# REFLECT

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

## TL;DR

Lenvatinib matched sorafenib on survival with more tumour shrinkage, giving a second first-line option after a decade.

## Summary

REFLECT, trial NCT01761266 sponsored by Eisai and reported in 2018, showed that lenvatinib matched sorafenib on survival with more tumour shrinkage, giving first-line unresectable hepatocellular carcinoma a second option after a decade. It randomised 954 patients in a non-inferiority design, met its primary overall survival endpoint for non-inferiority, and improved progression-free survival and response rate by modified RECIST, making it the first positive first-line trial since SHARP. OnCo links it to hepatocellular carcinoma, lenvatinib, sorafenib, Ann-Lii Cheng and Masatoshi Kudo. Because it showed equivalence rather than superiority, whether lenvatinib's higher response rate matters clinically, particularly before local therapies, remains the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT01761266
- Phase: 3
- Setting: First-line unresectable HCC: lenvatinib vs sorafenib (non-inferiority)
- Sponsor: Eisai
- Enrolled: 954
- Result: OS 13.6 vs 12.3 months, non-inferior (HR 0.92).
- Outcomes: Overall survival: Lenvatinib 13.6 months vs Sorafenib 12.3 months, HR 0.92; Progression-free survival: Lenvatinib 7.4 months vs Sorafenib 3.7 months, HR 0.66

## Sources

- ClinicalTrials.gov NCT01761266: https://clinicaltrials.gov/study/NCT01761266

## Connected records

- cancers: [Advanced hepatocellular carcinoma (BCLC C)](https://onco.cc/cancers/hcc-advanced/), [Hepatocellular carcinoma](https://onco.cc/cancers/hcc/)
- technologies: [Anti-angiogenic therapy](https://onco.cc/technologies/antiangiogenic/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Lenvatinib](https://onco.cc/drugs/lenvatinib/), [Sorafenib](https://onco.cc/drugs/sorafenib/)
- companies: [Eisai](https://onco.cc/companies/eisai/)
- people: [Ann-Lii Cheng](https://onco.cc/people/ann-lii-cheng/), [Masatoshi Kudo](https://onco.cc/people/masatoshi-kudo/)
- key papers: [REFLECT: lenvatinib versus sorafenib in first-line treatment of unresectable hepatocellular carcinoma](https://onco.cc/key-papers/paper-reflect-lenvatinib-lancet-2018/)

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