An Umbrella Ib/II Phase Study Evaluating the Efficacy and Safety of First-Line Combination Therapy in the Treatment of Extensive-Stage Small Cell Lung Cancer

This is an open-label umbrella study conducted in first treatment ES-SCLC patients, employing a novel umbrella trial design (biomarker-integrated multi-arm trial with a shared ICI+chemotherapy control arm). Eligible patients were assigned to trial arms based on biomarker expression levels. Biomarker subgroups were defined as: (1) High ASCL1/NEUROD1/DLL3 expression: DLL3-CAR-NK cells combined with ICI + etoposide + carboplatin (DLL3 group); (2) Myc overexpression: XPO1 inhibitor selinexor combined with ICI + etoposide + carboplatin (XPO1 group); (3) VIM/AXL high expression group treated with anlotinib combined with ICI + etoposide + carboplatin (anlotinib group).

开始日期2025-11-01

申办/合作机构

天津市肿瘤医院（天津医科大学肿瘤医院）

NCT07193186

/ Not yet recruiting临床2期IIT

A Phase II Study of Anlotinib and Benmelstobart as Second-line Treatment in Locally Advanced or Metastatic Differentiated Thyroid Cancer

This study is a multicenter, open-label, phase II study to evaluate the efficacy and safety of Benmelstobart in combination with Anlotinib as a second-line treatment for locally advanced or metastatic differentiated thyroid cancer. Patients who meet the inclusion criteria and do not meet the exclusion criteria will receive Benmelstobart (1200mg, d1, q3w) in combination with Anlotinib (12mg, qd, d1-14, q3w). Treatment will continue until disease progression, voluntary withdrawal of informed consent, intolerable toxicity, or until the investigator determines that the patient no longer benefits. For locally advanced patients, if the disease converts from unresectable or borderline unresectable to resectable after treatment, surgical intervention will be performed.

开始日期2025-10-01

申办/合作机构

复旦大学

NCT07205185

/ Not yet recruiting临床2期IIT

A Multicenter, Single-arm, Prospective Phase II Clinical Study of Epalrotokewali Monotherapy Combined With Eribulin, Anlotinib, and Radiotherapy for the Treatment of Patients With Advanced Soft Tissue Sarcoma.

This study intends to enroll patients with advanced soft tissue sarcoma, employing immunotherapy combined with eribulin, anlotinib, and radiotherapy as subsequent-line treatment to preliminarily explore its efficacy and safety. QL1706, a dual-targeting agent against PD-1 and CTLA-4, has been approved by the National Medical Products Administration (NMPA) of China for the second-line treatment of cervical cancer.

开始日期2025-10-01

申办/合作机构

复旦大学

100 项与盐酸安罗替尼相关的临床结果

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100 项与盐酸安罗替尼相关的转化医学

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100 项与盐酸安罗替尼相关的专利（医药）

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1,214

项与盐酸安罗替尼相关的文献（医药）

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of first-line treatment for advanced soft tissue sarcomas in China

Article

作者: Guan, Xin ; Liu, Yadi ; Li, Hongchao ; Zhao, Xincai ; Guo, Cheng ; Zhang, Jianping ; Xu, Rong ; Liang, Yifang

OBJECTIVES:

To evaluate the cost-effectiveness of four first-line treatment strategies-anlotinib, pazopanib, regorafenib, and conventional chemotherapy-for patients with advanced soft tissue sarcomas (STSs) in China.

METHODS:

A partitioned survival model was developed to simulate costs and quality-adjusted life years (QALYs) over a lifetime horizon from the Chinese healthcare system perspective. Relative treatment efficacies were derived from a network meta-analysis (NMA). Costs, sourced from local databases, and health utilities, obtained from the Sarcoma Treatment and Burden of Illness in North America and Europe (SABINE) study, were incorporated. A series of sensitivity and scenario analyses were performed to assess model robustness.

RESULTS:

In the base-case analysis, the outcomes were as follows: chemotherapy yielded 0.76 QALYs at a cost of 76,052 CNY; pazopanib yielded 0.74 QALYs at 108,790 CNY; regorafenib yielded 0.79 QALYs at 113,500 CNY; and anlotinib yielded 0.73 QALYs at 81,812 CNY. The incremental cost-effectiveness ratio (ICER) for regorafenib relative to chemotherapy was 1,738,024 CNY per QALY gained, substantially exceeding China's willingness-to-pay (WTP) threshold. Sensitivity analyses confirmed the robustness of these findings.

