预约演示

更新于：2025-05-07

Gastroesophageal junction adenocarcinoma

胃食管交界处腺癌

更新于：2025-05-07

基本信息

别名

Adenocarcinoma of Cardioesophageal Junction、Adenocarcinoma of Cardioesophageal junction、Adenocarcinoma of Gastroesophageal Junction

+ [15]

简介

An adenocarcinoma that arises from and straddles the junction of the stomach and esophagus. The category of adenocarcinomas of the gastroesophageal junction also includes the majority of adenocarcinomas previously called gastric cardia adenocarcinomas. Squamous cell carcinomas that affect or cross the junction of the stomach and esophagus are classified as carcinomas of the distal esophagus. Adenocarcinoma of the gastroesophageal junction occurs more often in Caucasian middle aged and elderly males. Clinical signs and symptoms include dysphagia, abdominal pain, and weight loss. The prognosis depends on the completeness of the surgical resection, the number of lymph nodes involved by cancer, and the presence or absence of postoperative complications. The presence of TP53 mutations indicates worse prognosis.

关联

271

项与胃食管交界处腺癌相关的药物

Sacituzumab tirumotecan

芦康沙妥珠单抗

靶点

Top I x Trop-2

作用机制

TOP1抑制剂 [+1]

在研机构

Merck Sharp & Dohme LLC [+5]

原研机构

四川科伦药业股份有限公司

在研适应症

EGFR阳性非鳞状非小细胞肺癌 [+51]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2024-11-22

Zanidatamab

泽尼达妥单抗

靶点

HER2

作用机制

HER2拮抗剂 [+1]

在研机构

Jazz Pharmaceuticals Plc [+6]

原研机构

Zymeworks BC, Inc.

在研适应症

HER2阳性胆道肿瘤 [+23]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2024-11-20

Trastuzumab Biosimilar (Prestige BioPharma)

曲妥珠单抗生物类似药（Prestige BioPharma）

靶点

HER2

作用机制

HER2拮抗剂 [+1]

在研机构

Prestige BioPharma Ltd.

原研机构

Prestige BioPharma Ltd.

在研适应症

HER2阳性乳腺癌 [+3]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

欧盟 [+3]

首次获批日期2024-09-19

987

项与胃食管交界处腺癌相关的临床试验

NCT06846346

/ Not yet recruiting临床2期IIT

Phase II Study Evaluating Ivonescimab in Combination With Chemotherapy for First- and Second-line Treatment of Advanced or Metastatic Gastric and Gastroesophageal Adenocarcinoma Patients

The goal of this clinical trial is to evaluate the addition of ivonescimab to standard chemotherapy in patients with advanced or metastatic gastric and gastroesophageal adenocarcinoma. The main question it aims to answer is : Does the addition of ivonescimab increase the response to treatment ? Participants will visit the clinic every 2 weeks for checkups, treatment administration and tests for collection of adverse events.

开始日期2025-09-01

申办/合作机构

UNICANCER

[+1]

NCT06702384

/ WithdrawnN/AIIT

A Prospective Translational Tissue Collection Study in Early and Advanced Gastric and Oesophageal Cancers to Enable Further Disease Characterisation and the Development of Potential Predictive and Prognostic Biomarkers

A prospective translational tissue collection study to identify biomarkers predictive of treatment response/resistance and biomarkers of prognostic value from a series of patients who are investigated for and diagnosed with early or advanced gastric/junctional or oesophageal cancer (oesophagogastric cancer) at The Royal Marsden Hospital.

