An Exploratory Clinical Study of Adebrelimab Combined with Apatinib and Chemotherapy as Neoadjuvant Therapy for Initially Unresectable Stage III Non-Small Cell Lung Cancer

开始日期2025-12-01

申办/合作机构

哈尔滨医科大学

NCT07238569

/ Not yet recruiting临床3期IIT

Multicenter, Prospective Phase III Clinical Trial of EBV-DNA-Guided Adaptive Immunotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma

This trial evaluated the efficacy of two adjuvant regimens following identical induction and concurrent chemoradiotherapy (IC+CCRT) in locoregionally advanced nasopharyngeal carcinoma (LANPC) patients with persistent EBV DNA positivity or stable disease after three IC cycles. The control arm received adjuvant adebrelimab, while the experimental arm received adebrelimab plus capecitabine.

开始日期2025-12-01

申办/合作机构

中山大学

NCT07239596

/ Not yet recruiting临床1/2期

An Open, Multicenter Phase Ib/II Clinical Study of SHR-8068 in Combination With Adebrelimab and Other Anti-tumor Drugs for the Treatment of Advanced Renal Cell Carcinoma

This study evaluated the safety and efficacy of SHR-8068 in combination with Adebrelimab and other anti-tumor drugs in the treatment of advanced renal cell carcinoma

开始日期2025-12-01

申办/合作机构

苏州盛迪亚生物医药有限公司

100 项与阿得贝利单抗相关的临床结果

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100 项与阿得贝利单抗相关的转化医学

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100 项与阿得贝利单抗相关的专利（医药）

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项与阿得贝利单抗相关的文献（医药）

2025-11-01·International Journal of Surgery

Neoadjuvant immunochemotherapy with adebrelimab combined with the TP regimen for locally advanced OSCC: early results of a single-arm phase II clinical trial

Article

作者: Wang, Yan ; Li, Wenhao ; Wang, Yuepeng ; Cai, Yongkang ; Guo, Junhong ; Kang, Ziqin ; Fang, Songling ; Huang, Zhiquan ; Zhuang, Xiumei ; Wen, Zuozhen ; Huang, Zixian ; He, Yilin

Background::

This study aimed to investigate the efficacy of a PD-L1 inhibitor combined with chemotherapy in the treatment of locally advanced oral squamous cell carcinoma (OSCC).

Materials and Methods::

This study was designed as a single-arm phase II trial, and a total of 30 patients were enrolled. All patients were pathologically confirmed to have head and neck squamous cell carcinoma. Patients received paclitaxel, carboplatin, and adebrelimab every 3 weeks as a treatment cycle, followed by surgery after three cycles of treatment. The primary endpoint was the postoperative pathological complete response (PCR) rate. The secondary endpoints included the objective response rate (ORR), major pathological response (MPR) rate, 2-year disease-free survival rate, and 2-year and 5-year overall survival rates. This study was conducted without using artificial intelligence (AI) tools in accordance with the TITAN Guidelines 2025.

Results::

Among the 30 patients, 28 completed the full three cycles of immunochemotherapy, with an ORR of 60.7%. One patient dropped out, and one patient (3.3%) experienced grade 3–4 adverse reactions, leading to discontinuation after the first cycle. In the per-protocol population, 10 patients (35.7%) achieved a PCR in both the primary lesion and lymph nodes, whereas 18 patients (64.3%), including those with a PCR, achieved a MPR. Additionally, 20 patients (71.4%) achieved clinical to pathological downstaging. Common adverse reactions included alopecia (30; 100%), fatigue (7; 23.3%), anemia (24; 80%), hyperthyroidism (2; 6.7%), and pruritus (5; 16.7%).

Conclusions::

Preoperative neoadjuvant immunochemotherapy effectively improved the PCR rate in patients with locally advanced OSCC. PD-L1 inhibitors combined with chemotherapy have promising preliminary efficacy in patients with resectable locally advanced OSCC. However, additional follow-up is needed to obtain more comprehensive survival data and further validate these initial observations.

2025-07-01·BMJ Open Gastroenterology

Adebrelimab plus capecitabine versus capecitabine monotherapy for adjuvant treatment of high-risk resected cholangiocarcinoma (ACHIEVE): protocol for a phase II, multicentre, randomised controlled trial

Article

作者: Cheng, Yuan ; Li, Xiangcheng ; Li, Changxian ; Zhang, Yaodong

Introduction:

Cholangiocarcinoma (CCA) carries a high risk of recurrence even after curative resection. Capecitabine is standard adjuvant therapy, but recurrence rates remain significant, particularly in high-risk patients. Immunotherapy has shown promise in advanced CCA, prompting investigation into its role in earlier settings.

