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更新于：2025-05-28
Anlotinib Dihydrochloride
盐酸安罗替尼
更新于：2025-05-28
概要
基本信息
非在研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2018-05-08), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国)、附条件批准 (中国)、特殊审批 (中国) |
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结构/序列
分子式C23H23ClFN3O3 |
InChIKeyGTAUHBAHFJIAQT-UHFFFAOYSA-N |
CAS号1360460-82-7 |
关联
662
项与 盐酸安罗替尼 相关的临床试验NCT06848439
A Phase II Study of Benmelstobart Combined With Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients With Locally Advanced Oral Cancer
Exploring the Safety and Efficacy of Benmelstobart Combined with Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients with Locally Advanced Oral Cancer
This is a single-center, Phase II study targeting patients with stage III-IVb locally advanced oral squamous cell carcinoma who meet the inclusion and exclusion criteria. The neoadjuvant therapy consists of Benmelstobart combined with Anlotinib and chemotherapy for 3 cycles (21 days per cycle). Surgery is performed within 2 weeks after completing neoadjuvant therapy. Postoperative adjuvant treatment is selected based on pathological grading:
Group A (Pathological Complete Response, pCR): Postoperative radiotherapy (RT) alone: 40Gy/5 weeks.
Group B (Major Pathological Response, MPR): Postoperative radiotherapy (RT) alone: 50Gy/5 weeks.
Group C (Partial Pathological Response/No Pathological Response):
Low-to-intermediate risk patients (no extracapsular nodal extension and negative margins): RT: 60Gy/6 weeks.
High-risk patients (extracapsular nodal extension and/or positive margins): Concurrent chemoradiotherapy (CCRT): 60-66Gy/6-6.6 weeks + Cisplatin: 60mg/m² every 3 weeks, 2-3 cycles.
Additionally, all patients will receive adjuvant Benmelstobart 3-4 weeks after surgery, followed by Benmelstobart maintenance therapy (total treatment duration of 1 year).
This is a single-center, Phase II study targeting patients with stage III-IVb locally advanced oral squamous cell carcinoma who meet the inclusion and exclusion criteria. The neoadjuvant therapy consists of Benmelstobart combined with Anlotinib and chemotherapy for 3 cycles (21 days per cycle). Surgery is performed within 2 weeks after completing neoadjuvant therapy. Postoperative adjuvant treatment is selected based on pathological grading:
Group A (Pathological Complete Response, pCR): Postoperative radiotherapy (RT) alone: 40Gy/5 weeks.
Group B (Major Pathological Response, MPR): Postoperative radiotherapy (RT) alone: 50Gy/5 weeks.
Group C (Partial Pathological Response/No Pathological Response):
Low-to-intermediate risk patients (no extracapsular nodal extension and negative margins): RT: 60Gy/6 weeks.
High-risk patients (extracapsular nodal extension and/or positive margins): Concurrent chemoradiotherapy (CCRT): 60-66Gy/6-6.6 weeks + Cisplatin: 60mg/m² every 3 weeks, 2-3 cycles.
Additionally, all patients will receive adjuvant Benmelstobart 3-4 weeks after surgery, followed by Benmelstobart maintenance therapy (total treatment duration of 1 year).
开始日期2025-06-15 |
申办/合作机构 |
ChiCTR2500102140
A single-arm, multicenter, exploratory clinical study of anlotinib hydrochloride combined with TQB2450 (PD-L1 inhibitor) in the treatment of advanced esophageal squamous cell carcinoma
开始日期2025-05-28 |
申办/合作机构- |
NCT06978153
Perioperative Treatment With Benmelstobart Combined With Chemotherapy With or Without Anlotinib in Resectable Limited-Stage Small Cell Lung Cancer: A Randomized, Two-Cohort, Multicenter, Phase II Clinical Study
A total of 66 patients were enrolled in this exploratory study and randomly assigned to cohort 1 and cohort 2, with 33 patients in each group. Cohort 1: Neoadjuvant therapy (benmelstobart combined with chemotherapy and anlotinib, 3 cycles, every 21 days is a cycle). Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart combined with anlotinib, 12 cycles, every 21 days is a cycle). Cohort 2: Neoadjuvant therapy (benmelstobart combined with chemotherapy, 3 cycles, every 21 days is a cycle). Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart, every 21 days is a cycle) .
开始日期2025-05-20 |
申办/合作机构 |
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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1,287
项与 盐酸安罗替尼 相关的文献（医药）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 ; Zhu, Xueru ; Li, Zhigang ; Fu, Xiaolong ; Zhao, Lei ; Cheng, Yan ; 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.
2025-08-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Development and validation of a UPLC-MS/MS method for almonertinib with its active metabolite HAS-719 and anlotinib in human plasma
Article
作者: Huang, Chenrong ; Qin, Yi ; Miao, Liyan ; Guan, Xiaojun ; Zhang, Zijie ; Zhang, Shichao
Almonertinib and anlotinib are tyrosine kinase inhibitors used to treat malignant tumors, with their combination currently applied to non-small cell lung cancer (NSCLC) patients. This study aimed to develop a simple and rapid UPLC-MS/MS method for simultaneously detecting almonertinib, its active metabolite HAS-719, and anlotinib in human plasma. The analytes were separated on a Waters HSST3-C18 column following protein precipitation with acetonitrile. Mass detection was performed on a Waters TQS triple quadrupole mass spectrometer under positive electrospray ionization mode. The MRM ions were m/z 526.5→71.96 for almonertinib, m/z 512.4 → 455.41 for HAS-719, m/z 408.16→ 339.03 for anlotinib and m/z 518.5→372.26 for d6-HAS-000719 (internal standard). Method validation followed FDA guidelines and Chinese Pharmacopoeia regulations, demonstrating acceptable accuracy, precision, matrix effects, recovery, and stability. The method showed excellent linearity over 0.5-500 ng/mL for all three analytes, with correlation coefficients (r²)≥ 0.99. The validated UPLC-MS/MS method successfully monitored almonertinib and anlotinib concentrations in clinical, particularly for NSCLC patients.
