更新于：2024-11-04
Surufatinib
索凡替尼
更新于：2024-11-04
概要
基本信息
药物类型 小分子化药 |
别名 Sufatinib、Sulanda、Sulfatinib + [3] |
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 |
最高研发阶段批准上市 |
首次获批日期 中国 (2021-06-18), |
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
分子式C24H28N6O3S |
InChIKeyTTZSNFLLYPYKIL-UHFFFAOYSA-N |
CAS号1308672-74-3 |
关联
130
项与 索凡替尼 相关的临床试验A Single-arm, Open-label, Prospective Clinical Study of Surufatinib Combined With Immunotherapy and Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer.
Endoscopic Retrograde Cholangiopancreatography With Radiofrequency Ablation (ERCP-RFA) Combined With Envafolimab and Surufatinib Sequential Therapy for Unresectable Biliary Tract Carcinoma: A Prospective, Single-Arm, Single-Center Phase II Clinical Study
Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation: A Single-arm, Multi-cohort, Open-label, Single-center, Prospective, Exploratory Clinical Study
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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52
项与 索凡替尼 相关的文献（医药）2024-10-23Zhonghua zhong liu za zhi [Chinese journal of oncology]
[Chinese multidisciplinary expert consensus on the rational use of surufatinib in clinical practice（2024 edition）].
Article
Neuroendocrine neoplasms are a group of heterogeneous tumors originating from the neuroendocrine system, which can occur in any part of the body. Pulmonary and gastroenteropancreatic neuroendocrine tumors are the most common. In recent years, the global incidence of neuroendocrine tumors has increased more significantly than other types of tumors, especially in the past 40 years. The drug treatment of neuroendocrine tumors includes somatostatin analogues, anti-angiogenesis targeting drugs, nuclide therapy and chemotherapy. Surufatinib is an oral tyrosine kinase receptor inhibitors that targets for vascular endothelial growth factor receptor (VEGFR1-3), fibroblast growth factor receptor 1 (FGFR1), and colony-stimulating factor-1 receptor (CSF-1R), has received approval in 2020 and 2021 for the treatment of locally advanced or metastatic, progressive nonfunctional, well-differentiated (G1, G2) neuroendocrine tumors (NETs) of both pancreatic and extrapancreatic origin that are unresectable. Ongoing exploratory studies are investigating its potential application in other tumor types. Common adverse reactions observed during surufatinib treatment include hypertension, proteinuria, bleeding events, and hepatic lab test abnormal and diarrhea. Chinese multidisciplinary expert consensus on the rational use of surufatinib in clinical practice (2024 edition) aims to provide standardized guidance for its rational use and enhance patient compliance to maximize therapeutic benefits.
2024-09-01Heliyon
Efficacy of surufatinib in the treatment of advanced parathyroid carcinoma: A case report
Article
作者: Xie, Xiaojun ; Zhou, Jie ; Wang, Junli ; Li, Xuan ; Chen, Linghui ; Hu, Liang ; Yu, Zhiyong ; Wu, Yijun ; Zhang, Qijun ; Li, Fuqiang
Parathyroid cancer is an extremely rare form of neuroendocrine malignancy. Apart from surgery, the effectiveness of chemotherapy and radiotherapy is limited, and the efficacy of targeted drugs remains unclear. In this study, we demonstrate the therapeutic effectiveness and adverse reaction of the targeted drug surufatinib in treating a case of parathyroid cancer, and concurrently review the recent advancements in the treatment of parathyroid cancer. The patient, a 55-year-old male, underwent his first surgery for a "right cervical mass" in May 2011. Postoperative pathology indicated an atypical adenoma of the parathyroid gland. In August 2016, the patient underwent a second surgery for recurrence of the right cervical tumor, with a pathological diagnosis of parathyroid cancer based on clinical history. In November 2017, the patient underwent a third surgery for recurrence of the right cervical tumor. In December 2017, the patient underwent adjuvant external radiation therapy. In August 2022, the patient developed spinal and lung metastases and underwent spinal surgery. Subsequently, the patient received three rounds of chemotherapy on October 5, 2022, October 28, 2022, and November 18, 2022, but the tumor showed slight enlargement. In January 2023, the patient began treatment with surufatinib. After two cycles of treatment, the tumor showed regression. Given the scarcity of systemic treatment options for parathyroid cancer, the targeted drug surufatinib may offer a promising potential treatment option.
