# ZGDH3 (donafenib vs sorafenib)

Source: https://onco.cc/trials/zgdh3/  
OnCo record `zgdh3` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first trial in which a new pill beat sorafenib on survival in liver cancer, with a Chinese deuterated redesign of sorafenib itself.

## Summary

668 patients, open label. Median overall survival 12.1 versus 10.3 months (hazard ratio 0.83) with fewer grade 3 or higher adverse events; published in the Journal of Clinical Oncology 2021. NMPA approval June 2021. A small gain, but the first head-to-head overall survival win against sorafenib and an example of incremental medicinal chemistry rewarded in China's market.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-10
- Tags: china
- Registry id: NCT02645981
- Phase: 2/3
- Setting: First-line unresectable or metastatic hepatocellular carcinoma, China: donafenib vs sorafenib
- Sponsor: Suzhou Zelgen Biopharmaceuticals
- Enrolled: 668
- Result: OS 12.1 vs 10.3 months, HR 0.83.
- Outcomes: Overall survival: Donafenib 12.1 months vs Sorafenib 10.3 months, HR 0.83

## Sources

- ClinicalTrials.gov NCT02645981: https://clinicaltrials.gov/study/NCT02645981
- J Clin Oncol 2021: https://doi.org/10.1200/JCO.20.02672

## Connected records

- cancers: [Hepatocellular carcinoma](https://onco.cc/cancers/hcc/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Donafenib](https://onco.cc/drugs/donafenib/), [Sorafenib](https://onco.cc/drugs/sorafenib/)
- companies: [Suzhou Zelgen Biopharmaceuticals](https://onco.cc/companies/zelgen/)
- people: [Shukui Qin](https://onco.cc/people/qin-shukui/)
- key papers: [Systemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline](https://onco.cc/key-papers/paper-gordan-j-clin-oncol/)

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