This is a non-randomized, open label, single arm Phase II trial with a two-stage design with histologically-confirmed metastatic and/or recurrent epithelioid hemangioendothelioma requiring systemic treatment. nab-Sirolimus 100 mg/m2 will be administered as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle. The primary objective is to determine ORR by RECIST v1.1 of nab-sirolimus in patients with EHE who require systemic treatment.

开始日期2025-12-31

申办/合作机构

Sarcoma Alliance for Research through Collaboration

CTR20253602

/ Recruiting临床2期

评价注射用西罗莫司（白蛋白结合型）联合奥曲肽长效注射液在转移性胃肠胰神经内分泌瘤（GEP-NETs）患者中安全性和有效性的II/III期研究

II期主要目的：评价注射用西罗莫司（白蛋白结合型）联合奥曲肽长效注射液在转移性GEP-NETs患者中的安全性、有效性，确定RP3D；次要目的：评价注射用西罗莫司（白蛋白结合型）联合奥曲肽长效注射液在转移性GEP-NETs患者的初步抗肿瘤活性、PK特征、生物标志物与疗效的相关性。 III期主要目的：评价注射用西罗莫司（白蛋白结合型）联合奥曲肽长效注射液对比依维莫司在转移性GEP-NETs患者中的有效性；次要目的：评价注射用西罗莫司（白蛋白结合型）联合奥曲肽长效注射液对比依维莫司在转移性GEP-NETs患者中的安全性、PK特征、生物标志物与疗效的相关性。

开始日期2025-09-15

申办/合作机构

石药集团中奇制药技术（石家庄）有限公司

NCT06941142

/ Not yet recruiting临床1期

An Ib/III Study to Evaluate the Safety and Efficacy of Sirolimus（Albumin-bound）in Combination With Palbociclib and Fulvestrant in Patients With Advanced HR- Positive, HER2- Negative Breast Cancer

This study adopts multicenter/randomized trial design. It plans to enroll patients with HR- positive, HER2- negative advanced breast cancer who are resistant to (neo)adjuvant endocrine therapy. Dose-escalation and dose-expansion studies will be carried out to evaluate the safety, tolerability, and preliminary efficacy of sirolimus (albumin-bound) in combination with palbociclib and fulvestrant in this patient population.

开始日期2025-04-30

申办/合作机构

石药集团中奇制药技术（天津）有限公司

100 项与西罗莫司(白蛋白结合型) 相关的临床结果

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100 项与西罗莫司(白蛋白结合型) 相关的转化医学

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100 项与西罗莫司(白蛋白结合型) 相关的专利（医药）

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13,253

项与西罗莫司(白蛋白结合型) 相关的文献（医药）

2025-12-01·INFLAMMATION RESEARCH

Silencing aquaporin 1 inhibits autophagy to exert anti-rheumatoid arthritis effects in TNF-α-induced fibroblast-like synoviocytes and adjuvant-induced arthritis rats

Article

作者: Li, Rong ; Lv, Min ; Zhang, Man-Yu ; Huang, Yan ; Li, Ling-Ling ; Xu, Ze-Shan ; Cai, Li ; Gu, Sheng-Long ; Wang, Meng-Qing ; Zhou, Meng-Yuan

OBJECTIVE:

Fibroblast-like synoviocytes (FLS) are key players in rheumatoid arthritis (RA) by resisting apoptosis via increased autophagy. Elevated synovial aquaporin 1 (AQP1) affects RA FLS behaviors, but its relationship with FLS autophagy is unclear. We aim to clarify that silencing AQP1 inhibits autophagy to exert its anti-RA effects.

METHODS:

We studied the effects and mechanisms of AQP1 silencing on autophagy in TNF-α-induced RA FLS and examined the crucial role of autophagy inhibition in its impacts on RA FLS pathogenic behaviors. We explored whether silencing synovial AQP1 relieved rat adjuvant-induced arthritis (AIA) by reducing synovial autophagy.

RESULTS:

TNF-α stimulation increased AQP1 expression and autophagy levels in RA FLS, with a positive correlation between them. AQP1 silencing inhibited autophagy in TNF-α-stimulated RA FLS, along with suppressing proliferation, promoting apoptosis, and mitigating inflammation. Notably, the inhibitory effects of AQP1 silencing on RA FLS pathogenic behaviors were cancelled by autophagy activation with rapamycin (Rapa) but enhanced by autophagy inhibition using 3-Methyladenine. Mechanistically, silencing AQP1 enhanced the binding of Bcl-2 to Beclin1 by decreasing Beclin1-K63 ubiquitination, thus inhibiting RA FLS autophagy. In vivo, silencing synovial AQP1 relieved the severity and development of rat AIA, alongside reducing Ki67 expression, promoting apoptosis, and decreasing autophagy within AIA rat synovium. Expectedly, the Rapa co-administration nullified the anti-AIA effects of silencing synovial AQP1.

CONCLUSION:

These findings reveal that silencing AQP1 inhibits RA FLS pathogenic behaviors and attenuates rat AIA through autophagy inhibition. This study may help clarify the pathogenic role of AQP1 in enhancing autophagy during RA development.

2025-12-01·Biomaterials advances

An early rapamycin-releasing nerve wrap with dual function for nerve regeneration and adhesion prevention

Article

作者: Zeng, Qi ; Xu, Wu ; Shi, Xudong ; Li, Ruijun ; Zhao, Yuanyuan ; Kang, Shiqi ; Wang, Naiyu

