# FRESCO

Source: https://onco.cc/trials/fresco/  
OnCo record `fresco` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-24
- Registry id: 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
- Enrolled: 416
- Result: Median overall survival 9.3 against 6.6 months (hazard ratio 0.65).
- Outcomes: Overall survival: Fruquintinib 9.3 months vs Placebo 6.6 months, HR 0.65
- Replication: FRESCO-2 replicated the effect internationally in a more heavily pretreated population.

## Sources

- ClinicalTrials.gov NCT02314819: https://clinicaltrials.gov/study/NCT02314819
- FRESCO: fruquintinib versus placebo in previously treated metastatic colorectal cancer (JAMA 2018): https://doi.org/10.1001/jama.2018.7855
- EMA Fruzaqla: https://www.ema.europa.eu/en/medicines/human/EPAR/fruzaqla
- NICE TA1079: fruquintinib for previously treated metastatic colorectal cancer: https://www.nice.org.uk/guidance/ta1079

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- technologies: [Anti-angiogenic therapy](https://onco.cc/technologies/antiangiogenic/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [VEGF / VEGFR](https://onco.cc/targets/vegf/)
- drugs: [Fruquintinib](https://onco.cc/drugs/fruquintinib/)
- companies: [Hutchmed](https://onco.cc/companies/hutchmed/)
- trials: [FRESCO-2](https://onco.cc/trials/fresco-2/), [SUNLIGHT](https://onco.cc/trials/sunlight/)

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JSON: https://onco.cc/api/v1/entities/fresco.json