# SHARP: sorafenib in advanced hepatocellular carcinoma

Source: https://onco.cc/key-papers/paper-sharp-sorafenib-nejm-2008/  
OnCo record `paper-sharp-sorafenib-nejm-2008` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Sorafenib was the first systemic drug to lengthen survival in advanced liver cancer, adding almost three months compared with placebo, and remained the only option for a decade.

## Summary

Phase 3 placebo-controlled trial of 602 patients with advanced hepatocellular carcinoma and preserved liver function (Child-Pugh A) randomised to sorafenib 400 mg twice daily or placebo.

Median overall survival was 10.7 versus 7.9 months (hazard ratio 0.69), time to radiological progression 5.5 versus 2.8 months, with response in only 2 percent; diarrhoea, weight loss and hand-foot skin reaction were the main toxicities.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2008
- DOI: 10.1056/NEJMoa0708857
- Authors: Llovet JM, Ricci S, Mazzaferro V, et al.
- Findings: Median overall survival 10.7 vs 7.9 months; hazard ratio 0.69.; Time to radiological progression 5.5 vs 2.8 months.
- What it means: Sorafenib became the reference standard against which lenvatinib, atezolizumab-bevacizumab and durvalumab-tremelimumab were tested, and remains an option where immunotherapy is unsuitable.
- Caveats: Benefit confined to patients with good liver function.; Very low response rate; benefit is disease stabilisation.

## Sources

- N Engl J Med 2008: https://doi.org/10.1056/NEJMoa0708857
- PubMed: https://pubmed.ncbi.nlm.nih.gov/18650514/

## Connected records

- cancers: [Advanced hepatocellular carcinoma (BCLC C)](https://onco.cc/cancers/hcc-advanced/)
- drugs: [Sorafenib](https://onco.cc/drugs/sorafenib/)
- trials: [SHARP](https://onco.cc/trials/sharp/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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