CONCLUSIONS:

Conventional chemotherapy, specifically using doxorubicin injection, represents the most cost-effective first-line treatment for advanced STS. However, this conclusion is sensitive to the chemotherapy composition; if the more expensive liposomal doxorubicin is used, anlotinib emerges as the preferred cost-effective option.

2025-12-31·Future Science OA

Real-world efficacy and safety of anlotinib combined with chemotherapy for advanced pancreatic cancer: a retrospective study

Article

作者: Gan, Hexia ; Zhang, Xiuping ; Wang, Zhiming ; Cheng, Lisha ; Li, Zhiyong ; Shen, Feng

BACKGROUND:

Pancreatic cancer (PC) is often diagnosed at advanced stages, limiting surgical options. There is no standardized treatment for second-line or beyond therapies, necessitating alternative treatments. This study evaluates the efficacy and safety of anlotinib combined with chemotherapy in advanced PC patients receiving second-line or subsequent treatments.

METHODS:

A retrospective analysis of 68 advanced PC patients was conducted. Twenty-six patients treated with anlotinib and chemotherapy were compared to 42 controls who received chemotherapy only. Demographic data, efficacy, survival, and adverse reactions were analyzed.

RESULTS:

In the anlotinib group, the therapeutic responses were as follows: Complete Response: 0, Partial Response: 2 (7.7%), Stable Disease: 13 (50.0%), and Progressive Disease: 11 (42.3%), the Objective Remission Rate was 7.7%, and the Disease Control Rate was 57.7%. The median Progression-Free Survival was 4.5 months. The Overall Survival was significantly longer in the anlotinib group compared to controls. Common adverse reactions included fatigue, bone marrow suppression, and hypertension, mostly grade 1-3. The potential toxicity and cumulative toxicity of long-term use is hand-foot syndrome, hypothyroidism and hypertension.

CONCLUSION:

The data generated suggest that anlotinib combined with chemotherapy may be an effective and tolerable option for second-line and subsequent treatment of advanced PC.

2025-12-31·ANNALS OF MEDICINE

The efficacy and safety of anlotinib plus PD-1 inhibitor in locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) patients who progressed on prior immune checkpoint inhibitors (ICIs): a retrospective real-world study (NCT 04984096)

Article

作者: Zhang, Ming ; Yu, Wen ; Ma, Xiumei ; Liu, Jun ; Li, Zhigang ; Zhu, Xueru ; Zhao, Lei ; Cheng, Yan ; Fu, Xiaolong ; Li, Hongxuan ; Feng, Wen ; Wu, Jianguo

BACKGROUND:

Several studies have shown that combining immune checkpoint inhibitors (ICIs) with antiangiogenic tyrosine kinase inhibitors is effective for solid tumors, including esophageal squamous cell carcinoma (ESCC). However, most of these studies were focused on immunotherapy-naive patients. This retrospective real-world study offers insights into the efficacy and safety of combining anlotinib with ICIs in locally advanced/metastatic ESCC patients who progressed on prior ICI.

METHODS:

We retrospectively analyzed the efficacy and safety of anlotinib plus PD-1 inhibitor in locally advanced/metastatic ESCC patients who had progressed on PD-1 inhibitor. Efficacy was assessed according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). The primary endpoints were the objective response rate (ORR) and disease control rate (DCR), while secondary endpoints were safety, overall survival (OS) and progression-free survival (PFS). Baseline characteristics and adverse events (AEs) were documented throughout the study.

RESULTS:

Between July 2020 and March 2022, 29 eligible patients were included in the final analysis, with 23 (79.3%) having previously undergone resection for ESCC. Of these 29 patients, 8 (27.6%) received first-line systemic therapy, 20 (69.0%) received second-line therapy, and 1 patient (3%) received third-line therapy. At the data cutoff, the ORR was 31.0%, and the DCR was 86.2%, with 9 patients achieving partial response (PR), 16 patients with stable disease (SD) and 4 patients with disease progression (PD). The median PFS was 5.33 months (95% CI: 4.28-6.38), and the median OS was 10.37 months (95% CI: 6.26-14.46). All patients experienced treatment-related adverse events (TRAEs), with anemia and lymphopenia being the most common. Only 2 patients (6.9%) experiencing grade 3-4 lymphopenia. All AEs were managed with symptomatic treatment and no treatment-related deaths occurred.

CONCLUSION:

The combination of anlotinib and a PD-1 inhibitor demonstrated promising antitumor efficacy and manageable toxicity in patients with locally advanced/metastatic ESCC who progressed on prior ICI. This regimen represents a feasible and well-tolerated treatment option for this patient population.