开始日期2025-08-01

申办/合作机构

Royal Marsden NHS Foundation Trust

NCT06748872

/ Not yet recruiting临床1期

EPITOME-1015-I: a Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of a Third Generation TCR-T Therapy, MDG1015, in Epithelial Ovarian Carcinoma, Gastroesophageal (Junction) Adenocarcinoma, Myxoid (Round Cell) Liposarcoma And/or Synovial Sarcoma Subjects with Advanced Disease Expressing NY-ESO-1 And/or LAGE-1a

MDG1015 is a third generation TCR-T therapy product targeting NY-ESO-1/LAGE-1a armored and enhanced by the PD1-41BB costimulatory switch protein (CSP). The study purpose is to establish the safety, tolerability and preliminary efficacy of MDG1015 in patients with epithelial ovarian cancer, gastroesophageal adenocarcinoma, round cell liposarcoma and/or synovial sarcoma that expresses NY-ESO-1 and/or LAGE-1a.
The main questions this clinical trial aims to answer are:
Can this TCR-T therapy MDG1015 be given to patients safely? What is the optimal dose of the TCR-T therapy MDG1015? If and what side effects do participants experience after receiving the TCR-T therapy MDG1015? Do participants experience a potential disease response after receiving the TCR-T therapy MDG1015?
Participants will:
Receive (in most cases) 1 single infusion of MDG1015 at a pre-defined dose level and will be followed up regularly up to 1 year. After one year, participants will enter the long term follow-up part up to 15 years after being treated. Any side effects and/or potential disease response will be documented during this period.

开始日期2025-07-01

申办/合作机构

MediGene AG

100 项与胃食管交界处腺癌相关的临床结果

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100 项与胃食管交界处腺癌相关的转化医学

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0 项与胃食管交界处腺癌相关的专利（医药）

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2,733

项与胃食管交界处腺癌相关的文献（医药）

2025-07-01·Cancer Letters

Efficacy of the first-line immune checkpoint inhibitor plus chemotherapy for gastroesophageal cancer: A meta-analysis of phase III trials including unreported PD-L1 subgroups

Article

作者: Lee, Choong-Kun ; Yun, Choa ; Chung, Hyun Cheol ; Lee, Yaeji ; Hong, Moonki ; Rha, Sun Young ; Nam, Chung Mo ; Park, Sejung

The treatment paradigm for gastroesophageal cancers is evolving with immune checkpoint inhibitors (ICIs) as first-line therapy, making it crucial to understand their efficacy across patient subgroups, especially concerning PD-L1 expression. We performed a meta-analysis of Phase III randomized controlled trials targeting the effectiveness of ICIs with or without chemotherapy for advanced/metastatic HER2-negative gastroesophageal adenocarcinoma (GEA) or esophageal squamous cell carcinoma (ESCC). Kaplan-Meier (KM) curves of all-comer populations and subgroups according to reported PD-L1 cut-offs were extracted from published reports. Using KMSubtraction algorithm, unreported PD-L1 subgroup survival data were reconstructed by utilizing published KM survival curves. Thirteen first-line phase III RCTs involving 11,795 patients with GEA or ESCC were included. For GEA, ICI with or without chemotherapy showed longer OS in patients with PD-L1 combined positive score ≥1 (HR 0.77, 95 % confidence intervals [CI] 0.71-0.83 for ICI plus chemotherapy; HR 0.86, 95 %CI 0.75-1.01 for ICI alone) compared to chemotherapy alone, showing less benefits in low PD-L1 subgroups. ICI, with or without chemotherapy displayed survival benefits among PD-L1 tumor proportion score ≥1 % for ESCC (HR 0.62, 95 %CI 0.52-0.74 for ICI plus chemotherapy; HR 0.67, 95 %CI 0.54-0.84 for ICI alone) compared to chemotherapy alone. ICI combinations were similarly beneficial for Asian and global patients with GEA or ESCC. In conclusion, this meta-analysis, which includes unreported PD-L1 subgroups show benefit of ICIs with or without chemotherapy as a first-line treatment for advanced gastroesophageal cancers, particularly among patients with high PD-L1 expression.