Limited ability of nerve regeneration and the formation of nerve adhesions result to poor outcomes of peripheral nerve injury (PNI) following surgical nerve repair. Currently, there is no efficient therapy for the improvement of functional recovery after surgical repair. Rapamycin (Rapa) has been found useful for promoting nerve regeneration through removing cellular debris at the early stages after PNI. However, its lower oral bioavailability and significant adverse effects limit its clinical application. In this study, we developed a biocompatible nerve wrap based on biocompatible monomethoxy poly (ethylene glycol)-poly (lactic-co-glycolic acid) (mPEG-PLGA) for the local delivery of Rapa. The Rapa-mPEG-PLGA nerve wrap exhibited a rough surface and good hydrophilicity with strong mechanical strength. In vitro release studies revealed an initial rapid phase within the first 8 days, followed by a stable release about 10 days. The released Rapa remained its bioactivity to induce autophagy and promote cell migration. In a rat model of sciatic nerve transection and immediate repair, the implantation of Rapa-mPEG-PLGA nerve wrap significantly enhanced axonal regeneration and myelination. Furthermore, the nerve wraps effectively prevented the occurrence of nerve adhesions. Improved functional recovery was observed with Rapa-mPEG-PLGA membrane wrap post-surgery 4 weeks and 8 weeks. In summary, the Rapa-loaded mPEG-PLGA nerve wrap promoted nerve regeneration by releasing Rapa at the early stage after injury, and acted as a physical barrier to reduce nerve adhesions. This local dual-action strategy is a promising candidate for clinical translation in the treatment of PNI following surgical repair.

2025-12-01·REPRODUCTIVE TOXICOLOGY

Blocking T-type calcium channels disrupts spermatogenesis in vivo and adversely affects spermatocytes in vitro by impairing mitochondrial function and autophagic flux

Article

作者: Nie, Junyu ; Huang, Shiqin ; Chen, Hao ; Wang, Xiaorong ; Wang, Lei ; Pu, Liping ; Zhao, Xiuling ; Liu, Lin

T-type calcium channels are pivotal in spermatogenesis. To evaluate the molecular mechanisms by which T-type calcium channels regulate spermatogenesis, we constructed animal and cellular models using T-type calcium channel inhibitor flunarizine (FNZ). Intraperitoneal administration of FNZ (30 mg/kg) significantly impaired sperm motility, inhibited testicular germ cell proliferation, and disrupted sperm mitochondrial function in male mice. FNZ, at concentrations of 7.5 μM, 15 μM, and 30 μM, significantly inhibited mouse spermatocyte (GC-2) cells proliferation. The detrimental effects of FNZ were mediated through the disruption of calcium homeostasis, mitochondrial dysfunction, and the induction of apoptosis. Moreover, FNZ exposure resulted in the accumulation of autophagosomes and an upregulation of P62 protein, which is implicated in autophagic degradation. Notably, the autophagy activator Rapamycin (Rapa) was found to mitigate FNZ-induced cellular damage in GC-2 cells by enhancing autophagy process. Conversely, chloroquine (CQ), an autophagy inhibitor that disrupts lysosomal degradation, corroborated the role of FNZ in autophagy modulation. Our results indicate that FNZ induces mitochondrial damage, impairs sperm motility and spermatocyte proliferation, and is accompanied by obstacles to autophagic flux.

124

项与西罗莫司(白蛋白结合型) 相关的新闻（医药）

2025-11-18

·国际肿瘤医讯

【mTOR抑制剂免费招募】新一代靶向药西罗莫司终于启动临床，正急招胃肠胰神经内分泌瘤患者！

西罗莫司（sirolimus）又称为雷帕霉素，是一种常用的特异性mTOR抑制剂。mTOR是一类丝/苏氨酸激酶，细胞内存在mTORC1和mTORC2两种复合体，其信号通路的稳定性会影响T细胞中细胞因子的表达，并参与免疫抑制，影响DNA转录，调节细胞的生长与凋亡。如今，这款抗癌新药终于正式启动临床了！国内患者现可通过全球肿瘤医生网医学部（4006667998），了解详细的入排标准，或初步评估是否符合参加资格。抗癌项目简介药品名称：西罗莫司（白蛋白结合型）联合奥曲肽长效注射液；分期：Ⅱ期、Ⅲ期；治疗线数：一线治疗失败；突变基因：mTOR。适合哪些患者？适用于胃肠胰神经内分泌瘤。入选标准（部分）受试者必须符合以下所有标准，方可进入本研究： 1）18 岁以上，男女不限； 2）经组织学确诊的不可切除的局部晚期或转移性胃肠胰 G1/G2 神经内分泌瘤（GEP-NETs），根据 2019 年 WHO 组织学分级标准；既往未接受过神经内分泌瘤的系统性抗肿瘤治疗； 3）具有预后不良因素（即 Ki-67 为 5% ~20%，或 Ki-67 < 5%伴肝转移瘤负荷≥25%）； 4）需为无激素相关症状的非功能性 GEP-NETs； 5）至少有 1 个符合 RECIST V1.1 标准的可测量病灶。排除标准（部分）受试者必须符合以下所有标准，方可进入本研究： 1）有不受控制/严重腹泻，或入组时体温高于 38.0℃； 2）在首次给药前 4 周内接受过其它未上市的临床研究药物治疗； 3）在首次给药前 4 周内进行过大型外科手术，且患者尚未充分恢复，包括伤口愈合不良等，或预估试验治疗期间将进行大型手术的患者； 4）在首次给药前 2 周内接受过全身使用的糖皮质激素（强的松＞10mg/天或等效剂量的同类药物）或其他免疫抑制剂治疗［除外以下情况：使用局部、眼部、关节腔内、鼻内和吸入型糖皮质激素治疗；短期使用糖皮质激素进行预防治疗（例如预防造影剂过敏）］； 5）在首次给药前 2 周内有感染，且需要全身抗感染治疗（无并发症的尿路感染或上呼吸道感染除外）； 6）在首次使用研究药物前 4 周内使用过灭活疫苗或减毒活疫苗或新型冠状病毒疫苗；项目开展地区该研究目前在以下地区开展：上海、内蒙古、浙江、吉林、福建、四川、江苏、山西、山东、湖南、黑龙江、广东等地，具体情况以后期咨询为准。需提交的资料汇总患者需要准备和提交的资料包括：病理报告、基因检测报告、入院记录、出院小结、CT/MRI检查、血常规、肝肾功能、凝血功能、传染病检查、心电图报告等。全球肿瘤医学部温馨提示如果您想参加该项临床研究，或想了解西罗莫司的更多讯息，可联系全球肿瘤医生网医学部（400-666-7998），获取国内外应用的更多讯息，或直接进行申请。我们承诺对所有受试者的个人信息保密，并保证在整个过程中，遵循国家临床研究相关的法律法规。 # “方舟基因宝藏计划“由全球肿瘤医生网联合无癌家园、权威基因检测机构、国际药厂、知名肿瘤中心发起的基因“寻宝”行动。本计划旨在深度挖掘每一份基因检测报告提示的生存希望，为肿瘤患者全面解读基因检测报告，并在全球范围内为肿瘤患者匹配适合的上市新药和在研药物临床试验，为患者找到新的生存机遇和上市新药及未上市新药免费治疗的机会！想参加的病友可以将基因检测报告，诊断报告电子版或拍照发送至：doctor.huang@globecancer.com邮件中留下联系方式，医学部收到报告分析完毕后1个工作日内电话联系；或直接致电全球肿瘤医生网医学部（400-666-7998）评估。本文为全球肿瘤医生网原创，未经授权严禁转载扫描添加病友群抗癌资讯｜新技术｜新药研发｜权威专家入群免费领取抗癌资料患者关心