TRIAL REGISTRATION NUMBER:

NCT04984096.

807

项与盐酸安罗替尼相关的新闻（医药）

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

2025-10-05

·Biotech前瞻

小细胞肺癌治疗格局重塑：免疫联合、双抗登场与中国药企的集体突围

点击蓝字关注我们本期看点肺癌的分类，按照组织学，可以分为小细胞肺癌（13.9%）；非小细胞肺癌：鳞状细胞癌（24.4%）、腺癌（45.4%）、大细胞癌（1.5%）、其他（如腺鳞癌、肉瘤样癌等）。小细胞肺癌，相较于靶向治疗、免疫治疗进展迅速的非小细胞肺癌，小细胞肺癌一直都是临床难治性瘤种，但SCLC近年来逐步成为创新药物竞逐的热点。小细胞肺癌的治疗正在经历着变革，迎来了前所未有的快速发展时期，中国研究者做出了突出的贡献，掀起了小细胞肺癌诊疗研究领域的新浪潮。创新型抗肿瘤药物的研发和新的联合策略的探索将带给SCLC治疗格局日新月异的改变，随着分子机制的不断揭示，治疗脆弱点和预测标志物的络绎涌现，SCLC在迈向精准治疗的道路上更进一步，未来有望实现更大的突破。本期内容 01 首个ES-SCLC维持疗法获批 02 小细胞肺癌治疗现状和流行病学 03 国内小细胞肺癌在研态势 04 总结与展望【01 首个ES-SCLC维持疗法获批】 2025年10月3日，罗氏宣布美国FDA正式批准Tecentriq（阿替利珠单抗）及其皮下制剂联合靶向药芦比替定（lurbinectedin，商品名Zepzelca）用于广泛期小细胞肺癌（ES-SCLC）患者的一线维持治疗。适用人群为一线接受Tecentriq联合卡铂和依托泊苷（CE方案）诱导化疗后疾病未进展的成人患者。这一里程碑使Tecentriq+芦比替定成为首个也是目前唯一用于ES-SCLC一线维持治疗的组合方案，填补了小细胞肺癌诱导后治疗的空白。批准基于III期IMforte研究的卓越结果：与单用Tecentriq维持相比，Tecentriq+芦比替定将疾病进展或死亡风险降低了46%，将死亡风险降低了27%。在约3.2个月的诱导治疗后，联合方案的中位总生存期（OS）达到13.2个月，显著长于对照组的10.6个月（HR=0.73；95% CI：0.57–0.95；p=0.0174）；经独立评估的中位无进展生存期（PFS）也从2.1个月大幅延长至5.4个月（HR=0.54；95% CI：0.43–0.67；p<0.0001）。耶鲁癌症中心的Roy Herbst博士评价道：“对于广泛期小细胞肺癌患者及其家人来说，诱导治疗后的时期常常充满不确定性，因为复发风险很高。Tecentriq+芦比替定这一积极主动的维持方案提供了新选择，已证明可改善诱导治疗后病情未进展患者的PFS和OS，有望改变我们管理这种棘手疾病的方式，延缓疾病进展并延长生存”。罗氏首席医学官Levi Garraway也指出：“Tecentriq与芦比替定的组合将疾病进展或死亡风险降低近一半”，体现了罗氏与合作方Jazz公司致力于攻克顽固癌症的承诺。此次批准建立在Tecentriq在ES-SCLC中既有的基础之上——早在2019年，IMpower133研究证明Tecentriq联合化疗可使ES-SCLC患者获益，FDA据此批准了Tecentriq一线治疗，该方案也是当时二十年来针对该病的首个新疗法。如今Tecentriq+芦比替定维持进一步将一线疗效推上新高，为小细胞肺癌治疗开辟了全新局面。 02 小细胞肺癌治疗现状和流行病学小细胞肺癌（SCLC）是肺癌按组织学分类的一种，在肺癌中约占13–14%的比例。SCLC生物学行为极其凶险，增殖快、易广泛转移，患者五年生存率仅约5–10%。对于无法手术/放疗的广泛期患者，传统疗法长期局限于化疗，虽然初始反应率高但常在数月内复发。直到近年免疫疗法出现突破：罗氏的Tecentriq和阿斯利康的Imfinzi（度伐利尤单抗）先后在2019年获批与化疗联合用于ES-SCLC一线，使中位OS从纯化疗的约10个月提高到12.3和13个月左右。然而，即便加入PD-L1/PD-1抑制剂，广泛期患者预后提升仍有限，多数人在一年左右疾病进展。同时，相较于非小细胞肺癌在靶向治疗和免疫治疗领域的群星闪耀，SCLC过去几十年少有突破，一直被视为临床上难治的“贫瘠之地”。令人振奋的是，近几年小细胞肺癌治疗正经历前所未有的快速发展期。创新药物与新策略的涌现正在改写SCLC格局：从免疫治疗的新组合、抗肿瘤新靶点的发现，到新型药物技术（如双特异性抗体）的应用，都为这一顽疾带来转机。中国研究者在这一浪潮中贡献突出——不断有高水平临床研究在国内开展，并屡创佳绩。