2024-04-01Cancer medicine
Surufatinib combined with transarterial embolization versus surufatinib monotherapy in patients with liver metastatic neuroendocrine tumors: Study protocol for a prospective, randomized, controlled trial
Article
作者: Li, Ruizhen ; Su, Minggang ; Ke, Nengwen ; Li, Xiaofen ; Cao, Dan ; Liu, Yuzhi ; You, Xin
Abstract:
Background:
More than half of neuroendocrine tumor (NET) patients will experience liver metastasis, and interventional therapy represented by transarterial embolization (TAE) is the main local treatment method. Surufatinib is recommended as a standard systemic treatment for advanced NETs. The efficacy and safety of surufatinib combined with TAE in the treatment of liver metastasis are undetermined. This study was conducted to compare the clinical outcome of surufatinib combined with TAE versus surufatinib monotherapy in liver metastatic NETs.
Methods:
This is a prospective, multicenter, open‐label, and randomized controlled trial. Patients diagnosed with liver metastatic NETs will be enrolled. Participants are randomly assigned in a 1:1 ratio to either the experimental group or the control group. Patients will be treated with surufatinib plus TAE in the experimental group, while patients in the control group will receive surufatinib monotherapy. The primary endpoint is progression‐free survival (PFS) assessed by a blinded independent image review committee (BIIRC). The secondary endpoints are investigator‐assessed PFS, liver‐specific objective response rate (ORR), objective response rate (ORR), disease control rate (DCR), overall survival (OS), and incidence of adverse events.
Discussion:
This is the first prospective study to investigate the efficacy of surufatinib combined with TAE. We expect this trial to propose a new and effective treatment strategy for liver metastatic NETs.
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 |
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 | |
| 胰腺继发性恶性肿瘤 | 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 | 晚期肝细胞癌 三线 | 二线 | 24 | Surufatinib + anti-PD-1/PD-L1 antibody | 繭廠淵築鏇願衊窪醖糧(選壓鏇獵鏇積觸鑰醖窪) = 夢齋膚餘範構膚製製壓 製積築壓積齋窪蓋鏇網 (簾築積鹹醖壓蓋網膚積 ) 更多 | 积极 | 2024-09-16 | |
繭廠淵築鏇願衊窪醖糧(選壓鏇獵鏇積觸鑰醖窪) = 醖製襯醖憲鬱膚蓋網觸 製積築壓積齋窪蓋鏇網 (簾築積鹹醖壓蓋網膚積 ) 更多 | |||||||
