# SANET-ep and SANET-p

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

## TL;DR

In the SANET trials, a Chinese anti-angiogenic pill slowed both gut and pancreatic neuroendocrine tumours, but its US application was refused.

## Summary

SANET-ep and SANET-p, led by trial NCT02588170 and sponsored by Hutchmed, showed in 2020 that the Chinese anti-angiogenic tablet surufatinib slows both extra-pancreatic and pancreatic neuroendocrine tumours, but its US application was refused. The two trials randomised 198 patients with extra-pancreatic and 172 with pancreatic progressive tumours to surufatinib or placebo in China, and both met their primary progression-free survival endpoints with large effects, leading to approval in China in 2020 and 2021, while the FDA issued a complete response letter in 2022 requiring a multiregional trial. OnCo links them to neuroendocrine tumours, anti-angiogenic therapy and VEGF and VEGFR as targets. Whether a single-country trial can ever support a US approval is the wider question the refusal raised.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Tags: lesson:single-region-data
- Registry id: NCT02588170
- Phase: 3
- Setting: Progressive extra-pancreatic (n=198) and pancreatic (n=172) NETs: surufatinib vs placebo (China)
- Sponsor: Hutchmed
- Enrolled: 369
- Result: PFS HR 0.33 (ep), 0.49 (p).
- Outcomes: Progression-free survival (SANET-ep): Surufatinib 9.2 months vs Placebo 3.8 months, HR 0.33; Progression-free survival (SANET-p): Surufatinib 10.9 months vs Placebo 3.7 months, HR 0.49

## Sources

- ClinicalTrials.gov NCT02588170: https://clinicaltrials.gov/study/NCT02588170

## Connected records

- cancers: [Neuroendocrine tumours](https://onco.cc/cancers/neuroendocrine/)
- technologies: [Anti-angiogenic therapy](https://onco.cc/technologies/antiangiogenic/)
- targets: [VEGF / VEGFR](https://onco.cc/targets/vegf/)
- drugs: [Surufatinib](https://onco.cc/drugs/surufatinib/)
- companies: [Hutchmed](https://onco.cc/companies/hutchmed/)

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