2025-10-15

·米内网

【瞩目】石药1类新药大爆发，1款报产、5款获批临床

精彩内容近日，石药集团1类新药喜讯频传：依达格鲁肽α注射液申报NDA获受理，拟用于超重或肥胖等体重管理；SYS6010、SYS6043、DP303c注射液、SYS6002和注射用JSKN003获批IND，均拟用于治疗实体瘤。米内网数据显示，消化系统及代谢生物药、抗肿瘤和免疫调节剂生物药2025H1在中国三大终端六大市场销售额分别超190亿元和570亿元。石药集团部分1类新药审评进度来源：CDE官网，米内网整理依达格鲁肽α注射液是一款重组人源胰高血糖素样肽-1(hGLP-1)Fc融合蛋白注射液，可在控制饮食和增加运动的基础上，用于超重或肥胖成人的长期体重管理，目前该适应症已申报上市获受理。此外，该新药拟用于2型糖尿病的两项Ⅲ期临床试验正积极推进中。 SYS6010（EGFR ADC）、SYS6043（B7-H3 ADC）、DP303c注射液（HER2 ADC）和SYS600（ROR1 ADC）均可用于联合注射用西罗莫司（白蛋白结合型）治疗晚期实体瘤，注射用JSKN003（HER2双抗ADC）可单药或联合注射用多西他赛（白蛋白结合型）或联合其他用于乳腺癌新辅助治疗。5款新药均于近日获得临床试验默示许可。在中国三大终端六大市场（统计范围详见本文末），消化系统及代谢生物药、抗肿瘤和免疫调节剂生物药2024年销售额分别在350亿元和1000亿元以上，2025H1各以8.67%和12.77%的增速增长至超190亿元和570亿元。消化系统及代谢生物药、抗肿瘤和免疫调节剂生物药销售趋势（单位：万元）来源：米内网格局数据库近年来，石药集团持续加大研发投入，不断加快创新转型步伐。其中1类创新药方面（不含预防用生物药，下同），2025年至今，集团已有2款新药申报上市，分别为安尼妥单抗注射液、依达格鲁肽α注射液；24款新品获批临床，涉及全身用抗感染药物、神经系统药物、抗肿瘤和免疫调节剂等多个治疗大类。石药集团今年以来获批临床的1类新药来源：米内网中国申报进度（MED）数据库 24款获批临床的新药中，从最高研发进度看，SYS6010（非小细胞肺癌）、注射用JSKN003（乳腺癌、卵巢癌）、SYHX1901片（银屑病）、重组人源化抗HER2双特异性抗体注射液（乳腺癌）、重组人源化抗表皮生长因子受体单抗注射液（结直肠癌、非小细胞肺癌）等已步入Ⅲ期临床，SYHA1813口服液（小细胞肺癌）正处Ⅱ/Ⅲ期临床阶段。资料来源：米内网数据库、CDE官网等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至10月15日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

