Phase III Study of Surufatinib in Treating Advanced Extrapancreatic Neuroendocrine Tumors

Summary

A randomized, double-blind, placebo controlled, multi-center Phase III study to assess the efficacy of Surufatinib 300 mg once a day in treating advanced extrapancreatic neuroendocrine tumors.

Timeline

Start

2015-12-07

Primary completion

2019-03-31

Completion

2022-07-07

Publications

• Xu J, Shen L, Li J, Zhou Z, Bai C, Li Z, Chi Y, Li E, Yu X, Xu N, Bai Y, Wang X, Yuan X, Liu T, Yin Y, Chen J, Hu H, Li X, Xiu D, Zhang T, Lou W, Ying J, Qin S, Deng Y, Tao M, Cheng Y, Fan S, Luo X, Guo X, Shi MM, Su W. Surufatinib in advanced neuroendocrine tumours: Final overall survival from two randomised, double-blind, placebo-controlled phase 3 studies (SANET-ep and SANET-p). Eur J Cancer. 2025 Jun 3;222:115398. doi: 10.1016/j.ejca.2025.115398. Epub 2025 Mar 30.
• Li J, Cheng Y, Bai C, Xu J, Shen L, Li J, Zhou Z, Li Z, Chi Y, Yu X, Li E, Xu N, Liu T, Lou W, Bai Y, Yuan X, Wang X, Yuan Y, Chen J, Guan S, Fan S, Su W. Health-related quality of life in patients with advanced well-differentiated pancreatic and extrapancreatic neuroendocrine tumors treated with surufatinib versus placebo: Results from two randomized, double-blind, phase III trials (SANET-p and SANET-ep). Eur J Cancer. 2022 Jul;169:1-9. doi: 10.1016/j.ejca.2022.03.027. Epub 2022 Apr 28.
• Li J, Cheng Y, Bai C, Xu J, Shen L, Li J, Zhou Z, Li Z, Chi Y, Yu X, Li E, Xu N, Liu T, Lou W, Bai Y, Yuan X, Wang X, Yuan Y, Chen J, Guan S, Fan S, Su W. Treatment-related adverse events as predictive biomarkers of efficacy in patients with advanced neuroendocrine tumors treated with surufatinib: results from two phase III studies. ESMO Open. 2022 Apr;7(2):100453. doi: 10.1016/j.esmoop.2022.100453. Epub 2022 Mar 25.
• Xu J, Shen L, Zhou Z, Li J, Bai C, Chi Y, Li Z, Xu N, Li E, Liu T, Bai Y, Yuan Y, Li X, Wang X, Chen J, Ying J, Yu X, Qin S, Yuan X, Zhang T, Deng Y, Xiu D, Cheng Y, Tao M, Jia R, Wang W, Li J, Fan S, Peng M, Su W. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Nov;21(11):1500-1512. doi: 10.1016/S1470-2045(20)30496-4. Epub 2020 Sep 20.

Drugs

Indications