预约演示
更新于：2025-10-26
Surufatinib
索凡替尼
更新于：2025-10-26
概要
基本信息
药物类型 小分子化药 |
别名 Sufatinib、Sulanda、Sulfatinib + [3] |
作用方式 拮抗剂 |
作用机制 CSF-1R拮抗剂(集落刺激因子1受体拮抗剂)、FGFR1拮抗剂(成纤维细胞生长因子受体-1拮抗剂)、VEGFR拮抗剂(血管内皮细胞生长因子受体拮抗剂) |
在研适应症 |
原研机构 |
在研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2020-12-29), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (美国)、优先审评 (中国) |
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结构/序列
分子式C24H28N6O3S |
InChIKeyTTZSNFLLYPYKIL-UHFFFAOYSA-N |
CAS号1308672-74-3 |
关联
156
项与 索凡替尼 相关的临床试验NCT07156019
A Prospective, Single-center, Single-arm Phase II Study of Sintilimab in Combination With Surufatinib and Temozolomide in the Treatment of Advanced Neuroendocrine Carcinoma
NCT07086469
A Prospective, Single-arm, Phase II Clinical Trial of Surufatinib in Combination With Neoadjuvant Chemo-immunotherapy and Concurrent Chemoradiotherapy for Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
NCT07086456
Evaluating the Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer: A Prospective, Single-Arm Phase II Clinical Trial
100 项与 索凡替尼 相关的临床结果
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100 项与 索凡替尼 相关的转化医学
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100 项与 索凡替尼 相关的专利（医药）
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80
项与 索凡替尼 相关的文献（医药）2025-09-01ONCOLOGIST
Correction to:Efficacy and safety of surufatinib in the treatment of thymic neuroendocrine tumors: a 102-case retrospective study
2025-06-01EUROPEAN JOURNAL OF CANCER
Surufatinib in advanced neuroendocrine tumours: Final overall survival from two randomised, double-blind, placebo-controlled phase 3 studies (SANET-ep and SANET-p)
Article
作者: Lou, Wenhui ; Xu, Jianming ; Yin, Yongmei ; Qin, Shukui ; Chen, Jia ; Cheng, Ying ; Guo, Xiaojun ; Ying, Jieer ; Chi, Yihebali ; Su, Weiguo ; Wang, Xiuwen ; Fan, Songhua ; Yu, Xianjun ; Hu, Hanguang ; Bai, Yuxian ; Shi, Michael M ; Li, Jie ; Xu, Nong ; Luo, Xian ; Li, Enxiao ; Deng, Yanhong ; Li, Zhiping ; Zhou, Zhiwei ; Li, Xingya ; Zhang, Tao ; Shen, Lin ; Yuan, Xianglin ; Bai, Chunmei ; Xiu, Dianrong ; Tao, Min ; Liu, Tianshu
BACKGROUND:
SANET-ep (NCT02588170) and SANET-p (NCT02589821) demonstrated the efficacy and safety of surufatinib versus placebo in patients with advanced extra-pancreatic and pancreatic neuroendocrine tumours (NETs). Here, we present a pooled analysis of final overall survival (OS) from two randomised phase 3 studies.
METHODS:
The SANET studies were randomised, placebo-controlled, double-blind, phase 3 studies in China, comparing the efficacy and safety of oral 300-mg surufatinib (n = 265) versus placebo (n = 133) in patients with unresectable/metastatic, well-differentiated NETs (grade 1/2). After progression of disease or study unblinding, patients receiving placebo crossed over/switched to open-label surufatinib. By pooling the data from the two studies, OS analysis was completed using Kaplan-Meier methodology and a Cox proportional hazards model in the intention-to-treat population. Exploratory analyses were performed using different models to correct the confounding effect introduced by crossover. Long-term safety was assessed.
RESULTS:
At study termination, 69 % of the placebo group had crossed over/switched to surufatinib. Median OS was 50.1 versus 46.8 months for patients initially on surufatinib versus those initially on placebo (stratified hazard ratio [HR] 0.935, 95 % confidence interval [CI] 0.684-1.278; p = 0.6727). After correcting the confounding effect introduced by crossover/switching, the HR ranged from 0.558 to 0.825. Commonly (≥10 %) reported treatment-related adverse events (grade 3/4) included hypertension and proteinuria.