2025-07-01·Anti-Cancer Agents in Medicinal Chemistry
Safety and Efficacy of Anlotinib-based Regimen in Patients with Unresectable or Metastatic Bone and Soft-tissue Sarcomas: A Retrospective Institutional Study
Article
作者: He, Wei ; Gong, Shuai ; Zhang, Shengli ; Wang, Liye ; Pang, Lina
Background::
Anlotinib has demonstrated durable clinical benefits in patients with unresectable or
metastatic bone and soft-tissue sarcomas.
Methods::
92 patients treated with chemotherapy combined with or without anlotinib were collected and analyzed.
The objective response rate (ORR) and disease control rate (DCR) were analyzed. Long-term survival was assessed
using the Kaplan-Meier method, including median progression-free survival (mPFS) and overall survival
(mOS).
Results::
Liposarcoma, synovial sarcoma, and rhabdomyosarcoma were the primary pathological subtypes of the
92 patients. The median age was 46 (range, 11-75) years. The ORR and DCR of the anlotinib-chemotherapy
combination used as first-line therapy were 31.9% and 85.1%, respectively. However, the ORR and DCR were
only 6.7% and 57.8% in the chemotherapy alone, respectively. Compared with the chemotherapy group, improvements
were observed in the mPFS and mOS with anlotinib-based regimen (mPFS, 8.3 vs. 3.0 months; mOS,
59.0 vs. 22.0 months). Anlotinib-associated adverse events were well tolerated and mainly occurred in grades I
and II. New anlotinib-related adverse reactions were not noted.
Conclusion::
Anlotinib-based regimen as a first-line therapy showed a positive effect on the treatment of unresectable
or metastatic BSTSs. The anlotinib-associated adverse events were minor and well tolerated.
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项与 盐酸安罗替尼 相关的新闻（医药）2025-05-28
·肿瘤界
点击蓝字 关注我们前言作为肿瘤学领域的国际盛会，ASCO年会每年都吸引着来自世界各地的顶尖学者、临床专家与科研团队，共同分享最新研究成果、探讨创新疗法、展望未来趋势。随着2025年ASCO年会完整日程的正式公布，全球肿瘤学界的目光再次聚焦于此。在此，本文特整理了本届ASCO大会中肺癌领域入选的Oral Abstract Session（口头报告专场）、Rapid Oral Abstract Session（快速口头报告专场）以及Clinical Science Symposium（临床科学研讨会）的研究，让我们先一睹为快！Oral Abstract Session口头报告专场摘要号：2004研究英文名称：A phase II study of asandeutertinib (TY-9591) in advanced NSCLC patients with EGFR-positive mutations and brain metastases.研究中文名称：asandeutertinib（TY-9591）在EGFR阳性突变和脑转移的晚期NSCLC患者中的II期研究讲者：邢力刚 | 中国医学科学院肿瘤医院摘要号：3001研究英文名称：Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with driver genomic alterations (GA) outside of classic EGFR mutations.研究中文名称：BL-B01D1（iza-bren）治疗携带经典EGFR突变以外驱动基因改变的局部晚期或转移性NSCLC的I期临床研究：一种靶向EGFR×HER3的双特异特异性抗体驱动药物偶联物（ADC）的评估讲者：杨云鹏 | 中山大学肿瘤防治中心摘要号：3002研究英文名称：Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic small cell lung cancer (SCLC).研究中文名称：iza-bren（BL-B01D1），一种EGFR x HER3双特异性ADC，在局部晚期或转移性小细胞肺癌（SCLC）患者中的I期研究讲者：黄岩 | 中山大学肿瘤防治中心摘要号：LBA8000研究英文名称：Overall survival with neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) in patients with resectable NSCLC in CheckMate 816.研究中文名称：CheckMate 816研究中可切除NSCLC患者新辅助纳武利尤单抗联合化疗的总生存期分析讲者：Patrick M. Forde | Trinity St. James's Cancer Institute, Trinity College Dublin摘要号：8001研究英文名称：Neoadjuvant (neoadj) osimertinib (osi) ± chemotherapy (CT) vs CT alone in resectable (R) epidermal growth factor receptor-mutated (EGFRm) NSCLC: NeoADAURA.研究中文名称：NeoADAURA研究：可切除EGFR突变NSCLC术前新辅助奥希替尼±化疗对比单纯化疗讲者：Jamie E. Chaft | Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY; Department of Medicine, Weill Cornell Medical College摘要号：8002研究英文名称：Lung cancer diagnosis rates (LCDR) in lung cancer screening (LCS) and incidental pulmonary nodule (IPN) cohorts in the Mississippi Delta.