# SHARP

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

## TL;DR

SHARP was the 2008 trial that gave liver cancer its first life-extending drug.

## Summary

SHARP, trial NCT00105443 sponsored by Bayer and reported in 2008, was the trial that gave liver cancer its first life-extending drug, sorafenib. It randomised 602 patients with advanced hepatocellular carcinoma and preserved liver function to sorafenib or placebo, met its primary overall survival endpoint and delayed radiological progression, while the response rate was only about two percent, establishing that disease stabilisation rather than shrinkage drives benefit with anti-angiogenic drugs. OnCo links it to hepatocellular carcinoma, sorafenib and Josep M. Llovet, and the result was confirmed by the parallel Asia-Pacific trial and a decade of real-world use as the control arm of later trials. Whether any of the many drugs that failed to beat sorafenib were undone by the trial design rather than by biology is the question its long reign left behind.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT00105443
- Phase: 3
- Setting: Advanced HCC, Child-Pugh A, no prior systemic therapy: sorafenib vs placebo
- Sponsor: Bayer
- Enrolled: 602
- Result: OS 10.7 vs 7.9 months, HR 0.69.
- Outcomes: Overall survival: Sorafenib 10.7 months vs Placebo 7.9 months, HR 0.69; Time to radiologic progression: Sorafenib 5.5 months vs Placebo 2.8 months, HR 0.58
- Replication: Confirmed by the parallel Asia-Pacific trial (Cheng 2009) and a decade of real-world use.

## Sources

- ClinicalTrials.gov NCT00105443: https://clinicaltrials.gov/study/NCT00105443

## 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: [Sorafenib](https://onco.cc/drugs/sorafenib/)
- companies: [Bayer](https://onco.cc/companies/bayer/)
- people: [Josep M. Llovet](https://onco.cc/people/josep-llovet/)
- key papers: [SHARP: sorafenib in advanced hepatocellular carcinoma](https://onco.cc/key-papers/paper-sharp-sorafenib-nejm-2008/)

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