{"entity":{"id":"fresco","kind":"trial","name":"FRESCO","aka":[],"tldr":"The Chinese trial that first showed fruquintinib works. FRESCO-2 then repeated it worldwide in patients who had already had everything.","summary":"FRESCO randomised 416 patients at 28 Chinese hospitals 2:1 to fruquintinib 5 mg daily, three weeks on and one off, or placebo after at least two lines of chemotherapy, excluding patients who had already had a VEGFR inhibitor. Median overall survival was 9.3 against 6.6 months (hazard ratio 0.65, 95% CI 0.51 to 0.83). Fruquintinib was approved in China in 2018 on this trial. FRESCO-2 then tested it in a heavily pretreated global population who had progressed on or could not tolerate trifluridine/tipiracil or regorafenib, reaching 7.4 against 4.8 months, and led to the FDA approval on 8 November 2023, the EU marketing authorisation for Fruzaqla on 20 June 2024 and NICE TA1079 in July 2025.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02314819","url":"https://clinicaltrials.gov/study/NCT02314819"},{"label":"FRESCO: fruquintinib versus placebo in previously treated metastatic colorectal cancer (JAMA 2018)","url":"https://doi.org/10.1001/jama.2018.7855"},{"label":"EMA Fruzaqla","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/fruzaqla"},{"label":"NICE TA1079: fruquintinib for previously treated metastatic colorectal cancer","url":"https://www.nice.org.uk/guidance/ta1079"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["kinase-inhibitors","antiangiogenic"],"targets":["vegf"],"drugs":["fruquintinib"],"companies":["hutchmed"],"institutions":[],"pathways":[],"terms":[],"trials":["fresco-2"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02314819","phase":"3","setting":"Chinese patients with metastatic colorectal cancer progressing after at least two lines of chemotherapy and no previous VEGFR inhibitor: fruquintinib against placebo","sponsor":"Hutchison Medipharma","result":"Median overall survival 9.3 against 6.6 months (hazard ratio 0.65).","yearReported":2018,"enrolled":416,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Fruquintinib","n":278,"value":9.3},{"name":"Placebo","n":138,"value":6.6}],"hr":0.65,"ci":[0.51,0.83],"source":"https://doi.org/10.1001/jama.2018.7855"}],"replication":"FRESCO-2 replicated the effect internationally in a more heavily pretreated population."},"route":"/trials/fresco/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"vegf","kind":"target","name":"VEGF / VEGFR","route":"/targets/vegf/"}],"drug":[{"id":"fruquintinib","kind":"drug","name":"Fruquintinib","route":"/drugs/fruquintinib/"}],"company":[{"id":"hutchmed","kind":"company","name":"Hutchmed","route":"/companies/hutchmed/"}],"trial":[{"id":"fresco-2","kind":"trial","name":"FRESCO-2","route":"/trials/fresco-2/"},{"id":"sunlight","kind":"trial","name":"SUNLIGHT","route":"/trials/sunlight/"}]}}