研究中文名称：密西西比三角洲地区肺癌筛查与偶然发现肺结节队列中的肺癌诊断率研究讲者：Raymond U. Osarogiagbon | Baptist Cancer Center, Multidisciplinary Thoracic Oncology Program摘要号：8003研究英文名称：SWOG/NRG S1914: Randomized phase III trial of induction/consolidation atezolizumab + SBRT versus SBRT alone in high risk, early-stage NSCLC.研究中文名称：SWOG/NRG S1914研究：高危早期NSCLC诱导/巩固期阿替利珠单抗联合SBRT对比单纯SBRT的随机III期试验讲者：Megan Eileen Daly | Department of Radiation Oncology, University of California Davis Comprehensive Cancer Center摘要号：LBA8004研究英文名称：R-ALPS: A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of TQB2450 with or without anlotinib as maintenance treatment in patients with locally advanced and unresectable (stage III) NSCLC without progression following concurrent or sequential chemoradiotherapy.研究中文名称：R-ALPS研究：贝莫苏拜单抗（TQB2450）联合或不联合安罗替尼维持治疗经同步或序贯放化疗后无进展的局部晚期不可切除（III期）NSCLC患者的随机、双盲、安慰剂对照、多中心III期临床试验讲者：陈明 | 中山大学肿瘤防治中心摘要号：LBA8005研究英文名称：Randomized phase II trial investigating whether atezolizumab after chemoradiotherapy (CRT) prolongs survival in limited stage (LS) small cell lung cancer (SCLC).研究中文名称：局限期小细胞肺癌（LS-SCLC）化放疗后使用阿替利珠单抗是否延长生存的随机II期试验讲者：Bjorn Henning Gronberg | Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology and Department of Oncology, St. Olavs Hospital摘要号：8006研究英文名称：Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): Primary results of the phase 3 IMforte trial.研究中文名称：III期IMforte研究：芦比替定联合阿替利珠单抗作为广泛期小细胞肺癌（ES‑SCLC）患者一线维持治疗的主要结果讲者：Luis G. Paz-Ares | Hospital Universitario 12 de Octubre, H12O-CNIO Lung Cancer Unit, Universidad Complutense and Ciberonc摘要号：8007研究英文名称：A phase 2 dose expansion study of ZG006, a trispecific T cell engager targeting CD3/DLL3/DLL3, as monotherapy in patients with advanced small cell lung cancer.研究中文名称：ZG006（一种靶向CD3/DLL3/DLL3的三特异性T细胞接合器）单药治疗晚期SCLC的II期剂量扩展研究讲者：艾星浩 | 上海交通大学医学院附属胸科医院摘要号：LBA8008研究英文名称：Tarlatamab versus chemotherapy (CTx) as second-line (2L) treatment for small cell lung cancer (SCLC): Primary analysis of Ph3 DeLLphi-304.研究中文名称：Tarlatamab对比化疗（CTx）二线（2L）治疗SCLC：III期DeLLphi-304研究的主要分析讲者：Charles M Rudin | Fiona and Stanley Druckenmiller Center for Lung Cancer Research, Memorial Sloan Kettering Cancer Center摘要号：8500研究英文名称：First-line adagrasib (ADA) with pembrolizumab (PEMBRO) in patients (pts) with advanced/metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC) from the phase 2 portion of the KRYSTAL-7 study.研究中文名称：II期KRYSTAL‑7研究：adagrasib联合帕博利珠单抗一线治疗晚期/转移性KRASG12C突变NSCLC患者讲者：Pasi A. Jänne | Department of Medical Oncology, Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute摘要号：8501研究英文名称：TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC).研究中文名称：TROPION‑Lung02研究：Dato-DXd联合帕博利珠单抗±铂类化疗一线治疗晚期NSCLC讲者：Benjamin Philip Levy | Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine摘要号：LBA8502研究英文名称：CAMPASS: Benmelstobart in combination with anlotinib vs pembrolizumab in the first-line treatment of advanced non-small cell lung cancer (aNSCLC): A randomized, single-blind, multicenter phase 3 study.研究中文名称：CAMPASS研究：贝莫苏拜单抗联合安罗替尼对比帕博利珠单抗一线治疗晚期NSCLC：一项随机、单盲、多中心III期研究讲者：韩宝惠 | 上海交通大学医学院附属胸科医院摘要号：8503研究英文名称：Efficacy of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy with or without amivantamab.