2025-05-01·Gastric Cancer

Multi-omics sequencing of gastroesophageal junction adenocarcinoma reveals prognosis-relevant key factors and a novel immunogenomic classification

Article

作者: Shang, Xiaobin ; Li, Mengting ; Luo, Huijuan ; Yue, Jie ; Yu, Zhentao ; Wu, Kui ; Sui, Zhilin ; Ma, Zhao ; Chen, Chuangui ; Li, Fuqiang ; Wu, Xianxian ; Xu, Bo ; Gao, Na ; Jiang, Hongjing ; Duan, Xiaofeng ; Meng, Fianbiao ; Luo, Tian

BACKGROUNDGastroesophageal junction adenocarcinoma (GEJAC) exhibits distinct molecular characteristics due to its unique anatomical location. We sought to investigate effective and reliable molecular classification of GEJAC to guide personalized treatment.METHODSWe analyzed the whole genomic, transcriptomic, T-cell receptor repertoires, and immunohistochemical data in 92 GEJAC patients and delineated the landscape of genetic and immune alterations. In addition to COSMIC nomenclature, the de novo nomenclature was also utilized to define signatures and investigate their correlation with survival. A novel molecular subtype was developed and validated in other cohorts.RESULTSWe found 30 mutated driver genes, 7 novel genomic signatures, 3 copy-number variations, and 2 V-J gene usages related to prognosis that were not identified in previous study. A high frequency of COSMIC-SBS-384-1 and De novo-SV-32-A was associated with more neoantigen generation and a better survival. Using 19 molecular features, we identified three immune-related subtypes (immune inflamed, intermediate, and deserted) with discrete profiles of genomic signatures, immune status, and clinical outcome. The immune deserted subtype (27.2%) was characterized by an earlier KRAS mutation, worse immune reaction, and prognosis than the other two subtypes. The immune inflamed subtypes exhibited the highest levels of neoantigens, TCR/pMHC-binding strength, CD8 + T-cell infiltration, IFN-α/γ response pathways, and survival rate.CONCLUSIONSThese results emphasize the immune reaction and prognostic value of novel molecular classifications based on multi-omics data and provide a solid basis for better management of GEJAC.

2025-05-01·ESMO Open

Claudin 18.2: a promising actionable target in biliary tract cancers

Article

作者: Bergamo, F ; Luchini, C ; Cillo, U ; Ceccon, C ; Sacchi, D ; Angerilli, V ; Rizzato, M ; Niero, M ; Gasparello, J ; Franzina, C ; Dei Tos, A P ; Lonardi, S ; Fassan, M ; Sabbadin, M

BACKGROUND AND PURPOSEAnti-claudin 18.2 (anti-CLDN18.2) therapy has been approved for patients with CLDN18-positive gastric and gastroesophageal junction adenocarcinomas. The current study aims at evaluating the expression of CLDN18 in a large cohort of pathologically characterized biliary tract cancers (BTCs).MATERIALS AND METHODSA series of 237 BTCs were collected and reviewed under the BITCOIN protocol. All samples were assessed for CLDN18 status using immunohistochemistry (clone 43-14A). Tumor positivity for CLDN18 was determined if ≥75% of tumor cells exhibited moderate-to-strong membranous staining.RESULTSCLDN18 expression was found in 29.5% of BTCs (70/237), with the highest rates in gallbladder carcinoma (GBC; 62.5%; 20/32) and extrahepatic cholangiocarcinoma (eCCA; 53.4%; 31/58), compared with intrahepatic cholangiocarcinoma (iCCA; 12.9%; 19/147) (P < 0.0001). CLDN18 positivity was detected in 5.5% of cases (13/237), most common in GBC (15.6%; 5/32), followed by eCCAs (8.6%; 5/58) and iCCAs (2.0%; 3/147) (P = 0.0045). Most CLDN18-positive samples (10/13) exhibited a heterogenous staining pattern. In iCCAs, large duct subtypes had higher CLDN18 expression [33.3% (10/30) versus 7.7% (9/117), P = 0.0002] and positivity [6.7% (2/30) versus 0.9% (1/117), P = 0.106] than small duct iCCAs. No significant differences were observed across GBC and eCCA histotypes, and CLDN18 was not associated with IDH1 or FGFR2 status in iCCAs.CONCLUSIONSThis study demonstrates that CLDN18 expression is present in a subset of BTCs, with significantly higher positivity rates in GBCs and eCCAs compared with iCCAs. In iCCAs, CLDN18 expression was more frequent in the large duct subtype but was not associated with IDH1 or FGFR2 status. These findings suggest that CLDN18 could be a potential therapeutic target in BTCs, warranting further prospective studies to evaluate its clinical significance and impact on patient outcomes.