Methods and analysis:

This multicentre, randomised, open-label phase II trial will compare adjuvant adebrelimab plus capecitabine versus capecitabine alone in patients with high-risk resected CCA. The study is being conducted at four tertiary hospitals in Jiangsu Province, China. Eligible patients will be randomised 1:1. The primary endpoint is 1-year recurrence-free survival rate (1y-RFS rate). Secondary endpoints are overall survival, RFS and safety. Exploratory endpoints are circulating tumour DNA (ctDNA)-based MRD assessment.

Ethics and dissemination:

The study is approved by the Institutional Review Board of Jiangsu Provincial People’s Hospital (2024-SR571). Informed consent will be obtained from all participants. The findings will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number:

NCT06607276 .

2025-06-01·BMJ Open

Clinical study of adebrelimab in combination with apatinib and irinotecan for PD-1 inhibitor-ineffective advanced-stage gastric cancer: study protocol for a single-arm, single-centre, exploratory trial

Article

作者: Xia, Xiang ; Guan, Yujing ; Bai, Long ; Aimaiti, Muerzhate ; Zhang, Hao-yu ; Wang, Shuchang ; Ni, Bo ; Yue, Ben ; Gu, Jiayi ; Liu, Tao ; Zhang, Zizhen ; Zhang, Yeqian

Introduction:

Immunotherapy has revolutionised cancer treatment. Immune checkpoint inhibitors have demonstrated significant efficacy across multiple tumour types, including gastric cancer, where several approved programmed cell death 1/programmed cell death-ligand 1 (PD-1/PD-L1) inhibitors show promising antitumour activity. While PD-L1 expression serves as a predictive biomarker for PD-1 inhibitor response, and PD-L1-positive patients generally show better outcomes, therapeutic resistance remains a challenge. Many initial responders eventually develop resistance, and surprisingly, some PD-L1-positive patients fail to achieve expected response rates, indicating emerging resistance mechanisms in potentially responsive populations. Adebrelimab, a PD-L1 inhibitor, demonstrates mechanistic advantages over PD-1 inhibitors, with clinical studies suggesting promising therapeutic potential. When combined with irinotecan, apatinib has shown efficacy in second-line gastric cancer treatment. This study aims to evaluate the efficacy and safety of combining adebrelimab with apatinib and irinotecan for advanced gastric cancer refractory to PD-1 inhibitors.

Method and analysis:

This single-arm, single-centre exploratory trial will be conducted at Renji Hospital, enrolling 32 patients aged 18–75 years. Eligible patients must have initially achieved partial response, complete response or stable disease with progression-free survival (PFS)≥3 months during prior immunotherapy but subsequently progressive disease on imaging. Treatment will continue until meeting discontinuation criteria. The primary endpoint is objective response rate with Clopper-Pearson 95% CI. Secondary endpoints include disease control rate (95% CI), PFS and overall survival (estimated by Kaplan-Meier method), along with safety assessments.

Ethics and dissemination:

All participants will provide informed consent. The protocol has been approved by the Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee (LY2023-201-C). The results will be disseminated through peer-reviewed manuscripts, reports and presentations.

Trial registration number:

ChiCTR2300077329.