研究中文名称：zipalertinib对既往接受过含或不含埃万妥单抗铂类化疗的EGFR外显子20插入突变NSCLC患者的疗效评估讲者：Helena Alexandra Yu | Memorial Sloan Kettering Cancer Center摘要号：8504研究英文名称：SOHO-01: Safety and efficacy of BAY 2927088 in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC) who were pretreated but naïve to HER2-targeted therapy or had not received any treatment for advanced disease.研究中文名称：SOHO-01研究：BAY 2927088治疗既往接受过治疗但未接受HER2靶向治疗或未接受过任何治疗的晚期HER2突变NSCLC患者的疗效和安全性研究讲者：Herbert H. Loong | 香港中文大学摘要号：LBA8505研究英文名称：Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET-amplification (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study.研究中文名称：赛沃替尼联合奥希替尼对比化疗治疗EGFR-TKI治疗进展后EGFR突变伴MET扩增的晚期NSCLC：来自III期随机SACHI研究结果讲者：陆舜 | 上海市胸科医院摘要号：8506研究英文名称：Patritumab deruxtecan (HER3-DXd) in resistant EGFR-mutated (EGFRm) advanced non-small cell lung cancer (NSCLC) after a third-generation EGFR TKI: The phase 3 HERTHENA-Lung02 study.研究中文名称：Patritumab-deruxtecan（HER3-DXd）治疗第三代EGFR-TKI治疗后耐药的EGFR突变晚期NSCLC：III期HERTHENA-Lung02研究讲者：莫树锦 | 香港中文大学摘要号：8507研究英文名称：Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study.研究中文名称：芦康沙妥珠单抗（sac-TMT）治疗既往接受过治疗的晚期EGFR突变NSCLC：来自OptiTROP-Lung03随机研究的结果讲者：张力 | 中山大学肿瘤防治中心Rapid Oral Abstract Session快速口头报告专场摘要号：8009研究英文名称：Association of post-surgical MRD status with neoadjuvant ctDNA dynamics, genomic mutations, and clinical outcomes in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial.研究中文名称：III期AEGEAN研究：术后MRD状态与新辅助ctDNA动态、基因突变特征及可切除NSCLC患者预后的相关性分析讲者：Martin Reck | Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research摘要号：LBA8010研究英文名称：Perioperative nivolumab (NIVO) vs placebo (PBO) in patients (pts) with resectable NSCLC: Updated survival and biomarker analyses from CheckMate 77T.研究中文名称：CheckMate 77T研究：可切除NSCLC患者围手术期纳武利尤单抗对比安慰剂治疗的生存及生物标志物更新分析讲者：Mariano Provencio | Hospital Universitario Puerta de Hierro摘要号：8011研究英文名称：ctDNA-based MRD detection in unresectable NSCLC undergoing curatively intended chemoradiotherapy and durvalumab.研究中文名称：在接受根治性放化疗及度伐利尤单抗治疗的不可切除NSCLC患者中基于ctDNA的MRD检测讲者：Aslaug Helland | University of Oslo, Clinical Medicine摘要号：8012研究英文名称：The preliminary results of a randomized phase II trial evaluating induction toripalimab plus chemotherapy followed by concurrent chemoradiotherapy and consolidation toripalimab in bulky unresectable stage III non-small-cell lung cancer (InTRist).研究中文名称：InTRist研究：评估特瑞普利单抗联合诱导化疗，随后同步放化疗及特瑞普利单抗巩固治疗用于巨大不可切除的III期NSCLC的随机II期试验的初步结果讲者：Yu Wang | 中国医学科学院肿瘤医院摘要号：8013研究英文名称：Safety and efficacy of lurbinectedin plus atezolizumab as second-line treatment for advanced small-cell lung cancer: Results of the 2SMALL phase 1/2 study (NCT04253145).研究中文名称：I/II期2SMALL研究：芦比替定联合阿替利珠单抗作为晚期NSCLC二线治疗的疗效和安全性讲者：Santiago Ponce Aix | Hospital Universitario 12 de Octubre and Oncosur Foundation摘要号：8014研究英文名称：Clinical and molecular characteristics of early progressors (EPs) and long-term progression-free survivors (LTPs) from the phase 3 ADRIATIC trial of consolidation durvalumab (D) vs placebo (P) after concurrent chemoradiotherapy (cCRT) in limited-stage small-cell lung cancer (LS-SCLC).研究中文名称：III期ADRIATIC研究：同步放化疗后巩固度伐利尤单抗对比安慰剂治疗用于LS-SCLC患者中早期进展者与长期无进展生存者的临床与分子特征讲者：David Allen Barbie | Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute摘要号：8015研究英文名称：Alectinib as neoadjuvant treatment in potentially resectable stage III ALK-positive NSCLC: Final analysis of ALNEO phase II trial (GOIRC-01-2020-ML42316).