1,565

项与胃食管交界处腺癌相关的新闻（医药）

2025-05-05

·ioncology

IGCC前瞻丨中国专家20项口头报告摘要闪耀国际舞台

IGCC 2025微专辑扫描二维码可查看更多内容编者按由国际胃癌学会（IGCA）主办的第16届国际胃癌大会（IGCC 2025）将于2025年5月7~10日在荷兰阿姆斯特丹隆重召开。作为全球胃癌研究领域具影响力的学术盛会，本届大会将汇聚来自世界各地的顶尖专家学者，聚焦胃癌诊疗前沿进展。值得关注的是，中国专家将在多个专题会场发表重要研究成果，展现我国在该领域的学术影响力。经《肿瘤瞭望消化时讯》系统梳理会议日程，现共整理出20项中国专家入选的口头报告摘要标题（中英文对照）供读者预览。若有遗漏或表述偏差，诚挚欢迎学界同仁批评指正。一、5月8日专题报告Session 1a：分期专场时间：11:45中文标题：多参数MRI与双能CT在胃癌局部区域分期中的对比研究英文标题：Multiparametric MRI versus Dual-Energy CT in Gastric Cancer Locoregional Staging专家：Qiong Li，南京医科大学第一附属医院时间：12:05中文标题：基于优化淋巴结分期的胃癌新辅助治疗后ypTNM分期细化英文标题：Refined ypTNM Staging for Gastric Cancer After Neoadjuvant Therapy Based on Optimal Lymph Node Staging专家：Baolong Li，福建医科大学附属协和医院Session 1b：肿瘤内科-免疫治疗专场时间：11:45中文标题：术前免疫治疗与dMMR/MSI-H胃癌病理反应改善相关英文标题：Preoperative immunotherapy is associated with better pathological response in dMMR/MSI-H gastric cancer专家：Hong Zeng，复旦大学附属中山医院时间：12:05中文标题：蛋白质组学分析预测胃癌新辅助放化疗免疫疗效英文标题：Proteomic Analysis Predicts Therapeutic Outcomes of Neoadjuvant Chemo-immunotherapy in Gastric Cancer Patients专家：崔昊，中国人民解放军总医院第一医学中心Session 1c：胃肠病学/内镜/早期胃癌专场时间：11:55中文标题：全腹腔镜与腹腔镜辅助远端胃癌根治术对早期胃癌患者生活质量的影响分析英文标题：Morbidity and quality of totally laparoscopic versus laparoscopy-assisted distal gastrectomy for early gastric cancer’s life专家：黄华，复旦大学附属肿瘤医院Session 2a：肿瘤内科-靶向治疗专场时间：16:40中文标题：T细胞激活增强抗HER2介导的胃癌抗体依赖性细胞毒性英文标题：T-cell activation enhances anti-HER2-mediated antibody-dependent cellular cytotoxicity in gastric cancer专家：薛子睿，复旦大学附属中山医院Session 2b：放射肿瘤学专场时间：16:30中文标题：可切除食管胃结合部腺癌新辅助斯鲁利单抗联合放化疗的Ⅱ期更新结果英文标题：Neoadjuvant Serplulimab with Concurrent Chemoradiotherapy in Resectable Esophagogastric Junction Adenocarcinoma: Phase 2 Updated Results专家：赵林，北京协和医院时间：16:40中文标题：可切除食管胃腺癌放化疗价值的Meta分析英文标题：The value of chemoradiation therapy for resectable esopho-gastric adenocarcinomas: A meta-analysis of randomized clinical trials专家：Tao Fu，中日友好医院Session 2c：胃癌手术创新专场时间：16:40中文标题：D2+CME根治术对局部进展期胃癌的肿瘤学疗效：RCT三年随访结果英文标题：The oncological efficacy of D2+CME for locally advanced gastric cancer: 3-year outcomes of a RCT专家：龚建平，华中科技大学同济医学院附属同济医院二、5月9日专题报告3x接受口头摘要全体会议：HDGC/预康复专场时间：9:40中文标题：多学科预康复改善老年虚弱胃癌患者临床结局英文标题：Supervised multimodal prehabilitation to improve the clinical outcomes of frail elderly patients with gastric cancer专家：Yuqi