抗体药物偶联物申请上市临床3期临床申请免疫疗法

2025-10-08

·ioncology

ESMO 2025丨一文汇总乳腺癌领域中国专家入选的壁报研究

点击蓝字，关注我们编者按：2025年欧洲肿瘤内科学会年会（ESMO 2025）将于10月17日至21日在德国柏林召开，作为肿瘤学界的年度盛典，ESMO每年都会吸引上万名世界各地的肿瘤学专家参与，为全球学者提供了良好的交流平台。日前，ESMO已公布大会常规摘要（含Oral、Mini Oral、Poster三类）和“突破性摘要”（Late-Breaking Abstract，LBA）标题。肿瘤瞭望特将目前乳腺癌领域入选的中国专家投稿壁报研究进行汇总，并诚邀您持续关注重磅研究进展！ Breast cancer, early stage （早期乳腺癌） 298P - Development and validation of a novel HER2RI assay for predicting the risk of recurrence and survival in Asian population with HER2-positive breast cancer 用于预测亚洲HER2阳性乳腺癌患者复发和生存风险的新型HER2RI检测方法的开发和验证讲者：Yi-Kun Kang (Beijing, China) 300P - TIME-HER: A Dynamic Predictive Model for Prognosis of HER2-Positive Early Breast Cancer after HER2-targeted Therapy TIME-HER：HER2靶向治疗后HER2阳性早期乳腺癌预后的动态预测模型讲者：Qingyao Shang (Beijing, China) 305P - Neoadjuvant pyrotinib and letrozole plus dalpiciclib for triple-positive breast cancer: three-year outcomes from the MUKDEN 01 study MUKDEN 01研究三年随访结果：吡咯替尼联合来曲唑及达尔西利新辅助治疗三阳性乳腺癌的疗效分析讲者：刘彩刚（中国医学大学附属盛京医院） 306P - Neoadjuvant SHR-A1811 with or without pyrotinib in HER2-positive breast cancer (MUKDEN 07): A multi-cohort, multicenter, phase II clinical trial MUKDEN 07研究：一项针对HER2阳性乳腺癌的多队列、多中心Ⅱ期临床试验，评估新辅助治疗中SHR-A1811联合或不联合吡咯替尼的疗效讲者：刘彩刚（中国医学大学附属盛京医院） 312P - Comparison of survival outcomes between neoadjuvant and adjuvant therapy in patients with T1c, lymph node-negative, and hormone receptor-negative breast cancer: a study based on the SEER database and a Chinese cohort T1c期、淋巴结阴性且激素受体阴性乳腺癌患者新辅助治疗与辅助治疗生存结局的对比研究：基于SEER数据库与中国队列的分析讲者：Shiyu Liang (Chengdu, China) 317P - Myeloprotection with Trilaciclib in Hormone Receptor (HR)-Negative early breast cancer receiving adjuvant therapy Trilaciclib在激素受体（HR）阴性早期乳腺癌辅助治疗中的骨髓保护作用讲者：Jiajia Huang (Guangzhou, China) 344P - Inadequate ovarian suppression in young premenopausal women with estrogen receptor-positive breast cancer on ovarian suppression therapy 接受卵巢功能抑制治疗的年轻绝经前雌激素受体阳性乳腺癌患者卵巢抑制不充分的现象讲者：Dar-Ren Chen (Changhua City, Taiwan) 348P - Ten-Year Outcomes of Epirubicin Plus Paclitaxel Versus Epirubicin and Cyclophosphamide Followed by Paclitaxel in Hormone Receptor–Positive, ERBB2-Negative, Node-Positive Breast Cancer: A Phase 3 Randomized Clinical Trial 表柔比星联合紫杉醇对比表柔比星联合环磷酰胺序贯紫杉醇治疗激素受体阳性、ERBB2阴性、淋巴结阳性乳腺癌的10年随访结局比较：一项3期随机临床试验讲者：Liuliu Quan (Beijing, China) 382P - A modern DCIS-IBC guide board for postoperative upgrading in ductal carcinoma in situ 导管原位癌术后升级为浸润性乳腺癌的现代风险评估指南框架讲者：Chenglong Duan (xian, China) 383P - Spatial transcriptomics reveals biological disparities in ipsilateral breast tumor recurrence after breast-conserving surgery 空间转录组学揭示保乳术后同侧乳腺肿瘤复发的生物学差异讲者：FEILIN QU (Shanghai, China) 385P - Is axillary intervention necessary for selected patients with cN0-1 breast cancer after neoadjuvant chemotherapy? 新辅助化疗后的cN0-1乳腺癌患者是否有必要进行腋窝干预？讲者：Yuhan Zhang (Xi'an, Shaanxi Province, China) 386P - The Innovative Lancet Technique for Breast-Conserving Oncoplastic Surgery in Small- to Medium-Sized Breasts with Tumors in the Lower Inner Quadrant: A Multicenter Retrospective Study (IOS Study) 针对中小乳房下内侧象限肿瘤的保乳整形手术创新Lancet技术：一项多中心回顾性研究（IOS研究）讲者：Wenjie Shi (Magdeburg, Germany) 389P - A Competing Risk Analysis Model to Explore the Impact of Postoperative Radiotherapy for Sentinel Lymph Node Micrometastases or ITCs in Female Breast Cancer 竞争风险分析模型探讨术后放疗对女性乳腺癌前哨淋巴结微转移或孤立肿瘤细胞（ITCs）的影响讲者：Yudong Zhou (xian, China) 391P - Application of Preoperative 3-dimensional Vascular Reconstruction Assessment in Preventing Ischemic Complications After Nipple-Sparing Mastectomy: A Randomized Controlled Trial 术前三维血管重建评估在预防保留乳头乳房切除术后缺血性并发症中的应用：一项随机对照试验讲者：Xiaoqi Zhang (Guangzhou, China) 398P - Patient-reported outcomes (PROs) with GnRHa as ovarian function suppression (OFS) treatment in pre-menopausal Chinese patients with hormone receptor-positive (HR+) early breast cancer (EBC): a real-world observational investigation GnRHa作为卵巢功能抑制（OFS）治疗绝经前激素受体阳性（HR+）早期乳腺癌（EBC）患者的患者报告结局（PROs）：一项真实世界观察性研究讲者：范蕾（复旦大学附属肿瘤医院） 403P - Axillary Lymph Node Dissection Offers No Survival Benefit in Breast Cancer Patients with Sentinel Lymph Node Micrometastases After Neoadjuvant Therapy 腋窝淋巴结清扫术对新辅助治疗后前哨淋巴结微转移的乳腺癌患者无生存获益讲者：Jianing Zhang (Xi'an, China) 414P - Prognostic Value of ER reduction rate between pre- and post- Neoadjuvant Chemotherapy in Patients with ER-Positive/HER2-Negative Breast Cancer 新辅助化疗前后ER降低率对ER阳性/ her2阴性乳腺癌患者的预后价值讲者：Shunyi Liu (Fuzhou, China) 416P - Diverse adjuvant treatment in triple-negative breast cancer patients with residual disease after neoadjuvant chemotherapy: A single center real-world study 新辅助化疗后残留病灶的三阴性乳腺癌患者的多样化辅助治疗：一项单中心真实世界研究讲者：Xi Chen (Beijing, China) 417P - Proteomic analysis of residual disease identifies potential prognostic biomarkers of triple-negative breast cancer after neoadjuvant chemotherapy 三阴性乳腺癌新辅助化疗后残留病灶的蛋白质组学分析确定潜在的预后生物标志物讲者：Xi Chen (Beijing, China) 418P - Impact of BRCAness Status on Prognosis and Chemotherapy Sensitivity in Non-pCR Triple-Negative Breast Cancer Patients After Neoadjuvant Treatment BRCA样状态对新辅助治疗后未达病理完全缓解（non-pCR）三阴性乳腺癌患者预后及化疗敏感性的影响讲者：Hangcheng Xu (Beijing, China) Breast