研究中文名称：阿来替尼作为新辅助治疗用于潜在可切除III期ALK阳性NSCLC的ALNEO II期研究最终分析（GOIRC-01-2020-ML42316）讲者：Marcello Tiseo | Department of Medicine and Surgery, University of Parma; Medical Oncology Unit, University Hospital of Parma; Gruppo Oncologico Italiano di Ricerca Clinica, GOIRC摘要号：8016研究英文名称：Efficacy and safety of nivolumab plus ipilimumab for patients with pre-treated type B3 thymoma and thymic carcinoma: Results from the EORTC-ETOP NIVOTHYM phase II trial.研究中文名称：纳武利尤单抗联合伊匹木单抗治疗经治的B3型胸腺瘤和胸腺癌患者的疗效与安全性：EORTC-ETOP NIVOTHYM II期研究结果讲者：Nicolas Girard, MD | Institut du Thorax Curie Montsouris, Institut Curie, Paris, and UVSQ, Paris Saclay University摘要号：8017研究英文名称：Integrin αVβ3-targeted imaging for identification of lung cancer and mapping of lymph-node metastases: A prospective, multicenter, self-controlled phase 3 trial (TRIIL study).研究中文名称：靶向整合素αVβ3的成像用于肺癌的识别和淋巴结转移的定位：一项前瞻性、多中心、自身对照的III期试验（TRIIL研究）讲者：Rongxi Wang | 北京协和医院摘要号：8512研究英文名称：Telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met protein–targeting antibody-drug conjugate (ADC), in patients (pts) with advanced EGFR-mutated (MT) non-squamous (NSQ) non-small cell lung cancer (NSCLC): Results from a phase 1 study.研究中文名称：靶向c-Met的抗体偶联药物（ADC）Telisotuzumab adizutecan（ABBV-400；Temab-A）治疗晚期EGFR突变非鳞NSCLC的I期研究结果讲者：David Ross Camidge | University of Colorado Cancer Center摘要号：8513研究英文名称：Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO).研究中文名称：II期SAVANNAH研究随机亚组结果：赛沃替尼联合奥希替尼对比赛沃替尼联合安慰剂的疗效及中枢神经系统结果分析讲者：Benjamin Philip Levy | Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine摘要号：8514研究英文名称：Phase 3 study of benmelstobart in combination with chemotherapy followed by sequential combination with anlotinib for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC).研究中文名称：贝莫苏拜单抗联合化疗，随后序贯联合安罗替尼一线治疗局部晚期或转移性鳞状NSCLC的III期研究讲者：石远凯 | 中国医学科学院肿瘤医院摘要号：8515研究英文名称：Plasma-guided adaptive first-line chemoimmunotherapy for non-small cell lung cancer (NSCLC).研究中文名称：血浆引导的NSCLC一线个体化化免治疗探索讲者：Julia K. Rotow | Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute摘要号：8516研究英文名称：Randomized trial of relevance of time-of-day of immunochemotherapy for progression-free and overall survival in patients with non-small cell lung cancer.研究中文名称：NSCLC患者免疫化疗时间与无进展生存期及总生存期相关性的随机试验讲者：张永昌 | 湖南省肿瘤医院摘要号：8517研究英文名称：Hypoxia-responsive CEA CAR-T cells therapy for relapsed or refractory non-small cell lung cancer: A single-arm, open-label, phase I trial.研究中文名称：缺氧反应型CEA CAR-T细胞疗法治疗复发或难治性NSCLC：一项单臂、开放标签、I期试验讲者：魏双 | 华中科技大学同济医学院附属同济医院摘要号：8518研究英文名称：S1900E: A phase II study examining impact of co-mutations on sotorasib for previously treated stage IV/recurrent KRAS G12C mutated (MUT) non-squamous (Non-sq) non-small cell lung cancer (NSCLC) (ECOG-ACRIN led Lung-MAP Sub-study).研究中文名称：S1900E研究：评估合并突变对sotorasib治疗经治的KRAS G12C突变IV期/复发性非鳞NSCLC疗效影响的II期研究（ECOG-ACRIN主导Lung-MAP子研究）讲者：Sukhmani Kaur Padda | Fox Chase Cancer Center/Temple Health摘要号：8519研究英文名称：Safety and efficacy of olomorasib + immunotherapy in first-line treatment of patients with KRAS G12C-mutant advanced NSCLC: Update from the LOXO-RAS-20001 trial.研究中文名称：Olomorasib联合免疫治疗用于KRAS G12C突变晚期NSCLC一线治疗的疗效和安全性：LOXO-RAS-20001研究更新讲者：Konstantin H. Dragnev | Dartmouth Cancer Center摘要号：8520研究英文名称：Sosimerasib monotherapy in patients with previously treated KRAS G12C–mutated non-small cell lung cancer: Primary results of a phase 2 study.研究中文名称：Sosimerasib单药治疗KRAS G12C突变NSCLC：II期研究的主要结果讲者：王洁 | 中国医学科学院肿瘤医院摘要号：LBA8671研究英文名称：PRAGMATICA-LUNG (SWOG S2302): A prospective, randomized study of ramucirumab plus pembrolizumab versus standard of care for participants previously treated with immunotherapy for stage IV or recurrent non-small cell lung cancer.