Sun，青岛大学附属医院Session 3a：病理学/转化研究专场时间：11:55中文标题：FGFBP2+NK细胞作为胃癌免疫治疗预测性生物标志物的角色解析英文标题：Unraveling the Role of FGFBP2+NK Cells as Predictive Biomarkers in Gastric Adenocarcinoma Immunotherapy专家：潘宏达，复旦大学附属肿瘤医院Session 3b：人工智能与精准手术专场时间：11:45中文标题：机器学习模型预测胃癌患者术后并发症英文标题：Machine Learning Models for Predicting Postoperative Surgical Complications in Gastric Cancer Patients专家：Xiaohan Cui，山东大学齐鲁医院时间：12:05中文标题：基于多场景血管识别的AI驱动胃癌微创手术导航系统英文标题：AI-driven Surgical Navigation System based on Multi-scene Vessel Recognition for Minimally Invasive Gastric Cancer Surgery专家：Hao Chen，南方医科大学南方医院Session 3c：生活质量/支持治疗专场时间：11:55中文标题：中国胃癌手术质量与经济学评价：基于PACAGE研究分析英文标题：Surgical Quality and Economic Evaluation of Gastric Cancer Surgery in China: Analysis of PACAGE study专家：吴舟桥，北京大学肿瘤医院Session 4b：多模态治疗专场时间：16:30中文标题：AS与CAPOX在Ⅲ期胃腺癌术后化疗中的生存与安全性更新英文标题：AS versus CAPOX in postoperative chemotherapy for stage Ⅲ gastric adenocarcinoma patients: survival and safety update专家：俞鹏飞，浙江省肿瘤医院Session 4c：手术拓展-局限性Ⅳ期胃癌治疗专场时间：16:40中文标题：腹腔联合静脉化疗对比静脉紫杉醇+S-1治疗腹膜转移胃癌：DRAGON-01试验结果英文标题：Intraperitoneal+intravenous vs. intravenous paclitaxel+S-1 in gastric cancer with peritoneal metastasis: Results from DRAGON-01 trial专家：严超，上海交通大学医学院附属瑞金医院三、5月10日专题报告3x接受口头摘要全体会会议：手术专场时间：9:30中文标题：食管胃结合部腺癌纵隔淋巴结清扫的多中心队列研究中期分析英文标题：Lower mediastinal lymphadenectomy for adenocarcinoma of esophagogastric junction: interim analysis of a multicenter cohort study专家：李子禹，北京大学肿瘤医院时间：9:40中文标题：全腹腔镜与腹腔镜辅助全胃切除术疗效比较：CLASS08多中心RCT研究英文标题：The Efficacy of Totally Laparoscopic versus Laparoscopic-Assisted Total Gastrectomy: The CLASS08 Multicentre Randomized Controlled Trial专家：Qingya Li，南京医科大学第一附属医院Session 5a：肿瘤内科-新药与技术专场时间：11:55中文标题：替雷利珠单抗联合安罗替尼与XELOX一线治疗晚期胃/胃食管结合部腺癌（TALENT研究）英文标题：Tislelizumab Combined with Anlotinib and XELOX as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma (TALENT)专家：Ling Ma，南京医科大学第一附属医院Session 5c：视频专场：如何应对治疗失败时间：11:45中文标题：D2+CME手术技术演示英文标题：D2+CME surgery专家：龚建平，华中科技大学同济医学院附属同济医院综上，本届IGCC大会中，中国专家在胃癌的分期诊断、免疫治疗、微创手术、多学科预康复等领域贡献多项突破性研究成果，涵盖临床分期优化、新型靶向药物联合方案、AI手术辅助系统等技术进展。特别关注领域包括：免疫治疗标志物探索（如dMMR/MSI-H分型与FGFBP2+NK细胞）、手术技术创新（如D2+CME根治术、全腹腔镜操作安全性）、多学科综合治疗（新辅助放化疗、多学科预康复模式）等。这些研究不仅展现中国在胃癌诊疗领域的国际影响力，更为全球患者带来潜在诊疗方案优化契机。期待中国专家在阿姆斯特丹的学术舞台上发出更强音！（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。