cancer, locally advanced （局部晚期乳腺癌） 466P - Efficacy and Safety of JS105, a Selective Inhibitor of Mutant PI3Kα, in Patients with Advanced Cancer 选择性突变型PI3Kα抑制剂JS105在晚期癌症患者中的疗效与安全性研究讲者：闫敏（河南省肿瘤医院） 468P - The Clinical Significance and Prognostic Impact of stromal tumor infiltrating lymphocytes in HER2-Positive Breast Cancer: Including a Neoadjuvant Subgroup Analysis HER2阳性乳腺癌间质肿瘤浸润淋巴细胞的临床意义和预后影响：包括新辅助治疗亚组分析讲者：Yujing Chang (Chengdu, China) 470P - Neoadjuvant cadonilimab (anti-PD-1/CTLA-4 bispecific antibody) plus chemotherapy in early or locally advanced triple-negative breast cancer: supplementary biomarker analyses from CABIN trial 新辅助cadonilimab（抗pd -1/CTLA-4双特异性抗体）联合化疗治疗早期或局部晚期三阴性乳腺癌：来自CABIN试验的补充生物标志物分析讲者：TAO WU (Changde City, China) 472P - The mechanism and preclinical translational research of targeted inhibition of ATM enhancing the therapeutic efficacy of PD-1/PD-L1 inhibitors in triple-negative breast cancer by modulating CD8⁺T cells in the tumor immune microenvironment 靶向抑制ATM通过调控肿瘤免疫微环境中CD8⁺T细胞增强PD-1/PD-L1抑制剂治疗三阴性乳腺癌的机制及临床前转化研究讲者：Xiaojing Guo (Tianjin, China) 473P - Neoadjuvant Trilaciclib plus chemotherapy and anti-PD1-antibody for locally advanced triple-negative breast cancer: Preliminary short-term efficacy and safety results from a single-arm, multicenter, phase II trial 新辅助治疗中Trilaciclib联合化疗及抗PD-1抗体治疗局部晚期三阴性乳腺癌：一项单臂、多中心Ⅱ期试验的初步短期疗效与安全性结果讲者：Jiaxuan Liu (Beijing, China) 479P - H4K8la/CXCL10-driven M2 polarization via tumor cell-macrophage lactate feedback loop mediates doxorubicin resistance in TNBC H4K8la/CXCL10通过肿瘤细胞-巨噬细胞乳酸反馈回路驱动M2型巨噬细胞极化，介导三阴性乳腺癌对多柔比星的耐药性讲者：Qingqing Wang (Wuhan, China) Breast cancer, metastatic （转移性乳腺癌） 490P - Bireociclib plus Letrozole/Anastrozole versus Placebo plus Letrozole/Anastrozole for the Treatment of HR+/HER2- Advanced Breast Cancer: Interim Analysis of BRIGHT-3 study 吡洛西利联合来曲唑/阿那曲唑vs安慰剂联合来曲唑/阿那曲唑治疗HR+/HER2-晚期乳腺癌的比较：BRIGHT-3研究的期中分析讲者：张清媛（哈尔滨医科大学附属肿瘤医院） 495P - Safety and efficacy of nab-Sirolimus (HB1901) + endocrine therapy in HR+/HER2- advanced breast cancer after standard therapy failure: A multicenter, open-label, phase 2 study 白蛋白结合型西罗莫司（HB1901）联合内分泌治疗在标准治疗失败后的HR+/HER2-晚期乳腺癌中的安全性和有效性：一项多中心、开放标签、II期研究讲者：马飞（中国医学科学院肿瘤医院） 501P - Efficacy and Safety Outcomes across Young to Older Age Groups of Patients with HR+/HER2- Advanced Breast Cancer Treated with Bireociclib plus Endocrine Therapy: a Pooled Analysis of BRIGHT Studies 吡洛西利联合内分泌治疗HR+/HER2-晚期乳腺癌年轻和老年患者的疗效和安全性结局：BRIGHT研究的汇总分析讲者：张清媛（哈尔滨医科大学附属肿瘤医院） 505P - Safety and Preliminary Efficacy of a Novel CDK2/4 Inhibitor TYK-00540 in Patients with Advanced Solid Tumors: Results from a Phase I Dose-Escalation Study 新型CDK2/4抑制剂TYK-00540用于晚期实体瘤患者的安全性和初步疗效：来自1期剂量递增研究的结果讲者：孟艳春（复旦大学附属肿瘤医院） 509P - A Phase II Trial of Anlotinib and Fulvestrant in Patients with HR-Positive and HER2-Negative, Secondary Hormone Resistant, Metastatic Breast Cancer 安罗替尼+氟维司群治疗HR+/HER2-继发性激素抵抗性转移性乳腺癌患者的2期试验讲者：王晓稼（浙江省肿瘤医院） 513P - TY-302，a CDK4/6 inhibitor (CDK4/6i), combined with toremifene in patients with advanced solid tumors: Results from a phase Ia/Ib study. CDK4/6抑制剂（CDK4/6i）TY-302联合托瑞米芬治疗晚期实体瘤：Ia/Ib期研究结果讲者：马飞（中国医学科学院肿瘤医院） 518P - Efficacy and Safety of Treatments in HR+HER2- Advanced Breast Cancer After Cyclin-Dependent Kinase 4/6 inhibitors progression: A Network Meta-Analysis and Scoping Review CDK4/6抑制剂治疗进展后HR+/HER2-晚期乳腺癌治疗的疗效和安全性：一项网状meta分析和范围综述讲者：佟仲生（天津医科大学肿瘤医院） 525P - Efficacy and Safety of Post-CDK4/6 Inhibitor Treatment Options for HR-Positive, HER2-Negative Advanced Breast Cancer: A Network Meta-Analysis of Randomized Controlled Trials CDK4/6抑制剂后治疗方案对HR+/HER2阴-晚期乳腺癌的疗效和安全性：一项随机对照试验的网络荟萃分析讲者：Junxiao Wang (Fuzhou, China) 529P - PIK3CA Mutation Profiles in Primary and Metastatic Lesions in Chinese Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer 中国激素受体阳性、HER2阴性乳腺癌患者原发性和转移性病灶中PIK3CA的突变谱讲者：徐贵颖（吉林省肿瘤医院） 538P - Preliminary efficacy and safety of TQB2102 in patients with HER2 positive Recurrent/Metastatic Breast Cancer: Results from a phase Ib study TQB2102治疗HER2阳性复发/转移性乳腺癌患者的初步疗效和安全性：一项Ib期研究的结果讲者：张清媛（哈尔滨医科大学附属肿瘤医院） 545P - A Retrospective Multicenter Cohort Study on the Efficacy and Safety of Inetetamab and Pyrotinib Combined with Chemotherapy (IPyC) for HER2+ Metastatic Breast Cancer 伊尼妥单抗+吡咯替尼联合化疗（IPyC）治疗HER2+转移性乳腺癌的疗效和安全性回顾性多中心队列研究讲者：Wu Fan (Fuzhou, China) 546P - Efficacy and safety of Pyrotinib-based therapy after prior trastuzumab and pertuzumab in HER2-positive metastatic breast cancer: a multicenter, retrospective, real-world study 既往曲妥珠单抗和帕妥珠单抗治疗HER2阳性转移性乳腺癌后，接受以吡咯替尼为基础的治疗的有效性和安全性：一项多中心、回顾性、真实世界研究讲者：王涛（解放军总医院第五医学中心） 549P - Phase I study of ARX788 plus toripalimab in advanced solid tumors with expansion in HER2-low advanced breast cancer. ARX788联合特瑞普利单抗治疗HER2低表达的晚期实体瘤的I期研究讲者：王晓稼（浙江省肿瘤医院） 551P - SHR-A1811 combined with Adebrelimab in HR-/HR-low, HER2-low metastatic breast cancer: Preliminary results from an open-label, single-arm, phase II Trial SHR-A1811联合阿得贝利单抗治疗HR-/HR低表达、HER2低表达的转移性乳腺癌：开放标签、单臂、II期试验的初步结果讲者：Jiaxuan Liu (Beijing, China) 552P - Phase I study data of a novel eribulin-based HER2 ADC: Safety and efficacy