552

项与阿得贝利单抗相关的新闻（医药）

2025-12-02

·生物制品圈

2025 ESMO Asia前瞻 | 聚焦中国智慧，哪些研究值得关注？

2025年12月5-7日，2025 ESMO Asia年会将于新加坡召开。作为亚洲乃至全球肿瘤学领域的一项重要学术会议，本次大会将公布多项可能改变临床实践的研究，包括：本次大会将发布三份针对肝细胞癌、胰腺癌和非小细胞肺癌的《ESMO临床实践指南》泛亚洲指南改编版（PAGA）。这些指南将在考量西方国家与亚洲地区在遗传特征、生物学行为及临床实践方面差异的基础上，探讨患者的最佳管理策略（专题会议环节）。早发性癌症将成为新加坡国立癌症中心Eileen Y. Poon医生主题演讲的焦点。演讲将探讨该疾病的科学特异性，以及在治疗年轻成年患者时，超越现有标准方案和常规实践所需考虑的实际问题。多份研究将深入剖析乳腺癌治疗中的群体多样性，其中包括一项显示联合疗法能改善亚洲患者预后同时保持其生活质量的亚组分析研究（LBA1），以及一项大型基因组分析，该分析揭示了与血统相关的突变差异，有望指导更个性化的治疗并减少医疗差异（66MO）。同时，值得关注的是，本次大会将有近60项中国研究以口头报告形式发布。本文整理如下，以供参考。胸部恶性肿瘤 Proffered Paper session： LBA11 A Phase II Clinical Study of Dose Optimization for ZG006 (Alveltamig) in Patients with Advanced Small Cell Lung Cancer Who Have Received at Least Two Prior Lines of Therapy (ZG006-002) 中文标题：ZG006（Alveltamig）在既往至少接受过两线治疗的晚期小细胞肺癌患者中的剂量优化Ⅱ期临床研究（ZG006-002）讲者：李子明上海市胸科医院（上海交通大学医学院附属胸科医院） Mini Oral session 1： LBA14 First-in-Human Phase 1 Study of GTA182, a Novel MTA-Cooperative PRMT5 Inhibitor, in Patients with MTAP-Deleted Advanced Non-Small Cell Lung Cancer 中文标题：新型MTA协同PRMT5抑制剂GTA182在MTAP缺失晚期非小细胞肺癌患者中的首次人体Ⅰ期研究讲者：陆舜上海市胸科医院（上海交通大学医学院附属胸科医院） 928MO ARTEMIS-001: A Phase 1 Study of HS-20093 (GSK5764227) in Patients With Non-Small Cell Lung Cancer (NSCLC) 中文标题：ARTEMIS-001：HS-20093（GSK5764227）在非小细胞肺癌（NSCLC）患者中的Ⅰ期研究讲者：段建春中国医学科学院肿瘤医院 978MO Sintilimab Plus Platinum-Based Chemotherapy With vs Without Autologous CIK Cell Therapy in Metastatic NSCLC: A Multicenter Randomized Study 中文标题：信迪利单抗联合铂类化疗联合或不联合自体CIK细胞疗法治疗转移性非小细胞肺癌：一项多中心随机研究讲者：黄鼎智天津医科大学肿瘤医院 929MO Becotatug (JMT101, Beco) Combined with Docetaxel (Albumin-Bound, HB1801) for the Treatment of Patients (pts) with Locally Advanced Squamous Cell Non-Small Cell Lung Cancer (sqNSCLC) -A randomized control phase II study (BATTLE study) 中文标题：Becotatug（JMT101，Beco）联合多西他赛（白蛋白结合型，HB1801）治疗局部晚期鳞状非小细胞肺癌患者——一项随机对照Ⅱ期研究（BATTLE研究）讲者：张力中山大学肿瘤防治中心 979MO Plinabulin/Docetaxel vs. Docetaxel in 2L/3L EGFRwt NSCLC after Platinum Regimens (DUBLIN-3): Asian Subgroup Analysis 中文标题：Plinabulin/多西他赛对比多西他赛用于含铂方案治疗后二线/三线EGFR野生型非小细胞肺癌（DUBLIN-3）：亚洲亚组分析讲者：韩宝惠上海市胸科医院（上海交通大学医学院附属胸科医院） Mini Oral session 2： 976MO Vebreltinib in MET amplification-driven advanced non-small-cell lung cancer (NSCLC): results from phase 2 KUNPENG study 中文标题：伯瑞替尼治疗MET扩增驱动的晚期非小细胞肺癌：KUNPENGⅡ期研究结果讲者：吴一龙广东省人民医院 LBA8 Driver Gene–Specific ctDNA Monitoring as a Cost-Effective MRD Strategy in Resectable Stage III Driver-Mutant NSCLC: First Analysis of a Multicenter, Prospective Study (NCT06443684) 中文标题：基于驱动基因的ctDNA监测作为可切除Ⅲ期驱动基因突变非小细胞肺癌的高性价比MRD策略：一项多中心前瞻性研究（NCT06443684）的首次分析讲者：李子明上海市胸科医院（上海交通大学医学院附属胸科医院） 927MO Osimertinib (osi) before and after chemoradiotherapy (CRT) in patients (pts) with unresectable (UR) stage III EGFRm NSCLC: Phase 2 NEOLA study interim analysis (IA) 中文标题：奥希替尼在放化疗前、后用于不可切除Ⅲ期EGFR突变非小细胞肺癌患者：NEOLA Ⅱ期研究中期分析讲者：陈明中山大学肿瘤防治中心 903MO Neoadjuvant (neoadj) osimertinib (osi) ± chemotherapy (CT) vs CT alone in patients (pts) with resectable epidermal growth factor receptor-mutated (EGFRm) stage II–IIIB non-small cell lung cancer (NSCLC): patient-reported outcomes (PROs) from NeoADAURA 中文标题：在可切除Ⅱ至ⅢB期EGFR突变非小细胞肺癌患者中，新辅助奥希替尼联合或不联合化疗对比单独化疗：来自NEOADAURA研究的患者报告结局讲者：陈克能北京大学肿瘤医院胃肠道肿瘤 Proffered Paper session： 271O Final Analysis and Biomarker Evaluation of JUPITER-06: A Phase 3 Trial of Toripalimab Plus Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma 中文标题：JUPITER-06最终分析及生物标志物评估：一项特瑞普利单抗联合化疗治疗晚期或转移性食管鳞状细胞癌的Ⅲ期临床试验讲者：Yanxing Chen 中山大学肿瘤防治中心 LBA3 177Lu-DOTATATE Versus High-dose Long-acting Octreotide for Somatostatin Receptor-positive Advanced GEP-NETs: A Multicenter, Randomised, Open-Label, Positive-Controlled Phase III study 中文标题：177Lu-DOTATATE对比大剂量长效奥曲肽用于生长抑素受体阳性晚期胃肠胰神经内分泌肿瘤：一项多中心、随机、开放标签、阳性对照的Ⅲ期研究讲者：Yun Liang （广州） LBA4 WES-Powered MRD Navigation for Adjuvant therapy in Hepatocellular Carcinoma 中文标题：基于全外显子组测序的MRD动态监测指导肝细胞癌辅助治疗讲者：Shiqi Zhou（上海） Mini Oral session： 274MO 中文标题：来自Ⅲ期HIMALAYA研究的汇总疗效与安全性分析：中国大陆扩展队列，以及中国香港和中国台湾亚组的不可切除肝细胞癌患者接受tremelimumab联合度伐利尤单抗治疗的数据讲者：George K. K. Lau (中国香港) LBA5 Updated results from a phase 1 study of JS107, a claudin 18.2 (CLDN18.2)-targeting antibody-drug conjugate (ADC), in combination with toripalimab and chemotherapy as the first-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA) 中文标题：JS107（一种靶向Claudin 18.2的抗体药物偶联物）联合特瑞普利单抗和化疗作为晚期胃或胃食管结合部腺癌一线治疗的Ⅰ期研究更新结果讲者：阮丹云中山大学肿瘤防治中心 277MO Efficacy and safety of adebrelimab combined with S-1 plus oxaliplatin in neoadjuvant therapy for locally advanced gastric adenocarcinoma 中文标题：阿得贝利单抗联合S-1和奥沙利铂用于局部晚期胃腺癌新辅助治疗的疗效与安全性讲者：杨建军空军军医大学西京医院 198MO MK-1084 for KRAS G12C-mutated advanced colorectal cancer (CRC): Updated findings from KANDLELIT-001 中文标题：MK-1084治疗KRAS G12C突变晚期结直肠癌 (CRC)：KANDLELIT-001 研究的更新结果讲者：薛俊丽同济大学附属东方医院妇科肿瘤 Proffered Paper session: 601O From Slides to Signals: A Multimodal Deep Learning Framework Decoding Platinum Resistance in Ovarian Cancer 中文标题：从切片到信号：解码卵巢癌铂类耐药的多模态深度学习框架讲者：Enyu Tang (北京) 602O Efficacy and Safety of HLX43 (an anti-PD-L1 ADC) in Recurrent/Metastatic Cervical Cancer (CC): a Randomised, Multicentre, Phase 2 Study 中文标题：HLX43（一种抗PD-L1抗体药物偶联物）治疗复发性/转移性宫颈癌的疗效与安全性：一项随机、多中心、Ⅱ期研究讲者：Peng Xie （济南） 603O DB-1311/BNT324 (a novel B7H3 ADC) in patients with advanced cervical cancer or platinum-resistant recurrent ovarian cancer 中文标题：DB-1311/BNT324（一种新型B7H3抗体药物偶联物）在晚期宫颈癌或铂类耐药复发性卵巢癌患者中的应用研究讲者：Chih-Long Chang (中国台湾) Mini Oral session 607MO Iparomlimab and tuvonralimab (QL1706) vs zimberelimab for previously treated recurrent/metastatic cervical cancer (r/mCC): An unanchored matching-adjusted indirect comparison (MAIC) 中文标题：艾帕洛利托沃瑞利单抗（QL1706）对比赛帕利单抗用于既往治疗过的复发性/转移性宫颈癌（r/mCC）：一项非锚定匹配调整间接比较（MAIC）分析讲者：吕晓娟浙江省肿瘤医院 608MO Reduction of cell viability by immune-checkpoint inhibitor in co-cultured organoids derived from high-risk endometrial cancer patients pretreated with PARP inhibitor 中文标题：在经PARP抑制剂预处理的高危子宫内膜癌患者来源的共培养类器官中，免疫检查点抑制剂可降低细胞活力讲者：Wai Sun Chan （中国香港） 609MO Tisotumab vedotin vs investigator’s choice of chemotherapy as second- or third-line (2L/3L) treatment for Chinese patients (pts) with recurrent or metastatic cervical cancer (r/mCC) in innovaTV 301 中文标题：tisotumab vedotin对比研究者选择的化疗方案作为中国复发性或转移性宫颈癌患者二线或三线治疗：innovaTV 301研究讲者：安菊生中国医学科学院肿瘤医院 610MO Optimal adjuvant radiotherapy strategy for cervical cancer: a multi-center database cohort study 中文标题：宫颈癌最佳辅助放疗策略：一项多中心数据库队列研究讲者：Fang Bai （上海）泌尿肿瘤 Proffered Paper session: 487O Capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC): Phase 3 CAPItello-281 Chinese subgroup analysis 中文标题：Capivasertib联合阿比特龙对比安慰剂联合阿比特龙治疗PTEN缺陷原发转移性激素敏感性前列腺癌患者：Ⅲ期CAPItello-281研究中国亚组分析讲者：曾浩四川大学华西医院 488O MRI-targeted biopsy with index lesion ipsilateral or bilateral systematic biopsy in prostate cancer: a multicenter, paired, noninferiority, observational trial 中文标题：MRI靶向活检联合核心病灶同侧或双侧系统性活检在前列腺癌中的应用：一项多中心、配对、非劣效性、观察性试验讲者：Yongbing Cheng （南京） 540O Fruquintinib monotherapy as second-line (2L) treatment in locally advanced or metastatic renal cell carcinoma (RCC): results from phase 2 part of FRUSICA-2 中文标题：呋喹替尼单药作为局部晚期或转移性肾细胞癌的二线治疗：FRUSICA-2研究Ⅱ期部分结果讲者：Shanshan Wang （上海） Mini Oral session： 489MO A multicenter, single-arm, phase 2 trial of androgen deprivation therapy in combination with apalutamide in patients with high risk of recurrence after radical prostatectomy (ARES study) 中文标题：一项雄激素剥夺疗法联合阿帕他胺用于根治性前列腺切除术后高复发风险患者的多中心、单臂、Ⅱ期试验（ARES研究）讲者：Qing Zhang （南京） 490MO Niraparib (NIRA) and Abiraterone Acetate plus Prednisone (AAP) in Chinese Patients with breast cancer susceptibility gene (BRCA) altered metastatic castration-sensitive prostate cancer (mCSPC): Subgroup Analysis of the Phase 3 AMPLITUDE Trial 中文标题：尼拉帕利与醋酸阿比特龙联合泼尼松治疗中国乳腺癌易感基因突变转移性去势敏感性前列腺癌患者：Ⅲ期AMPLITUDE试验亚组分析讲者：Beihe Wang （上海） 541MO Efficacy and safety of disitamab vedotin combined with gemcitabine as neoadjuvant therapy for muscle-invasive bladder cancer: A multi-center, single-arm, phase II trial 中文标题：维迪西妥单抗联合吉西他滨作为肌层浸润性膀胱癌新辅助治疗的疗效与安全性：一项多中心、单臂、Ⅱ期试验讲者：Chunguang Yang （武汉） 542MO Efficacy and safety of disitamab vedotin (DV) combined with tislelizumab as