临床2期免疫疗法

2025-05-01

·江苏康宁杰瑞生物制药有限公司

HER2双抗KN026关键性Ⅱ/Ⅲ期临床研究期中分析达到PFS主要终点

2025年5月1日，中国苏州，康宁杰瑞生物制药（股票代码：9966.HK）与石药集团（股票代码：1093.HK）共同宣布，HER2双特异性抗体KN026联合化疗二线及以上治疗HER2阳性胃癌（包括胃-食管结合部腺癌）的Ⅱ/Ⅲ期临床研究（研究编号：KN026-001）已完成首次期中分析，经独立数据监察委员会（IDMC）评估，达到预先设定的无进展生存期（PFS）的主要终点，具有统计学显著性和临床意义。KN026-001是一项随机、多中心、Ⅱ/Ⅲ期临床研究，旨在评估KN026联合化疗用于一线治疗失败的HER2阳性晚期、不可切除或转移性胃癌（包括胃-食管结合部腺癌）患者的疗效。该研究的第二阶段为随机、双盲、安慰剂对照的Ⅲ期研究，入组既往至少一线标准治疗失败的HER2阳性胃癌（包括胃-食管结合部腺癌）患者，按照1:1随机接受KN026联合化疗或安慰剂联合化疗治疗，主要终点为经独立评审委员会(IRC)评估的PFS和总生存期(OS)。期中分析结果显示，与现有标准治疗相比，KN026联合化疗显著改善了患者的PFS，降低了疾病进展/死亡的风险，并具有OS获益趋势。该研究的详细数据将在近期国际学术会议上公布。关于KN026 KN026是康宁杰瑞采用具有自主知识产权Fc异二聚体平台技术(CRIB)开发的HER2双特异性抗体，可同时结合HER2的两个非重叠表位，阻断HER2信号。相比于曲妥珠单抗和帕妥珠单抗联用，KN026针对HER2阳性肿瘤细胞有更强的抑制杀伤；另外KN026对于曲妥珠单抗抗性细胞株也有抑制作用。多项不同阶段临床研究表明，在经过包括抗HER2在内的多线治疗后进展的HER2阳性乳腺癌和胃癌患者中，KN026仍然表现出显著的抗肿瘤活性。目前针对二线及以上HER2阳性胃癌/胃食管结合部癌、一线HER2阳性乳腺癌、HER2阳性乳腺癌新辅助等适应症的多项注册临床研究正在进行中。KN026联合化疗用于一线标准治疗失败的HER2阳性胃癌（包括胃-食管结合部腺癌）获国家药品监督管理局（NMPA）药品审评中心（CDE）授予突破性疗法认定。2021年8月，康宁杰瑞与石药集团全资附属公司上海津曼特生物科技有限公司（以下简称“津曼特生物”）就KN026签订了在中国内地的开发及商业化授权协议。津曼特生物获得KN026在中国内地（不包括香港、澳门及台湾地区）在乳腺癌、胃癌适应症上的排他性开发与独占性商业化许可权。康宁杰瑞是一家以创新驱动、聚焦肿瘤治疗领域的生物制药公司，依托自主研发的单域抗体、双特异性抗体、糖基定点偶联、连接子载荷、双载荷抗体偶联及大分子药物高浓度皮下制剂等核心技术平台，构建具有差异化和国际竞争力的产品矩阵，覆盖抗体偶联药物（ADC）、双抗及单域抗体等前沿领域。公司已有1个产品获批上市（恩沃利单抗注射液KN035，商品名：恩维达®，全球首个皮下注射PD-(L)1抑制剂），在肿瘤治疗的便捷性和可及性上做出了重大突破。此外，公司有多个双抗和双抗ADC项目在临床研究阶段，并且快速推进以双抗ADC和双载荷ADC为主的临床前管线。公司已与石药集团、ArriVent、Glenmark等合作方达成多项针对产品或技术平台的战略合作。“康达病患，瑞济万家”。康宁杰瑞致力于解决未满足的临床需求，不断努力，开发高效、安全、具有全球竞争优势的抗肿瘤药物，惠及患者。欢迎访问公司网站：www.alphamabonc.com前瞻性陈述本新闻稿包含与我们未来业务、财务表现和涉及康宁杰瑞未来事件相关的声明，这些声明或构成前瞻性陈述。此类陈述包括预测和估计及关联的基本假设、有关潜在可能性的计划和期望的陈述，以及有关未来活动、运营及表现的陈述。这些陈述或可用诸如"预期"、"期待"、"预计"、"打算"、"计划"、"相信"、"寻求"、"估计"、"将"或类似含义的词语来标识。此类陈述基于康宁杰瑞管理和业务运营的当前某些假设，且受包括但不限于政治、经济、法律环境和商业环境等多种风险和不确定性的影响，康宁杰瑞的实际经营结果、表现或业绩可能较相关前瞻性陈述中明确或暗含的描述呈现（正面或负面）变化。除适用法律的要求外，无论出于新信息、未来事件还是其他原因，康宁杰瑞均无义务公开更新任何前瞻性陈述，且不为无法实现该等前瞻性陈述而承担责任。医药信息声明康宁杰瑞不推荐任何已获批或正在研发的药品/适应症临床使用，本文所包含的任何信息不应被看作是任何药物的申请、推广或广告。