of SMP-656 in HER2-expressing solid tumor 基于艾立布林的新型HER2 ADC的 I期研究数据：SMP-656在HER2表达实体瘤中的安全性和疗效讲者：张剑（复旦大学附属肿瘤医院） 556P - Updated Efficacy of Anti-TROP2 ADC ESG401 for First-Line Metastatic TNBC 抗TROP2 ADC ESG401治疗一线转移性TNBC的最新疗效讲者：邱福铭（浙江大学医学院附属第二医院） 559P - SHR-A1921, a novel trophoblast cell-surface antigen 2 targeted antibody-drug conjugate, with or without adebrelimab in advanced triple-negative breast cancer (TNBC): data from two open-label, multicenter clinical trials SHR-A1921，一种新型靶向滋养层细胞表面抗原2的抗体药物偶联物，联合或不联合阿得贝利单抗（adebrelimab）治疗晚期三阴性乳腺癌（TNBC）：两项开放标签、多中心临床试验的数据讲者：史业辉（天津医科大学肿瘤医院） 564P - Combined PD-1 Inhibition and Chidamide in Metastatic Triple-Negative Breast Cancer: A Phase II Clinical Trial PD-1抑制联合西达本胺治疗转移性三阴性乳腺癌：一项II期临床试验讲者：Sifen Wang (Guangzhou, China) 571P - Adebrelimab plus Apatinib and Etoposide in the Treatment of HER2-Negative Breast Cancer Brain Metastasis: A Phase II Study 阿得贝利单抗联合阿帕替尼和依托泊苷治疗HER2阴性乳腺癌脑转移：一项II期研究讲者：王涛（解放军总医院第五医学中心） 581P - Improving Survival in Heavily Treated Metastatic Breast Cancer Through Personalized Chemotherapy Selection Using Ex Vivo Expanded Circulating Tumor Cells 通过使用体外扩增的循环肿瘤细胞进行个体化化疗选择来改善重度治疗的转移性乳腺癌患者的生存讲者：Wen-Ying Lin (Taipei City, Taiwan) 595P - Efficacy and Safety of Rivaroxaban Prophylaxis on Catheter-Related Thrombosis in Breast Cancer Patients Undergoing Chemotherapy with PICC: A Prospective Cohort Study 利伐沙班预防乳腺癌化疗患者PICC导管相关性血栓形成的有效性和安全性：一项前瞻性队列研究讲者：Die Sang (Beijing, China) 598P - An observational clinical study to evaluate the consistency of PIK3CA mutations in tumor tissues and corresponding plasma circulating tumor DNA (ctDNA) of patients with HR+ mBC 一项观察性临床研究，旨在评估HR+mBC患者肿瘤组织中PIK3CA突变和相应血浆循环肿瘤DNA（ctDNA）的一致性讲者：欧阳取长（湖南省肿瘤医院） 599P - Efficacy and Safety of Dalpiciclib Combined with Endocrine Therapy After Progression on Prior CDK4/6 Inhibitors in HR+/HER2- Advanced Breast Cancer 在既往CDK4/6抑制剂经治的HR+/HER2-晚期乳腺癌发生进展后，达尔西利联合内分泌治疗的疗效和安全性讲者：李俏（中国医学科学院肿瘤医院） 600P - Matching-Adjusted Indirect Comparison of Bireociclib Plus Fulvestrant versus Dalpiciclib Plus Fulvestrant as Second-Line Treatment of HR+/HER2- Advanced Breast Cancer (ABC) 通过匹配校正间接比较吡洛西利+氟维司群与达尔西利+氟维司群作为HR+/HER2-晚期乳腺癌二线治疗的疗效（ABC）讲者：王佳玉（中国医学科学院肿瘤医院） 602P - VMP1 inhibits the progression of breast cancer via regulating PI3K/AKT and MEK/ ERK signaling pathway VMP1通过调控PI3K/AKT和MEK/ ERK信号通路抑制乳腺癌的进展讲者：Shuzhao Chen (Guangzhou, China) 609P - Real-world Application of 18F-FES PET/CT on HR+ Breast Cancer Patients with Brain Metastases 18F-FES PET/CT在HR+乳腺癌脑转移患者中的实际应用讲者：王碧芸（复旦大学附属肿瘤医院） 612P - Impact of Rivaroxaban on Prophylaxis Against Catheter-Related Thrombosis in Breast Cancer Patients: A cohort study 利伐沙班对预防乳腺癌患者导管相关血栓形成的影响：一项队列研究讲者：Yurong Zhang (Beijing, China) 625TiP - A Multicenter, Prospective, Cohort Study of Trop-2 ADC Combination Therapy for Advanced Triple-negative Breast Cancer Trop-2 ADC联合治疗晚期三阴性乳腺癌的多中心、前瞻性、队列研究讲者：郝春芳（天津医科大学肿瘤医院） 631eP - Real-world study on the efficacy and safety of Dalpiciclib in elderly patients with HR-positive, HER2-negative advanced breast cancer in the Xinjiang region 新疆地区老年HR+/HER2-晚期乳腺癌患者应用达尔西利疗效及安全性的真实世界研究讲者：Yan Li (Urumqi, China) 635eP - The necessity of adding anti-HER2 antibody to TKI in trastuzumab-resistant, HER2-positive ABC: a multicenter real-world study 曲妥珠单抗耐药的HER2阳性ABC患者中，TKI联合抗HER2抗体的必要性：一项多中心真实世界研究讲者：Ruixia Song (Beijing, China) 636eP - Real-world efficacy and safety of trastuzumab deruxtecan in HER2-positive and HER2-low metastatic breast cancer: Evidence from a Chinese population T-DXd在HER2阳性和HER2低表达转移性乳腺癌中的真实疗效和安全性：来自中国人群的证据讲者：张剑（复旦大学附属肿瘤医院） 637eP - Clinical Outcomes and Safety of Sacituzumab Govetican in Chinese Metastatic HER2 Negative Breast Cancer Patients: A Real World Study SG治疗中国转移性HER2阴性乳腺癌患者的临床结局和安全性：一项真实世界研究讲者：Yuxin Mu (Shanghai, China) 638eP - Construction of an Efficacy Prediction Model for T-DXd Treatment of HER2-Positive and HER2-Negative Breast Cancer Based on Hematological Indicators: A Multicenter Real-World Study 基于血液学指标构建T-DXd治疗HER2阳性和HER2阴性乳腺癌疗效预测模型：一项多中心真实世界研究讲者：Yanfang Su (Beijing, China) 647eP - Efficacy and safety profiles of PARP inhibitors in Chinese patients with metastatic breast cancer: a multi-center real-world study PARP抑制剂治疗中国转移性乳腺癌患者的疗效和安全性：一项多中心真实世界研究讲者：Xuenan Peng (Beijing, China) 648eP - Analysis of efficacy and safety of eribulin in the treatment of advanced breast cancer in the real-world 艾立布林治疗晚期乳腺癌的真实世界疗效和安全性分析讲者：Xiao Chen (Shenzhen, China) 652eTiP - A Phase 1b/2 study of FWD1802, a novel oral estrogen receptor (ER) degrader (SERD), in combination with multiple CDK4/6 inhibitors (CDK4/6i) and mTOR inhibitor in ER+/HER2- advanced or metastatic breast cancer (a/m BC) FWD1802（一种新型口服ER降解剂）联合多种CDK4/6抑制剂（CDK4/6i）和mTOR抑制剂治疗ER+/HER2-晚期或转移性乳腺癌（A /m BC）的1b/2期研究讲者：孟艳春（复旦大学附属肿瘤医院） 653eTiP - Translational study and First-in-Human (FIH) study design of KH815, a novel dual-payload TROP-2 targeted Antibody-Drug Conjugate (ADC), in patients with advanced solid tumors KH815是一种新型双有效载荷靶向TROP-2的抗体-药物偶联物（ADC），用于晚期实体瘤患者的转化研究和首次入人（FIH）研究设计讲者：马飞（中国医学科学院肿瘤医院）（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果临床2期临床3期