在2023年世界肺癌大会（WCLC）上，中国团队公布的ETER701 III期研究引发关注：该研究将本土研发的PD-L1单抗贝莫苏拜单抗（商品名安得卫®）与国产抗血管生成药物安罗替尼联合标准化疗用于ES-SCLC一线，结果中位PFS达到6.9个月，对照组仅4.2个月；中位OS更是高达19.3个月，对照组为11.9个月，刷新了国际注册研究的生存期记录。这一“四药方案”显著延长患者生存，在《Nature Medicine》在线发表。基于ETER701的优秀数据，NMPA已于2024年5月批准贝莫苏拜单抗联合安罗替尼及化疗用于ES-SCLC一线治疗，成为国内首个将免疫疗法与抗血管生成药物相结合的一线方案，为患者提供了全新选择。随着基础研究深入，SCLC的分子机制和亚型特征正逐步揭示，潜在的治疗靶点和预测生物标志物不断涌现，临床对此类创新策略的探索也全面提速。曾经“无药可治”的小细胞肺癌，正迎来从经验疗法走向精准治疗的新拐点。 03 国内小细胞肺癌在研态势普米斯丨PD-L1/VEGF双抗此外，其他国产双抗也纷纷布局小细胞肺癌，如普米斯的PD-L1/VEGF双抗PM8002。针对占肺癌病例14%的小细胞肺癌（SCLC），这款中国二期临床试验中展现突破性疗效的药物，已迈入全球三期临床阶段。数据显示，BNT327联合化疗为患者带来16.8个月的中位总生存期（OS），较当前罗氏Tecentriq（12.3个月）和阿斯利康Imfinzi（13个月）的标准疗法显著延长，有望重塑SCLC一线治疗格局。尽管跨试验对比存在局限性——BioNTech的48例单臂研究与跨国多中心数千人试验的样本差异引发讨论，但其二线治疗数据同样亮眼：65例患者中位OS达14.3个月，未接受免疫治疗人群的缓解持续时间（DOR）更长达11.5个月，超越安进同类药物Imdelltra（9.7个月）。目前，BNT327联合化疗的二线三期试验已在华启动，而全球布局则聚焦一线治疗，覆盖SCLC、非小细胞肺癌及三阴性乳腺癌三大癌种。正大天晴广泛期小细胞肺癌（ES-SCLC）一线治疗： 2024年5月，贝莫苏拜单抗注射液联合安罗替尼、依托泊苷及卡铂一线治疗ES-SCLC获国家药监局批准。在ETER701Ⅲ期研究中，接受该四药联合疗法的患者中位总生存期（OS）达19.3个月，较单纯化疗延长7.4个月，疗效数据亮眼。这是国内首个PD-L1抗体与安罗替尼联合用于ES-SCLC的一线疗法，为该类型患者提供了新的治疗选择。齐鲁制药丨PD-1/CTLA-4组合抗体 2025年2 月 11 日，药物临床试验登记与信息公示平台官网显示，齐鲁制药登记了一项 QL1706 注射液（艾帕洛利单抗/托沃瑞利单抗，PD-1/CTLA4 混合抗体）单药巩固治疗局限期小细胞肺癌的 III 期临床研究（CTR20250450）。在齐鲁艾托组合抗体肺癌、宫颈癌、结直肠癌、肝癌、食管癌数据汇总一文中就QL1706在各个实体瘤领域的研究进展进行过梳理。 04 总结与展望综上所述，小细胞肺癌正处于治疗变革的风口。一方面，以罗氏Tecentriq+芦比替定维持疗法为代表的国际新方案不断问世，为患者带来实实在在的生存获益。如前所述，该组合显著延长了一线治疗后的无进展间期和总生存，有望减少高复发风险患者的“休止期”焦虑。塔拉妥单抗等新型免疫疗法则填补了二线治疗的空白，让铂类化疗后进展的患者看到了长期生存的新希望。另一方面，中国本土的创新疗法崛起为这一领域注入强大动能。本土方案如贝莫苏拜单抗+安罗替尼联合化疗不但创造了19.3个月OS的历史新高，更证明了中国在SCLC临床研究上的实力和对全球的贡献。中外企业在小细胞肺癌领域的同台竞技，使患者有机会尽早用上更多元的疗法：从一线的免疫维持，到二线的靶向双抗，再到局限期巩固治疗，多条战线全面推进。可以预见，未来几年SCLC治疗将持续高速演进。全球范围内，PD-1/PD-L1抑制剂联合方案正向维持阶段延伸，DLL3等新靶点的开发也在向更早治疗线推进；国内则有望涌现更多“best-in-class”乃至“first-in-class”的新药。随着对SCLC分子分型和耐药机制认识的深入，更精准的治疗策略将逐步形成，包括针对特定亚型的靶向药物、免疫治疗敏感人群的生物标志物等。目前多项探索如免疫疗法联合ADC、新型疫苗疗法等也在进行中，期望进一步提高治疗效果。可以肯定的是，中外研发管线的百花齐放将加速这一顽疾的突破进程。在激烈的竞逐中，各种创新疗法互相验证、取长补短，最终受益的将是广大小细胞肺癌患者。或许在不久的将来，小细胞肺癌的管理将迎来质的飞跃——从过去束手无策的“绝症”，逐步转变为多种疗法可控的慢性疾病。对于每一位与病魔抗争的患者而言，这场中外合力推动的疗法革新，无疑带来了延长生命和改善生活质量的新曙光。 ★