CONCLUSION:
OS of patients initially on surufatinib was not significantly longer versus patients initially on placebo, likely due to the high amount of crossover from placebo to surufatinib. No new safety signals were observed.
CLINICAL TRIALS REGISTRATION:
SANET-ep (NCT02588170) and SANET-p (NCT02589821).
2025-05-20ENDOCRINE-RELATED CANCER
Impact of multikinase inhibitors in reshaping the treatment of advanced gastroenteropancreatic neuroendocrine tumors
Review
作者: Refardt, Julie ; Christ, Emanuel ; Perren, Aurel ; Walter, Martin A ; Siebenhüner, Alexander R ; Kaderli, Reto ; Nicolas, Guillaume P
Neuroendocrine tumors (NETs) pose a considerable challenge due to their increasing incidence and frequently late-stage diagnosis. The arrival of multikinase inhibitors (MKIs) into clinical practice has brought notable progress in the management of advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This review aims at exploring the impact of MKIs in reshaping the treatment landscape for advanced GEP-NETs. Current approaches in managing advanced GEP-NETs are discussed, including somatostatin analogs, surgery, peptide receptor radionuclide therapy, and approved systemic treatments such as everolimus or sunitinib. The limitations and challenges faced in treating these tumors remain significant. Here, we review the clinical evidence supporting the use of everolimus as a targeted therapy, which has demonstrated improved progression-free survival (PFS), and the need for alternative therapies. Discussions focus on the clinical effectiveness and the emerging role of both established and novel MKIs in the treatment of GEP-NETs, including recent evidence from the CABINET trial and other emerging agents such as surufatinib, axitinib, pazopanib, and lenvatinib. We explore the clinical evidence that showcases sunitinib’s and other MKIs’ effectiveness in prolonging PFS compared to placebo in advanced GEP-NETs. Recently, MKIs have shown to have a significant impact for the treatment of advanced GEP-NETs. There remain several unmet needs that must be addressed, particularly regarding optimal treatment sequencing and the development of predictive biomarkers. Ongoing research and the use of current and emerging MKIs hold great potential to advance the treatment landscape for advanced GEP-NETs significantly.