100 项与西罗莫司(白蛋白结合型) 相关的药物交易

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
血管周围上皮样细胞肿瘤	美国	Aadi Subsidiary, Inc.	2021-11-22

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
HR阳性/HER2阴性乳腺癌	临床3期	中国	石药集团中奇制药技术（石家庄）有限公司	2025-05-09
HER2阳性转移性乳腺癌	临床3期	中国	石药集团中奇制药技术（天津）有限公司	2025-04-01
KRAS 突变的低级别浆液性卵巢癌	临床2期	美国	Whitehawk Therapeutics, Inc.	2024-12-26
复发性卵巢癌	临床2期	美国	Whitehawk Therapeutics, Inc.	2024-12-26
子宫内膜样癌	临床2期	美国	Whitehawk Therapeutics, Inc.	2023-12-28
复发性子宫内膜癌	临床2期	美国	Whitehawk Therapeutics, Inc.	2023-12-28
胃肠道神经内分泌肿瘤	临床2期	美国	Whitehawk Therapeutics, Inc.	2023-11-07
肺神经内分泌肿瘤	临床2期	美国	Whitehawk Therapeutics, Inc.	2023-11-07
胰腺神经内分泌肿瘤	临床2期	美国	Whitehawk Therapeutics, Inc.	2023-11-07
Leigh病	临床2期	-	Whitehawk Therapeutics, Inc.	2022-04-30