免疫疗法临床3期临床结果

2025-10-04

·ioncology

CSCO 2025丨吴胤瑛教授深度解读神经内分泌瘤诊疗指南更新，破局副神经节瘤精准诊疗新纪元

编者按 2025年9月10日至14日，第28届中国临床肿瘤学会（CSCO）学术年会在山东济南顺利召开。作为我国肿瘤学领域最具影响力的学术盛会之一，本届年会聚焦肿瘤规范化诊疗、精准治疗及多学科协作等热点议题，涵盖多个瘤种的前沿进展与临床实践更新。在本次会议的神经内分泌肿瘤专场中，西安交通大学第一附属医院吴胤瑛教授围绕《CSCO神经内分泌肿瘤诊疗指南》中“副神经节瘤”部分的更新内容进行了深入解读，并就神经内分泌肿瘤的诊疗挑战、未来研究方向等话题接受了《肿瘤瞭望消化时讯》的专访。吴教授指出，随着分子分型、靶向治疗及核素治疗等技术的不断发展，神经内分泌肿瘤正逐步迈向精准化、个体化管理的新阶段。专家简介吴胤瑛教授西安交通大学第一附属医院副主任医师医学博士西安交通大学第一附属医院肿瘤内科 CSCO胆道肿瘤专家委员会常委 CSCO神经内分泌肿瘤专委会委员 CSCO青年专家委员会委员 CSCO结直肠专家委员会委员国家药品食品监督管理局临床试验现场数据核查专家中国抗癌协会肿瘤靶向治疗专业委员会青委会委员陕西省抗癌协会肿瘤生物治疗青年委员会主任委员陕西省抗癌协会神经内分泌肿瘤专业委员会副主任委员陕西省抗癌协会抗癌药物专业青年委员会副主任委员陕西省抗癌协会综合治疗专业青年委员会副主任委员肿瘤瞭望消化时讯：在本次CSCO神经内分泌肿瘤专场中，您重点解读了《CSCO神经内分泌肿瘤诊疗指南》中“副神经节瘤”部分的更新。能否请您分享一下这部分内容的主要亮点？这些更新对临床实践有何指导意义？吴胤瑛教授：在今年CSCO神经内分泌肿瘤专场中，CSCO专委会针对不同瘤种和部位开展了指南更新的初步意见征集。我主要负责汇报副神经节瘤/嗜铬细胞瘤(PPGL)部分的内容。副神经节瘤和嗜铬细胞瘤属于罕见且具有高度遗传倾向的神经内分泌肿瘤，约40%患者存在遗传倾向。本次指南更新的重点包括以下三方面： 1.强调遗传基因筛查的重要性，其主要目的在于明确致病原因，包括琥珀酸脱氢酶（SDH）基因突变家族及其它相关病理分型的变异。未来我们将在病理诊断方面做更多细化，依据不同分型选择相应药物治疗，并深入探索疾病的主要病因与发病机制。 2. 规范晚期不可切除或转移性PPGL的治疗策略。当前，在遗传性VHL综合征相关PPGL中，HIF-2α抑制剂Belzutifan已在全球获批应用于HIF突变患者的靶向治疗，指南未来或将其纳入靶向治疗推荐。 3. 细化酪氨酸激酶抑制剂（TKI）的应用。新版指南根据循证医学证据，对舒尼替尼、索凡替尼、安罗替尼等药物进行了优先级排序，为临床提供更明确的治疗路径。需强调的是，目前该指南仍处于初稿阶段，后续还将广泛征求临床医生的意见，预计将在今年底至明年初正式发布。肿瘤瞭望消化时讯：在多学科协作（MDT）模式下，神经内分泌肿瘤的诊疗为何特别需要包括核医学在内的多个专业共同参与？指南的制定对基层医疗实践有何重要意义？吴胤瑛教授：神经内分泌肿瘤具有高度异质性，因此在其诊疗过程中必须依赖多学科团队（MDT）协作，这涵盖了内科、外科、病理、影像及核医学等专业。在会议当天上午的神经内分泌肿瘤专委会学术会议中，议程安排也体现了这一理念，汇聚了来自不同学科的专家。更多学科的加入以及MDT团队的建立与规范化，旨在为神经内分泌肿瘤患者提供更加合理、规范且优质的治疗方案。同时，指南的制定也是为了为广大医务人员尤其是基层医生提供标准化诊疗的依据。肿瘤瞭望消化时讯：基于当前临床挑战和指南更新，您如何看待神经内分泌肿瘤未来的研究方向？您和团队目前重点关注哪些领域？吴胤瑛教授：在今年CSCO神经内分泌肿瘤专场中，我们不仅见证了指南的更新，还聆听了国内学者对最新研究进展的解读以及对未来发展趋势的展望。目前，神经内分泌肿瘤的治疗正呈现出多方面的进展。在外科领域，手术趋于微创化和精细化，例如微创手术、腔镜及机器人手术的应用日益广泛，对小肿瘤的主动监测策略也逐渐成熟。对于功能性肿瘤患者，手术的地位更为重要。在内科治疗方面，指南的更新体现出更细致的分层策略。以往针对转移性神经内分泌肿瘤的治疗推荐并未明确区分一线、二线及后线方案，而今年指南初稿中则对晚期疾病各线治疗进行了更系统划分，并对Ki-67指数作出更精细分级：除区分为G1和G2级之外，还将G2级进一步按Ki-67是否高于10%进行划分，同时明确NET G3与NEC的分类。这样的细化有助于实现更精准的治疗选择，改善患者临床结局，提高疗效并节约医疗资源。中国学者在神经内分泌肿瘤领域做出了众多贡献。我们团队在核医学治疗方面，特别是在肽受体放射性核素治疗（PRRT）领域，紧跟国内领先专家如徐建明教授的步伐，积极开展了多项研究。我中心作为西北地区唯一具备PRRT核药治疗能力的单位，依托平台优势与核医学科紧密合作，致力于开展更多原创性研究。在药物治疗方面，我们团队重点专注于NEC及NET G3患者的治疗优化，正积极开展化疗药物的优选研究，并系统收集西北地区这类患者的临床与流行病学资料。总之，从吴教授的专访内容中，我们可以预见，随着分子分型更精细、治疗手段更丰富、MDT协作更紧密，神经内分泌肿瘤将逐步摆脱“罕见而陌生”的标签。正如吴教授所言，"手术越来越小、用药越来越准、随访越来越长"——神经内分泌肿瘤正在从"罕见难治愈"迈向"可控、可管、可长期共存"的新阶段！（来源：肿瘤瞭望消化时讯）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。