研究中文名称：Practicala-LUNG研究（SWOG S2302）：雷莫芦单抗联合帕博利珠单抗对比标准治疗用于既往接受过免疫治疗的IV期或复发性NSCLC患者的前瞻性随机研究讲者：Konstantin H. Dragnev | Dartmouth Cancer CenterClinical Science Symposium临床科学研讨会摘要号：8509研究英文名称：First-in-class PD-1/IL-2 bispecific antibody IBI363 in patients (Pts) with advanced immunotherapy-treated non-small cell lung cancer (NSCLC).研究中文名称：首创新药PD-1/IL-2双特异性抗体IBI363治疗经免疫治疗的晚期NSCLC患者讲者：周建娅 | 浙江大学医学院附属第一医院摘要号：8510研究英文名称：Efficacy and safety of MHB088C, a novel B7-H3-targeted ADC, in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC): Subgroup analysis from a phase 1/2 multicenter study.研究中文名称：一项评估新型靶向B7-H3的ADCMHB088C治疗复发ES-SCLC的疗效与安全性的I/II期多中心研究的亚组分析讲者：周彩存 | 同济大学附属东方医院摘要号：8511研究英文名称：First report of efficacy and safety results from a phase 2 trial evaluating BNT327/PM8002 plus chemotherapy (chemo) as first-line treatment (1L) in unresectable malignant mesothelioma.研究中文名称：首个评估BNT327/PM8002联合化疗作为不可切除恶性胸膜间皮瘤一线治疗的II期试验的疗效及安全性结果报告讲者：程颖 | 吉林省肿瘤医院备注：如有遗漏或任何问题，请给我们留言~声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。来源：医脉通胸部肿瘤编辑：lagertha审核：南星
抗体药物偶联物临床结果ASCO会议临床1期
2025-05-28
·米内网
精彩内容近段时间，创新药领域风起云涌：1类新药密集获批，国产新药出海再现“天价”交易等。据不完全统计，2018年至今（截至5月27日，下同），国内有超150款国产1类新药获批上市，以抗肿瘤和免疫调节剂为主，恒瑞医药强势领跑。从销售额看，53款国产1类新药2024年在中国三大终端六大市场销售过亿，16个超10亿大爆品亮眼。随着创新药的逐步放量，以及BD项目不断刷新交易额记录，创新药企有望迎来扭亏为盈的密集期。超150款国产1类新药获批！恒瑞强势领跑近年来，随着药品审评审批制度改革、全链条支持创新药等系列政策出台，我国创新药进入全面爆发阶段。米内网数据显示，2018年至今，国内有超150款国产1类新药（按新版注册管理办法，不含中成药、原料药、疫苗等）获批上市，其中化学药占比超过65%，治疗用生物制品占比超过34%。从时间段看，2020年新版药品注册管理办法实施后，国产1类新药获批数量大幅提升，由2018及2019年的个位数，增长至2020年的13个，2021年突破20个，2022年有所回落，2023及2024年均达30个及以上，预计2025年有望再创新高。2018年至今获批上市的国产1类新药（不含中成药）注：以最早获批年份计从治疗领域看，超150款国产1类新药分布在11个治疗大类，集中在抗肿瘤和免疫调节剂，共计78个，占比超过49%；此外，全身用抗感染药物、消化系统及代谢药分别有29个、18个品种在列，占比分别超过18%、11%。虽然我国创新药仍有扎堆肿瘤领域的现象，但在代谢、麻醉、自免、心血管、抗病毒、皮肤等领域亦有涉及，逐渐呈现“全面开花”之势。超150款国产1类新药治疗大类分布情况米内网数据显示，近年来中国三大终端六大市场抗肿瘤和免疫调节剂（不含中成药，下同）、消化系统及代谢药销售额均超过2000亿元，全身用抗感染药物销售额均超过1600亿元。从企业看，20余家药企（按集团计）均有2个及以上的新药获批，其中恒瑞医药以16个品种强势领跑，正大制药、浙江我武生物以6个品种并列第二，豪森药业以5个品种排位第四，海思科、康方生物以4个品种并列第五。此外，百济神州、贝达药业、东阳光药、和黄医药、石药集团、再鼎医药、四环医药、君实生物、信达生物等均有3个品种在列。获批品种数TOP5集团注：以上市许可持有人计16个超10亿大爆品亮眼！这些品种上市即起飞从商业化后的销售额看，2018至2023年获批的国产1类新药中，有53款2024年在中国三大终端六大市场的销售额超过1亿元，合计销售额超过500亿元。16个超10亿大品种亮眼，百济神州的替雷利珠单抗注射液、信达生物的信迪利单抗注射液、豪森药业的甲磺酸阿美替尼片依次位列前三，销售额均超40亿元；正大天晴药业的盐酸安罗替尼胶囊以超38亿元紧接在后，恒瑞医药的注射用卡瑞利珠单抗、百济神州的泽布替尼胶囊、先声药业的依达拉奉右莰醇注射用浓溶液均超20亿元。从增长情况看，恒瑞医药的瑞维鲁胺片及脯氨酸恒格列净片、山东罗欣药业的替戈拉生片、华领医药的多格列艾汀片、成都微芯药业的西格列他钠片、荣昌生物的注射用泰它西普等涨幅均超过100%（2023年获批的品种不计在内）。2018至2023年获批且销售额超过1亿元的国产1类新药注：标红为增速超10%，2023年获批的品种不计在内来源：米内网综合数据库恒瑞医药以9个品种领跑。注射用卡瑞利珠单抗（PD-1单抗）、马来酸吡咯替尼片（多靶点激酶抑制剂）、海曲泊帕乙醇胺片（TPO受体激动剂）、瑞维鲁胺片（AR受体拮抗剂）、羟乙磺酸达尔西利片（CDK4/6抑制剂）、阿得贝利单抗注射液（PD-L1单抗）在上市首年或次年销售额即超过1亿元，其中2018年获批的马来酸吡咯替尼片，2019年销售额接近8亿元，2021年超过19亿元，之后有所波动，2025年超过16亿元；2021年获批的海曲泊帕乙醇胺片，2022年销售额接近6亿元，2023年突破12亿元，2024年突破15亿元；此外，脯氨酸恒格列净片（SGLT2抑制剂）最早于2021年获批，2024年销售额增速约达475%。近年来中国三大终端六大市场恒瑞医药部分1类新药销售情况（单位：万元）来源：米内网格局数据库豪森药业有4个品种在列。甲磺酸阿美替尼片（三代EGFR抑制剂）、甲磺酸氟马替尼片（BCR-ABL抑制剂）、艾米替诺福韦片（核苷酸类逆转录酶抑制剂）在上市首年或次年销售额即超过1亿元，其中2020年获批的甲磺酸阿美替尼片，当年销售额即接近5亿元，2021年超过16亿元，2024年突破40亿元；2021年获批的艾米替诺福韦片，2022年销售额接近3亿元，2024年突破8亿元，作为一款非肿瘤药，该新药上市后的市场表现让人眼前一亮。近年来中国三大终端六大市场豪森药业部分1类新药销售情况（单位：万元）来源：米内网格局数据库作为国内首款获批的国产双抗，以及全球首款获批的PD-1/CTLA-4双抗，康方生物的卡度尼利单抗注射液不负众望，上市后市场表现亮眼。该药最早于2022年获批上市，当年销售额即超过3亿元，2023年突破12亿元，2024年突破15亿元。目前卡度尼利单抗注射液已有宫颈癌（二线）、胃癌（一线）等适应症获批，非小细胞肺癌、肝细胞癌等适应症处于III期临床。近年来中国三大终端六大市场卡度尼利单抗注射液销售情况（单位：万元）来源：米内网格局数据库激励政策频出，创新药企将迎业绩拐点近几年来，国家层面频频出台利好政策，创新药的研发、审评、生产和支付等环节的政策环境显著优化。