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05997017 (ESMO2025)	临床2期	复发性子宫内膜癌	24	IV nab-sirolimus + oral letrozole	夢簾顧製壓膚廠餘積顧(獵簾範夢襯衊襯廠範築) = 醖糧鏇構襯壓餘積齋遞鬱淵壓憲糧襯遞窪鬱選 (壓鬱構遞壓構齋築窪糧 ) 更多	积极	2025-10-17
NCT02494570 (AMPECT, PRNewswire) 人工标引	临床2期	血管周围上皮样细胞肿瘤	16	nab-Sirolimus	選鑰鹹壓膚獵夢獵繭範(遞淵鏇網範襯糧醖製繭) = 築獵網選衊壓廠憲顧鹹窪獵憲衊網積鬱繭鏇醖 (壓膚繭願鹹網餘襯壓築 ) 更多	积极	2024-03-17
NCT03660930 (CTgov)	临床1/2期	局部晚期软组织肉瘤 \| 转移性软组织肉瘤	19	Sirolimus Albumin-bound Nanoparticles+Pazopanib hydrochloride	夢簾衊觸築齋積膚遞憲 = 鹽餘糧夢選鹽醖窪選憲遞積艱觸鏇鑰鹽艱蓋夢 (製網廠網膚蓋醖網衊窪, 遞網築鹽鏇膚憲蓋願醖 ~ 遞襯糧獵餘衊鏇淵廠構) 更多	-	2024-03-13
NCT05103358 (PRECISION1, PRNewswire) 人工标引	临床2期	实体瘤 TSC1 Mutation (Inactivating) \| TSC2 Mutation (Inactivating)	40	nab-Sirolimus (inactivating alteration in TSC1)	餘糧廠窪鹹範鏇鑰觸鑰(衊憲築繭齋醖淵簾繭壓) = 齋獵廠糧遞範顧網選齋鹹積積獵範鏇願構鑰餘 (鑰築齋糧夢網淵積製獵 ) 更多	积极	2023-12-14
				nab-Sirolimus (inactivating alteration in TSC2)	餘糧廠窪鹹範鏇鑰觸鑰(衊憲築繭齋醖淵簾繭壓) = 壓艱簾獵襯鑰餘鹽襯鑰鹹積積獵範鏇願構鑰餘 (鑰築齋糧夢網淵積製獵 ) 更多
NCT04608448 (Topical-RAPA, CTgov)	早期临床1期	炎症	22	Rapamycin Topical Ointment (Topical Rapamycin)	醖獵糧鬱餘鏇廠顧衊餘(網築鑰窪膚簾範鏇繭鏇) = 艱網淵鬱選廠窪願蓋選淵廠淵鏇蓋積憲淵廠鏇 (鏇憲觸簾鬱淵糧窪顧獵, 願簾餘窪積襯鏇膚淵餘 ~ 憲範願襯築築蓋膚簾壓) 更多	-	2023-07-19
				Placebo (Placebo)	醖獵糧鬱餘鏇廠顧衊餘(網築鑰窪膚簾範鏇繭鏇) = 選蓋鹹膚範簾憲選壓網淵廠淵鏇蓋積憲淵廠鏇 (鏇憲觸簾鬱淵糧窪顧獵, 構衊齋襯淵窪範餘顧窪 ~ 淵憲選餘願觸衊築鹹選) 更多
NCT03660930 (ASCO 12023 \| ASCO 22023) 人工标引	临床1期	局部晚期软组织肉瘤	19	Pazopanib+ABI-009	範糧獵夢簾鬱蓋襯網鏇(廠鏇夢艱窪艱鏇鹽網選) = NAB-S 30 mg/m2 day 1 and PAZO 400 mg days 1-21 顧蓋積鹹廠遞遞艱選餘 (繭窪窪築範衊積鹹鬱糧 ) 更多	积极	2023-05-26
NCT02494570 (AMPECT, AACR2023) 人工标引	临床2期	血管周围上皮样细胞肿瘤 TSC1 Mutation \| TSC2 Mutation \| pS6 Positive ... 更多	25	nab-Sirolimus (TSC1 or TSC2 inactivating alterations)	淵鏇廠鏇淵壓壓觸憲廠(構獵窪觸壓遞鹽積築壓) = 獵憲選鹹鏇醖鬱製繭廠襯齋廠糧餘範選鹽鏇構 (膚鹹願顧鬱鏇餘憲積選 ) 更多	积极	2023-04-14
				nab-Sirolimus (pS6 positive )	淵鏇廠鏇淵壓壓觸憲廠(構獵窪觸壓遞鹽積築壓) = 鹹積襯獵憲選齋鏇遞襯襯齋廠糧餘範選鹽鏇構 (膚鹹願顧鬱鏇餘憲積選 ) 更多
NCT02494570 (UPLIFT (ENGOT-ov67/GOG-3048) \| AMPECT, CTgov)	临床2期	血管周围上皮样细胞肿瘤	34	nab-Sirolimus	構艱顧願鹽鏇糧廠網網 = 繭醖壓願醖鏇艱觸鏇獵淵觸蓋夢範夢憲衊襯醖 (顧糧繭鬱糧醖憲鑰襯餘, 壓鹹簾鑰遞鬱淵網膚鬱 ~ 衊顧願鏇鏇獵簾膚壓壓) 更多	-	2023-04-07
NCT02975882 (ADVL1514, ASCO2022) 人工标引	临床1期	复发性实体肿瘤 \| 中枢神经系统肿瘤	32	temozolomide+irinotecan+ABI-009 (nab-sirolimus) (DL1)	窪夢襯鹽鏇獵膚遞齋糧(簾繭築廠範廠願繭齋鑰) = 選膚膚積築範窪鹽觸簾衊鑰網構膚壓膚糧鑰顧 (鏇範鏇顧範衊製鬱衊齋 )	积极	2022-06-02
				temozolomide+irinotecan+ABI-009 (nab-sirolimus) (DL-1)	窪夢襯鹽鏇獵膚遞齋糧(簾繭築廠範廠願繭齋鑰) = 獵觸鑰淵壓製壓齋觸窪衊鑰網構膚壓膚糧鑰顧 (鏇範鏇顧範衊製鬱衊齋 )
NCT03817515 \| NCT02494570 (AMPECT, ASCO2022) 人工标引	临床2期	血管周围上皮样细胞肿瘤	47	nab-Sirolimus (AMPECT)	鬱窪襯構選築餘壓鑰簾(製鹽觸簾醖範廠醖膚積) = 膚築製壓糧淵鬱鏇鬱觸糧衊選齋餘選齋艱夢餘 (窪鑰齋繭夢襯構淵願繭 ) 更多	积极	2022-06-02
				nab-Sirolimus (EAP)	築選獵膚鹹餘齋選鹹構(壓壓繭淵構蓋憲築窪鹽) = 鏇選膚窪膚顧積鹽鹽襯夢觸鏇簾窪築齋鑰願憲 (製廠積鹹鏇淵衊築廠艱 ) 更多