CSCO会议

100 项与盐酸安罗替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XE	DB11885

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
转移性肾细胞癌	中国	正大天晴药业集团股份有限公司	2025-05-13
不可切除的肾细胞癌	中国	正大天晴药业集团股份有限公司	2025-05-13
子宫内膜癌	中国	正大天晴药业集团股份有限公司	2024-11-22
广泛期小细胞肺癌	中国	正大天晴药业集团股份有限公司	2024-05-08
分化型甲状腺癌	中国	正大天晴药业集团股份有限公司	2022-04-08
甲状腺髓样癌	中国	正大天晴药业集团股份有限公司	2021-01-30
小细胞肺癌	中国	正大天晴药业集团股份有限公司	2019-09-01
软组织肉瘤	中国	正大天晴药业集团股份有限公司	2019-07-01
非小细胞肺癌	中国	正大天晴药业集团股份有限公司	2018-05-14
局部晚期非小细胞肺癌	中国	正大天晴药业集团股份有限公司	2018-05-08
转移性非小细胞肺癌	中国	正大天晴药业集团股份有限公司	2018-05-08

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
肺泡软组织肉瘤	申请上市	中国	正大天晴药业集团股份有限公司	2025-08-23
晚期鳞状非小细胞肺癌	申请上市	中国	正大天晴药业集团股份有限公司	2025-04-23
非小细胞肺癌 III期	申请上市	中国	正大天晴药业集团股份有限公司	2025-04-23
肝细胞癌	申请上市	中国	正大天晴药业集团股份有限公司	2024-11-21
局限期小细胞肺癌	临床3期	中国	正大天晴药业集团股份有限公司	2024-09-01
原发性腹膜癌	临床3期	美国	南京爱德程宁欣药物研发有限公司	2022-04-06
原发性腹膜癌	临床3期	美国	正大天晴药业集团股份有限公司	2022-04-06
原发性腹膜癌	临床3期	中国	正大天晴药业集团股份有限公司	2022-04-06
原发性腹膜癌	临床3期	中国	南京爱德程宁欣药物研发有限公司	2022-04-06
原发性腹膜癌	临床3期	意大利	南京爱德程宁欣药物研发有限公司	2022-04-06

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临床结果

适应症

分期

评价

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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


