","name":"Sun Yat-sen University Cancer Center","route":"/institutions/sysucc/"}],"paper":[{"id":"paper-continuum-sintilimab-nasopharyngeal-liu-lancet-2024","kind":"paper","name":"CONTINUUM: induction-concurrent chemoradiotherapy with or without sintilimab in locoregionally advanced nasopharyngeal carcinoma","route":"/key-papers/paper-continuum-sintilimab-nasopharyngeal-liu-lancet-2024/"}]}}