临床3期 | 29 | Surufatinib + TAE | 簾廠築觸願構襯衊壓構(襯選餘範築壓齋獵艱網) = not mature 築顧齋鬱糧鏇築蓋蓋築 (憲鬱艱餘遞膚窪繭襯構 ) 更多 | 积极 | 2024-09-16 | ||
临床2期 | 非鳞状非小细胞肺癌 二线 | 一线 | 74 | Surufatinib+toripalimab+pemetrexed+patinum (Naive advanced nsq-NSCLC pts without driver gene mutation) | 夢積選醖醖糧願憲鹹鹽(願獵糧願窪醖壓鏇獵鹽) = 憲糧窪築壓鹽鹽鬱鏇繭 願顧遞鬱範艱糧襯網顧 (糧衊衊簾選製淵衊齋衊, 3.5 ~ 17.3) 更多 | 积极 | 2024-09-14 | |
Surufatinib+toripalimab+pemetrexed+patinum (driver gene mutations failing with tyrosine kinase inhibitors) | 夢積選醖醖糧願憲鹹鹽(願獵糧願窪醖壓鏇獵鹽) = 築窪廠遞夢艱築鹹觸鹽 願顧遞鬱範艱糧襯網顧 (糧衊衊簾選製淵衊齋衊, 6.6 ~ 13.7) 更多 | ||||||
临床2期 | 25 | Surufatinib + Gemcitabine (STS failed to first-line anthracyclines chemotherapy) | 齋鬱齋鹽願淵遞遞築鹽(製鹽積築觸鬱願襯鹹夢) = 齋遞膚鹹願壓願蓋襯鹽 醖鏇餘網艱壓網積艱觸 (醖顧願鏇醖顧簾淵選憲 ) 更多 | 积极 | 2024-09-14 | ||
(failed with anlotinib) | 齋鬱齋鹽願淵遞遞築鹽(製鹽積築觸鬱願襯鹹夢) = 醖蓋選壓築積範窪觸襯 醖鏇餘網艱壓網積艱觸 (醖顧願鏇醖顧簾淵選憲 ) 更多 | ||||||
临床1/2期 | 130 | (Dose-Escalation Phase: Surufatinib 50 mg) | 醖願鑰構願鹹簾齋網淵(選淵網鹹積襯遞膚膚衊) = 繭築衊淵鹹膚壓餘積鬱 遞獵淵夢糧鏇鹽鏇廠淵 (艱顧選醖鑰窪獵網蓋廠, 淵鹽範範夢窪觸遞網廠 ~ 衊觸鏇艱獵網窪積壓壓) 更多 | - | 2024-07-10 | ||
(Dose-Escalation Phase: Surufatinib 100 mg) | 醖願鑰構願鹹簾齋網淵(選淵網鹹積襯遞膚膚衊) = 餘醖繭願鑰獵糧壓積糧 遞獵淵夢糧鏇鹽鏇廠淵 (艱顧選醖鑰窪獵網蓋廠, 鹽顧積衊願遞窪蓋獵遞 ~ 蓋齋製襯鹹餘衊願壓窪) 更多 | ||||||
临床2期 | 56 | Surufatinib plus mFOLFOX6/FOLFIRI | 鹹膚膚製願醖膚範糧繭(餘築顧構製糧製襯繭繭) = 艱壓構選憲鏇衊齋衊鑰 製積憲廠鏇糧鏇獵衊構 (艱網鹹範衊顧獵繭衊憲 ) 更多 | 积极 | 2024-06-27 | ||
Surufatinib plus FOLFOXIRI | 鹹膚膚製願醖膚範糧繭(餘築顧構製糧製襯繭繭) = 繭鏇窪網醖簾餘遞憲醖 製積憲廠鏇糧鏇獵衊構 (艱網鹹範衊顧獵繭衊憲 ) 更多 | ||||||
临床2期 | 转移性结直肠癌 二线 | 29 | Surufatinib+mFOLFOX6/FOLFIRI | 簾憲鬱窪鑰醖淵範觸選(網簾獵鏇醖憲繭壓鏇範) = 鹽窪選觸衊獵糧醖餘製 顧窪觸糧繭鹽簾餘築壓 (艱積艱夢繭衊顧醖憲鏇 ) 更多 | 积极 | 2024-06-20 | |
Surufatinib+FOLFOXIRI | 簾憲鬱窪鑰醖淵範觸選(網簾獵鏇醖憲繭壓鏇範) = 廠範鹹鬱繭鏇網憲遞醖 顧窪觸糧繭鹽簾餘築壓 (艱積艱夢繭衊顧醖憲鏇 ) 更多 | ||||||
临床2期 | 广泛期小细胞肺癌 一线 | 维持 | 21 | Surufatinib + PD-1/L1 inhibitors | 鏇繭餘餘遞繭範築簾顧(鏇廠膚鏇鹽鏇簾鬱鑰鹹) = 範選鹹鬱築獵膚憲鹽繭 積蓋廠鬱構築淵製簾遞 (膚壓膚範艱蓋觸觸餘觸, 2.0 ~ 5.6) 更多 | 积极 | 2024-05-24 | |
临床1/2期 | 30 | 繭艱衊鹹築鬱鹹積構鑰(餘鏇網網觸醖餘壓齋糧) = 鬱範範襯簾壓網製遞鏇 積鑰願艱積觸範憲蓋積 (鏇鹹鏇鬱遞築糧醖淵築, 14.7 ~ 49.4) 更多 | 积极 | 2024-05-24 | |||
(RAS/BRAF mutations) | 繭艱衊鹹築鬱鹹積構鑰(餘鏇網網觸醖餘壓齋糧) = 淵艱鑰襯鹹構顧獵觸憲 積鑰願艱積觸範憲蓋積 (鏇鹹鏇鬱遞築糧醖淵築 ) 更多 | ||||||
临床2期 | 晚期非小细胞肺癌 三线 | 44 | Surufatinib+Vinorelbine (cohort 1) | 網繭鹽網淵簾網齋積襯(衊鬱顧鹽積淵鏇觸餘構) = 築齋憲鹽製壓網範廠鏇 構淵餘窪選餘醖觸鹽鏇 (選蓋構簾鑰繭鬱選夢蓋 ) 更多 | 积极 | 2024-05-24 | |
(cohort 2) | 網繭鹽網淵簾網齋積襯(衊鬱顧鹽積淵鏇觸餘構) = 窪積獵鑰襯憲鹽糧積廠 構淵餘窪選餘醖觸鹽鏇 (選蓋構簾鑰繭鬱選夢蓋 ) 更多 |
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