NCT06348927 (WUKONG32, WCLC2025)	临床2期	晚期非小细胞肺癌一线 EGFR sensitive mutation (Ex19del, L858R)	16	Sunvozertinib+Anlotinib	簾構鬱衊願網夢願壓鹹(築簾齋繭製繭壓膚鑰鬱) = 繭夢構觸築憲簾醖襯醖壓鹽網繭鏇齋醖鑰夢膚 (壓鏇夢築鏇壓窪醖襯製 ) 更多	积极	2025-09-09
NCT05778149 (WCLC2025)	临床2期	晚期非小细胞肺癌一线 EGFR sensitive mutation (Ex19del, L858R),TP53 mutation	15	Anlotinib(12mgAnlotinib(12mg+orally QD+day 1 to 14 of a 21-day cycle)+Aumolertinib(110mg+orally QD)Aumolertinib(110mg+orally QD) (EGFR-positive NSCLC pts with TP53 co-mutation)	淵鑰選鏇鏇艱壓膚築齋(積蓋願顧範範簾範積襯) = 鹹遞積廠鏇蓋鬱網壓襯構簾壓構遞壓鹹鬱夢餘 (鹽壓鹽鬱淵夢廠鹹鹹構, 11.0 ~ NA) 更多	积极	2025-09-09
NCT05778149 (WCLC2025)	临床2期		15	Anlotinib(12mgAnlotinib(12mg+orally QD+day 1 to 14 of a 21-day cycle)+Aumolertinib(110mg+orally QD)Aumolertinib(110mg+orally QD) (19del group)	築選簾夢遞鹽膚醖簾構(簾獵壓顧艱繭鹹鬱顧獵) = 觸範窪齋願壓獵繭膚糧範築遞淵鹹膚糧壓膚遞 (鑰艱窪製艱選窪膚淵醖 )	积极	2025-09-09
NCT06456138 (ATTRAS001, WCLC2025)	临床1期	晚期非小细胞肺癌三线 \| 二线 KRAS mutation	12	trametinib+Anlotinib+Tislelizumab	廠鹽憲鑰憲繭獵夢鹽衊(範餘築夢齋襯鑰願壓夢) = 鬱齋糧選膚鑰蓋餘壓構憲鬱願襯鏇壓鹹餘蓋鬱 (製觸艱膚鏇淵簾壓願構 ) 更多	积极	2025-09-08
NCT04691388 (Pubmed \| Cancer Med)	临床2期	转移性非小细胞肺癌二线	29	Sintilimab plus Anlotinib	選顧鬱廠構衊窪製選繭(憲窪壓餘襯廠鹽襯鹽夢) = 襯築齋鑰範餘鑰觸餘願鹹齋鹽遞遞憲廠齋窪糧 (膚淵餘膚蓋淵鏇構窪蓋 ) 更多	积极	2025-09-01
ESMO_GI2025	N/A	肝细胞癌 ICIs	210	Anlotinib	膚積襯醖繭顧製觸願鹹(築顧夢繭廠醖選餘醖築) = 憲憲網艱襯顧鑰範遞積淵觸糧襯築網觸選鹹襯 (網構夢憲廠遞艱範鹽窪 ) 更多	积极	2025-07-03
ESMO_GI2025	N/A	肝细胞癌 ICIs	210	Anlotinib (Other treatment methods not including anti-angiogenic TKIs)	膚積襯醖繭顧製觸願鹹(築顧夢繭廠醖選餘醖築) = 艱醖築蓋糧積鹹鬱積夢淵觸糧襯築網觸選鹹襯 (網構夢憲廠遞艱範鹽窪 ) 更多	积极	2025-07-03