2024年以来，创新药产业支持政策持续加码，从支付渠道拓展、目录动态调整到临床应用保障等方面构建了全链条支持体系，旨在缩短创新药上市周期并优化市场环境。在利好政策支撑下，越来越多的创新药在进入医保后实现快速放量，国产创新药在与MNC（跨国药企）合作中不断刷新交易额记录，并在海外市场陆续兑现商业化预期，这些都标志着我国医药产业的高质量创新已逐步迈入兑现期。据2024年业绩报告显示，以百济神州为代表的众多创新药企业绩相比往年显著好转，预示着整个创新药板块有望迎来盈利拐点。A股“研发投入一哥”百济神州表现亮眼，2024年营业收入272.14亿元（+56.2%），其中产品收入269.94亿元（+74.1%），亏损进一步收窄约26.9%。业绩增长的关键因素是其核心产品的出色表现，2024年泽布替尼销售额高达188.59亿元，在公司总营收中占比超六成；替雷利珠单抗销售额44.67亿元，同比增长17.4%。依靠产品收入增长和授权费收入增加，以及持续改善运营效率，信达生物2024年业绩大涨，其营业收入94.22亿元（+51.8%），其中产品收入82.28亿元（+43.6%），授权费收入则由4.47亿元翻倍增加至11亿元；年内亏损降至9463.1万元，同比缩窄90.8%，年内Non-IFRS（非国际财务报告准则）利润、Non-IFRS EBITDA（税息折旧及摊销前利润）双双首次转正。得益于卡度尼利单抗销售持续增长和依沃西单抗在2024年5月获批上市后带来的积极销售贡献，康方生物2024年扣除分销成本后的商业销售收入达20.02亿元，同比增长24.88%。康方生物董事会主席夏瑜表示：“2025年是公司产品进入医保的元年。到目前为止，还在非常快速放量起量的过程之中。”BD项目收入成为康宁杰瑞业绩扭亏为盈的关键，2024年公司实现总收入6.4亿元，同比增长192.58%，年内溢利约为1.66亿元，上年同期则为亏损2.11亿元。这一年，康宁杰瑞分别与ArriVent、Glenmark以及石药集团达成三笔合作，交易总金额超125亿元。资料来源：米内网数据库、公司公告注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：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5月27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
免疫疗法上市批准疫苗
2025-05-28
2025年美国临床肿瘤学会（ASCO）大会上，正大天晴正式披露1类创新药——TQB2868（PD-1/TGF-β双功能融合蛋白）联合方案一线治疗mPDAC的Ⅱ期临床研究（TQB2868-ALTN-Ⅱ-01）初步数据。“免疫+靶向+化疗”三重机制的联合疗法在胰腺癌领域取得了令人振奋的临床疗效，并为其他“免疫冷肿瘤”的治疗提供了可借鉴的创新范式。五年生存率不足10%，标准化疗方案陷瓶颈在全球肿瘤治疗领域，胰腺癌是公认恶性程度最高的肿瘤之一，因极低的五年生存率（不足10%）和迅猛的疾病进展被称为“癌中之王”。对于占确诊患者80%以上的转移性胰腺癌（mPDAC）而言，吉西他滨+白蛋白结合型紫杉醇（AG）的系统性化疗仍是当前一线标准治疗方案，但其中位总生存期（mOS）始终难以突破1年[1-3]，临床亟需新的治疗方案。近年来，免疫治疗在非小细胞肺癌、黑色素瘤等多个癌种中展现出革命性突破，但单一的免疫检查点抑制剂（ICI）对胰腺癌并没有起到良好的抗肿瘤作用，这可能与胰腺癌独特的肿瘤微环境（TME）有关[4]。研究显示，胰腺癌微环境中存在致密的基质成分，并有广泛的免疫抑制细胞浸润，会抑制肿瘤细胞的免疫应答，造成免疫逃逸，从而影响免疫治疗效果[5-7]。胰腺癌因此被认为是一种免疫学上的“冷肿瘤”。免疫+靶向+化疗，三重机制破冰“冷肿瘤”TQB2868为正大天晴自主研发的PD-1/TGF-β双功能融合蛋白，联合盐酸安罗替尼与AG化疗，形成独特的“免疫-靶向-化疗”三重协同机制，直击胰腺癌“冷肿瘤”特性，为破解免疫逃逸提供了全新路径：●TQB2868通过阻断PD-1与其配体PD-L1之间的结合，解除肿瘤细胞对T细胞的抑制作用，从而激活T细胞对肿瘤的攻击；●TGF-β可抑制机体的免疫功能, 帮助肿瘤细胞免疫逃逸，TQB2868通过中和TGF-β信号可逆转肿瘤细胞免疫逃逸；●联合方案中，安罗替尼具有抑制肿瘤血管新生、抑制肿瘤生长、调控免疫微环境的作用；●AG化疗直接杀伤肿瘤细胞并释放抗原，增强免疫应答。6个月PFS率86%，中位OS或将突破一年TQB2868-ALTN-Ⅱ-01研究是一项评估TQB2868注射液联合安罗替尼与化疗（AG方案）一线治疗mPDAC的有效性和安全性的Ⅱ期临床研究。截至2025年1月，该研究已入组40例，均为IV期转移性胰腺癌患者，其中36例可评估，初步数据[8]显示：●客观缓解率（ORR）达63.9%，为AG化疗方案历史数据（23%-36%）[1-3]的2-3倍；●疾病控制率（DCR）达100%，是AG化疗方案（62.3%）的1.6倍；●中位无进展生存期（mPFS）尚未达到，6个月PFS率达86%，是AG化疗方案（43.2%）的2倍；●中位生存期（mOS）尚未达到，预期有望超过1年；●安全耐受性良好，3级及以上不良反应发生率为52.5%（AG化疗方案为68.1%-77%）。基于Ⅱ期临床优异的探索数据，公司正与监管部门沟通关键注册Ⅲ期研究。该疗法有望成为免疫检查点抑制剂在胰腺癌的首个一线治疗方案，为胰腺癌患者的总生存期、生活质量带来根本性改善。我们非常欣喜地看到，这一创新疗法在转移性胰腺癌领域取得了令人振奋的临床表现。TQB2868通过特异性阻断TGF-β信号通路，首次在临床研究中证实可有效逆转胰腺癌的免疫荒漠状态，为破解“冷肿瘤”免疫抵抗提供了直接证据；TQB2868 联合方案开启“免疫 + 靶向 + 化疗”三重机制新时代，通过三重作用模式，实现了免疫激活、血管重塑与肿瘤杀伤的多靶点协同，有望建立胰腺癌一线治疗中首个免疫联合治疗标准方案。期待TQB2868联合方案有机会启动全球多中心注册Ⅲ期临床研究，以“中国原创方案”重塑全球胰腺癌治疗格局。此外，该研究为前列腺癌等其他“冷肿瘤”的免疫治疗开发提供了可借鉴的创新范式，展现了联合机制探索在攻克难治性肿瘤中的关键价值。这项研究不仅是为“癌中之王”摘帽的重要探索，而且将为更多免疫“冷肿瘤”的治疗提供借鉴。参考文献：[1] D, El-Maraghi RH, Hammel P, et al. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial. J Natl Cancer Inst.2015;107(2): dju413.[2] Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364(19):1817-25.[3] Wainberg ZA, Melisi D, Macarulla T, et al. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023 Oct 7;402(10409):1272-81.[4] Balachandran VP, Luksza M, Zhao JN, et al. Identification of unique neoantigen qualities in long-term survivors of pancreatic cancer[J].Nature, 2017, 551(7681): 512-516.