临床2期突破性疗法临床3期申请上市

2025-05-01

·石药集团

KN026关键性II/III期临床研究的期中分析达到无进展生存期(PFS)主要终点

4月30日，石药集团（1093.HK）宣布，本公司附属公司上海津曼特生物科技有限公司与江苏康宁杰瑞生物制药有限公司合作开发的KN026（重组人源化抗HER2双特异性抗体注射液）用于至少接受过一种系统性治疗（必须包含曲妥珠单抗联合化疗）失败的HER2阳性局部晚期、复发或转移性的胃癌（包括胃-食管结合部腺癌）受试者的关键性II/III期临床研究(KC-WISE)，经独立数据监察委员会(IDMC)评估，达到预先设定的无进展生存期(PFS)的主要终点，具有统计学显著性和临床意义。KN026是一种HER2双特异性抗体，可以同时结合HER2的两个非重叠表位，导致HER2信号阻断，其治疗效果优于曲妥珠单抗和帕妥珠单抗联用的效果。多项不同阶段临床研究结果表明，KN026具有良好的疗效和安全性。目前针对乳腺癌、胃癌（包括胃-食管结合部腺癌）等适应症的多项注册临床研究正在进行中。KN026联合化疗用于一线标准治疗失败的HER2阳性胃癌（包括胃-食管结合部腺癌）已于2023年11月获中华人民共和国国家药品监督管理局(NMPA)药品审评中心(CDE)授予突破性疗法认定。KC-WISE(KN026-001)研究是一项随机、多中心、Ⅱ/Ⅲ期临床研究，旨在评估KN026联合化疗用于一线标准治疗失败的HER2阳性的局部晚期、复发或转移性胃癌（包括胃-食管结合部腺癌）受试者的疗效和安全性。该研究的Ⅲ期临床研究阶段，入组人群为既往至少接受过一线标准治疗失败的HER2阳性的胃癌（包括胃-食管结合部腺癌）受试者，按照1:1随机接受KN026联合化疗或安慰剂联合化疗治疗。该研究的主要终点为经独立评审委员会(IRC)评估的PFS和总生存期(OS)。本次计划的期中分析的主要目的是对经IRC评估的PFS进行有效性分析。期中分析结果显示，与现有标准治疗相比，KN026联合化疗显着改善了患者的PFS，降低了疾病进展/死亡的风险，并具有OS获益趋势。该研究的详细数据将在近期国际学术会议上公布。【声明】1、本新闻旨在分享公告信息，非广告用途；2、本资料仅供医药专业人士参考，非产品推荐依据，也不应被视为诊疗建议。

突破性疗法临床2期临床3期