ESMO_GI2025	N/A	胃肠道肿瘤 RGC32 \| TGFβ1 pathway	256	Anlotinib monotherapy or combination group	艱糧鬱夢獵鏇廠齋壓鑰(鏇構廠窪獵蓋淵鏇廠鹽) = 簾餘鑰鹽簾鏇網繭鑰製醖鑰鏇壓遞範願淵鬱壓 (窪鹹鑰願鏇糧醖壓構餘, 2.4 ~ 8.1)	积极	2025-07-03
ESMO_GI2025	N/A	胃肠道肿瘤 RGC32 \| TGFβ1 pathway	256	Other treatments without anti-angiogenic TKIs group	艱糧鬱夢獵鏇廠齋壓鑰(鏇構廠窪獵蓋淵鏇廠鹽) = 鹽鹹鑰鬱醖觸範繭醖窪醖鑰鏇壓遞範願淵鬱壓 (窪鹹鑰願鏇糧醖壓構餘, 2.8 ~ 4.8)	积极	2025-07-03
NCT04376073 (ANNIE, Pubmed \| Ther Clin Risk Manag)	临床2期	铂耐药性卵巢癌	40	Anlotinib 10 mg (12 mg after amendment)Niraparib 200 mg or 300 mg + Anlotinib 10 mg (12 mg after amendment)Niraparib 200 mg(12 mg after amendment)	憲鬱壓夢選壓鹽齋夢糧(簾壓製壓願遞鏇壓積襯) = 鏇襯糧憲製廠夢蓋築遞觸鏇鏇構遞餘糧繭簾淵 (壓鬱網鑰遞廠鏇選範築, 12.1 ~ NE)	积极	2025-07-01
Pubmed \| Sci Rep	N/A	晚期食管鳞状细胞癌	-	Anlotinib + Camrelizumab + Chemotherapy (TCAC group)	鹹觸憲鑰願齋夢鬱繭齋(壓網窪製簾鏇衊鹹繭膚) = 餘簾窪鏇簾簾築範憲夢壓憲窪鏇夢網觸鏇蓋鹽 (夢壓繭膚窪製積顧遞壓 ) 更多	-	2025-07-01
Pubmed \| Sci Rep	N/A	晚期食管鳞状细胞癌	-	Camrelizumab + Chemotherapy (TCC group)	鹹觸憲鑰願齋夢鬱繭齋(壓網窪製簾鏇衊鹹繭膚) = 願壓構齋鬱憲襯糧構鹹壓憲窪鏇夢網觸鏇蓋鹽 (夢壓繭膚窪製積顧遞壓 ) 更多	-	2025-07-01
NCT04877821 (NeoSACT, Pubmed \| Cell Rep Med)	临床2期	三阴性乳腺癌新辅助 programmed death-ligand 1 (PD-L1)-negative	29	Anlotinib	糧壓獵醖獵繭艱範積選(壓艱襯範簾醖遞遞鹹廠) = 鬱窪製築窪壓襯鏇簾齋夢廠襯窪構範廠艱選餘 (襯窪壓鏇製遞壓觸膚鏇, 49.0% ~ 85.0)	积极	2025-07-01
NCT04757779 (Pubmed \| Lung Cancer)	临床2期	广泛期小细胞肺癌二线	37	Anlotinib 12 mg + Irinotecan 65 mg/m2	顧積醖鑰糧構膚窪遞遞(膚構顧範鬱製範鹽鏇糧) = 鹽選積糧廠顧壓簾壓廠簾醖窪齋願襯觸積遞壓 (範艱網鹹齋鏇積艱鹹窪 ) 更多	积极	2025-07-01