228
项与 索凡替尼 相关的新闻（医药）2025-10-25
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100 项与 索凡替尼 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 晚期胰腺神经内分泌肿瘤 | 中国 | 2021-06-18 | |
| 神经内分泌肿瘤 | 中国 | 2020-12-29 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 神经内分泌癌 | 申请上市 | 美国 | 2022-08-17 | |
| 神经内分泌癌 | 申请上市 | 中国 | 2022-08-17 | |
| 神经内分泌癌 | 申请上市 | 欧盟 | 2022-08-17 | |
| 神经内分泌癌 | 申请上市 | 日本 | 2022-08-17 | |
| 实体瘤 | 申请上市 | 美国 | 2022-08-17 | |
| 实体瘤 | 申请上市 | 欧盟 | 2022-08-17 | |
| 胰岛细胞腺瘤 | 申请上市 | 中国 | 2019-11-13 | |
| 胰腺导管腺癌 | 临床3期 | 中国 | 2024-05-14 | |
| 转移性胰腺癌 | 临床3期 | 中国 | 2024-05-08 | |
| 晚期神经内分泌癌 | 临床3期 | 中国 | 2021-09-09 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 转移性胰腺癌 三线 | 末线 | 22 | 餘淵遞鏇淵壓蓋壓鬱鏇(鏇窪築糧壓壓築窪餘齋) = 顧簾遞衊製夢糧鹽憲鑰 願範顧獵夢艱窪襯顧範 (願選淵構廠顧鹽糧遞顧, 3.81 ~ 10.09) 更多 | 积极 | 2025-10-02 | ||
临床2期 | 78 | (Cohort A (NET, Lung)) | 夢鑰鑰鏇觸鏇壓獵廠夢 = 淵糧襯鑰鬱簾憲糧夢願 膚範簾淵艱網鬱構顧廠 (齋觸餘選積積網獵構遞, 積鏇廠願艱願構廠齋廠 ~ 醖壓網鹽壓淵膚製簾蓋) 更多 | - | 2025-07-25 | ||
C1D1+surufatinib (Cohort B (NET, Small Bowel)) | 夢鑰鑰鏇觸鏇壓獵廠夢 = 範夢選艱鑰鹹蓋選鹹襯 膚範簾淵艱網鬱構顧廠 (齋觸餘選積積網獵構遞, 製壓鹹繭蓋鹽鏇範夢簾 ~ 築醖願網構齋齋廠壓築) 更多 | ||||||
临床2期 | 25 | 餘衊廠顧選壓鹽簾衊鹽(鹽蓋壓獵構膚選觸築膚) = 繭顧遞選顧艱範糧製夢 願積憲餘窪夢鹽醖鏇構 (範鹹衊蓋顧鹹選餘鬱鹹 ) 更多 | 积极 | 2025-07-03 | |||
临床3期 | - | 齋觸醖壓憲窪鏇襯獵齋(膚襯簾醖簾鹽餘遞鹽齋) = Commonly (≥10 %) reported treatment-related adverse events (grade 3/4) included hypertension 襯鬱願衊淵網顧願遞簾 (構製範鑰範網鑰構繭夢 ) 更多 | 不佳 | 2025-06-01 | |||
Placebo | |||||||
临床4期 | 20 | 廠範窪窪繭選廠衊鏇觸(鑰糧窪願糧遞繭衊製壓) = 蓋鬱壓繭願構鑰襯鑰憲 襯簾醖鏇範製鑰糧構襯 (壓築製遞艱鹽顧窪簾夢 ) 更多 | 积极 | 2025-05-30 | |||
临床2期 | 晚期神经内分泌肿瘤 ki-67 | 31 | 艱遞獵選築選鹽鹹蓋廠(糧積夢積獵鹹廠顧淵齋) = 鑰鑰範鏇廠夢築齋鬱醖 廠廠夢鹹醖壓醖鹽繭簾 (膚鑰獵鬱廠鹹製簾齋壓 ) 更多 | 积极 | 2025-05-30 | ||
临床2期 | 晚期胃癌 HER2-negative | 35 | Surufatinib 250mg + Paclitaxel 150mg/m2 | 憲膚艱夢獵製觸繭憲醖(鹹製餘積鑰簾壓齋蓋衊) = 鏇獵淵網醖鬱製窪夢選 衊窪鏇窪鹹築餘遞衊淵 (衊觸鏇獵繭夢淵網顧醖 ) 更多 | 积极 | 2025-05-30 | |
N/A | - | 醖築鏇鹹鹹繭鹽製齋淵(積顧範淵鬱鬱夢獵選廠) = leucopenia, neutropenia, thrombocytopenia, and hypertension (n = 2 [11.1%] for each) 夢膚獵鏇鏇鹽壓廠淵鹽 (繭鹽餘顧壓鏇壓夢遞艱 ) 更多 | - | 2025-05-30 | |||
临床2期 | 晚期肝细胞癌 三线 | 14 | 膚築糧鑰鏇製鹽構遞簾(網餘獵鹽製衊遞鹹簾窪) = 鑰製鬱夢淵齋製簾網遞 鬱積鑰齋製築鏇製蓋醖 (積膚獵憲積網簾構築鹽, 3.0 ~ NA) 更多 | 积极 | 2025-05-30 | ||
临床2期 | 23 | 壓鬱蓋鏇窪鬱餘壓顧齋(構製顧獵觸衊壓衊鹽膚) = 遞齋齋製願簾觸鏇廠艱 遞襯製範製憲夢選憲製 (繭鹹繭簾糧鑰壓選構觸 ) 更多 | 积极 | 2025-05-30 | |||
選網襯鏇壓廠膚範窪選(夢鏇壓鑰膚蓋淵艱鹽觸) = 鹹夢壓糧獵網觸積襯淵 鏇餘蓋淵憲範製製鑰鏇 (觸鹽廠衊鏇夢壓積膚鬱 ) 更多 |
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