[5] Skelton RA, Javed A, Zheng L, et al. Overcoming the resistance of pancreatic cancer to immune checkpoint inhibitors [J]. J Surg Oncol, 2017, 116(1): 55-62. [6] Amedei A, Niccolai E, Prisco D. Pancreatic cancer: role of the immune system in cancer progression and vaccine-based immunotherapy [J]. Hum Vaccin Immunother, 2014, 10(11): 3354-3368. [7] Steele CW, Karim SA, Leach JDG, et al. CXCR2 Inhibition Profoundly Suppresses Metastases and Augments immunotherapy in Pancreatic Ductal Adenocarcinoma [J]. Cancer Cell, 2016, 29(6): 832-845.[8] Si Shi, Xianjun Yu,Xiaobing Chen, et al. TQB2868 combined with anlotinib and nab-paclitaxel plus gemcitabine as first-line treatment for metastatic pancreatic cancer: A prospective, multicenter, single-arm, phase 2 study.2025 ASCO(#4159).▲ 上下滑动查看更多声明：1.新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。2.本公司不对任何药品和/或适应症作推荐。3.本新闻稿中涉及的信息仅供参考，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。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。
ASCO会议免疫疗法临床2期临床结果临床1期
100 项与 盐酸安罗替尼 相关的药物交易
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 转移性肾细胞癌 | 中国 | 2025-05-13 | |
| 不可切除的肾细胞癌 | 中国 | 2025-05-13 | |
| 子宫内膜癌 | 中国 | 2024-11-22 | |
| 广泛期小细胞肺癌 | 中国 | 2024-05-08 | |
| 分化型甲状腺癌 | 中国 | 2022-04-08 | |
| 甲状腺髓样癌 | 中国 | 2021-01-30 | |
| 小细胞肺癌 | 中国 | 2019-09-01 | |
| 软组织肉瘤 | 中国 | 2019-07-01 | |
| 非小细胞肺癌 | 中国 | 2018-05-14 | |
| 局部晚期非小细胞肺癌 | 中国 | 2018-05-08 | |
| 转移性非小细胞肺癌 | 中国 | 2018-05-08 |
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 |
|---|---|---|---|---|
| 晚期鳞状非小细胞肺癌 | 申请上市 | 中国 | 2025-04-23 | |
| 非小细胞肺癌 III期 | 申请上市 | 中国 | 2025-04-23 | |
| 肝细胞癌 | 申请上市 | 中国 | 2024-11-21 | |
| 原发性腹膜癌 | 临床3期 | 美国 | 2022-04-06 | |
| 原发性腹膜癌 | 临床3期 | 美国 | 2022-04-06 | |
| 原发性腹膜癌 | 临床3期 | 中国 | 2022-04-06 | |
| 原发性腹膜癌 | 临床3期 | 中国 | 2022-04-06 | |
| 原发性腹膜癌 | 临床3期 | 意大利 | 2022-04-06 | |
| 原发性腹膜癌 | 临床3期 | 意大利 | 2022-04-06 | |
| 原发性腹膜癌 | 临床3期 | 西班牙 | 2022-04-06 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床3期 | 649 | 餘鬱獵淵襯鬱網選憲鬱(網窪繭範鬱壓範鑰願網) = 鏇範餘遞遞繭鹹襯夢積 願壓選窪鬱構艱遞鹹餘 (範淵簾襯艱網鹹鹹選蓋, 5.8 ~ 8.0) 更多 | 积极 | 2025-05-14 | |||
餘鬱獵淵襯鬱網選憲鬱(網窪繭範鬱壓範鑰願網) = 顧遞憲積壓構選鬱膚醖 願壓選窪鬱構艱遞鹹餘 (範淵簾襯艱網鹹鹹選蓋, 2.7 ~ 4.1) 更多 | |||||||
N/A | 实体瘤 TNM staging | 911 | 蓋鑰憲壓鬱淵廠鑰築艱(網簾餘襯繭願簾壓鏇範) = 9.7% 餘鹹齋鑰願齋鬱醖範蓋 (襯醖夢艱壓淵醖窪憲獵 ) 更多 | 积极 | 2025-04-29 | ||
Anlotinib combination therapy | |||||||
临床3期 | 鳞状非小细胞肺癌 一线 | - | 網糧鹽餘獵淵遞觸獵壓(觸獵艱衊製鑰膚蓋選膚) = 显著延长 膚餘蓋襯網壓鹹觸糧築 (窪艱選構鏇觸餘餘膚鏇 ) 达到 | 优效 | 2025-04-24 | ||
替雷利珠单抗 + 化疗 | |||||||
临床2期 | 头颈部鳞状细胞癌 新辅助 | 22 | 安罗替尼+顺铂+白蛋白紫杉醇 | 製醖蓋夢願窪鹽鑰鑰積(鹹醖蓋獵夢醖築衊積積) = 網餘網鹹夢選蓋鑰鹽鑰 獵構壓糧顧膚觸憲簾顧 (鑰衊膚餘獵膚鑰築獵鹹 ) 更多 | 积极 | 2025-04-14 | |
N/A | 746 | 廠鏇範艱選夢遞網築襯(願鬱膚衊願膚簾積醖衊) = 夢製艱願淵鏇蓋繭糧製 糧遞糧遞繭襯襯範餘艱 (遞遞艱顧夢範壓廠遞鹽 ) | 积极 | 2025-03-26 | |||
廠鏇範艱選夢遞網築襯(願鬱膚衊願膚簾積醖衊) = 鹹選鏇繭遞鏇襯夢鏇顧 糧遞糧遞繭襯襯範餘艱 (遞遞艱顧夢範壓廠遞鹽 ) | |||||||
N/A | 539 | 鹽顧膚窪齋蓋遞廠醖構(襯範壓製襯襯醖膚淵構) = 10.2% 糧鏇艱築鏇憲艱鹽網繭 (鏇願鏇遞觸製壓淵製憲 ) 更多 | 积极 | 2025-03-26 | |||
Combined therapy | |||||||
N/A | 295 | 憲簾製願範積製壓鏇壓(遞壓選網窪鹹顧選糧廠) = 範顧範鏇廠構蓋顧憲齋 繭積選鬱遞遞遞簾鹹憲 (襯顧艱夢糧鏇醖廠衊鏇, 3.70 ~ 4.47) 更多 | 积极 | 2025-03-20 | |||
Anlotinib plus chemotherapy | 憲簾製願範積製壓鏇壓(遞壓選網窪鹹顧選糧廠) = 獵積獵糧齋遞醖窪構夢 繭積選鬱遞遞遞簾鹹憲 (襯顧艱夢糧鏇醖廠衊鏇, 4.10 ~ 5.53) | ||||||
临床3期 | 结直肠癌 末线 | 73 | 醖選鏇構鑰蓋積鬱鹹鏇(簾廠鏇糧製鑰壓積艱繭) = 窪壓構蓋築廠繭衊鹹艱 廠獵製願淵網鬱構窪憲 (淵選糧選壓積壓醖觸顧, 3.4 ~ 4.6) 更多 | 积极 | 2025-01-23 | ||
临床2期 | 食管鳞状细胞癌 辅助 | 30 | 積齋齋衊構鹽構觸簾壓(顧壓積鑰糧餘齋鹽遞觸) = not reached 選獵鹹夢醖醖壓膚壓蓋 (鏇窪餘簾鑰遞鏇鏇鑰淵 ) 更多 | 积极 | 2025-01-23 | ||
临床2期 | 30 | Anlotinib + Penpulimab + Nab-paclitaxel | 範醖襯窪鏇廠衊積製糧(積顧憲製積獵艱鏇鏇製) = 夢構窪糧遞構願壓廠齋 艱蓋顧淵餘觸壓鹽遞艱 (製鑰觸襯鹽繭糧憲築製, 7.57 ~ 14.11) 更多 | 积极 | 2025-01-23 |
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