adjuvant therapy after radical surgery for patients with HER2-expression upper tract urothelial carcinoma (UTUC): A single-arm, prospective, phase Ⅱ study 中文标题：维迪西妥单抗联合替雷利珠单抗作为HER2表达上尿路尿路上皮癌患者根治术后辅助治疗的疗效与安全性：一项单臂、前瞻性、Ⅱ期研究讲者：顾良友解放军总医院 547MO Efficacy and Safety of Toripalimab Combined with Lenvatinib as First-Line Treatment for Unresectable/Advanced Non–Clear Cell Renal Cell Carcinoma: A Prospective, Single-arm, Phase II trial 中文标题：特瑞普利单抗联合仑伐替尼作为不可切除/晚期非透明细胞肾细胞癌一线治疗的疗效与安全性：一项前瞻性、单臂、Ⅱ期试验讲者：Yaohui Wang （北京）头颈肿瘤 Proffered Paper session： 666O Exploration of the efficacy of nimotuzumab combined with induction chemotherapy in locally advanced nasopharyngeal carcinoma: A multicenter, prospective phase 3 study 中文标题：尼妥珠单抗联合诱导化疗在局部晚期鼻咽癌中的疗效探索：一项多中心、前瞻性Ⅲ期研究讲者：王孝深复旦大学附属眼耳鼻喉科医院 Mini Oral session： 669MO Long Term Overall Survival Follow-up of Toripalimab versus Placebo in Combination with Gemcitabine and Cisplatin as First-line Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma 中文标题：特瑞普利单抗对比安慰剂联合吉西他滨和顺铂作为复发或转移性鼻咽癌一线治疗的长期总生存随访结果讲者：陈秋燕中山大学肿瘤防治中心 670MO Efficacy and Safety of Liposomal Irinotecan plus Nimotuzumab in Immune Checkpoint Inhibitor–Refractory Recurrent or Metastatic Nasopharyngeal Carcinoma: A Single-arm, Open-label, Phase 2 trial 中文标题：脂质体伊立替康联合尼妥珠单抗治疗免疫检查点抑制剂难治性复发或转移性鼻咽癌的疗效与安全性：一项单臂、开放标签、Ⅱ期试验讲者：Shuiqing He （广州） 671MO Long-Term Outcomes of Reduced-Dose Radiotherapy in Patients with Epstein-Barr Virus DNA-Selected Stage III Nasopharyngeal Carcinoma: A 5-Year Follow-Up Secondary Analysis of a Phase II Trial 中文标题：基于EBV-DNA筛选的Ⅲ期鼻咽癌患者接受减剂量放疗的长期结果：一项Ⅱ期试验的5年随访二次分析讲者：郭珊珊中山大学肿瘤防治中心 672MO Efficacy of Immunotherapy Rechallenge in Locoregionally Advanced Nasopharyngeal Carcinoma After Progression on Prior Immunotherapy: A Real-Word Analysis 中文标题：局部晚期鼻咽癌既往免疫治疗进展后免疫治疗再挑战的疗效：一项真实世界分析讲者：Jiarui He （广州） 673MO Optimizing Induction Chemotherapy Cycles in Locally Advanced Nasopharyngeal Carcinoma: A Recursive Partitioning Risk Stratification Analysis 中文标题：局部晚期鼻咽癌诱导化疗周期数的优化：基于递归分割的风险分层分析讲者：Jie Yi Lin （广州） 674MO Neoadjuvant application of Pembrolizumab and Chemotherapy in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC): A Single-Arm, Single-Center Phase 2 Study 中文标题：帕博利珠单抗联合化疗在可切除局部晚期头颈部鳞状细胞癌中的新辅助应用：一项单臂、单中心、Ⅱ期研究讲者：Kai Wang （北京） 675MO A prospective, multi-center phase II study: Evaluating the efficacy and safety of pembrolizumab combined with chemotherapy as neoadjuvant therapy in laryngeal/hypopharyngeal squamous cell carcinoma (L/HPSCC) 中文标题：一项前瞻性、多中心Ⅱ期研究：评估帕博利珠单抗联合化疗作为喉/下咽鳞状细胞癌新辅助治疗的疗效与安全性讲者：陈晓红首都医科大学附属北京同仁医院 675MO Neoadjuvant chemo-immunotherapy with camrelizumab plus chemotherapy in resectable or potentially resectable locally advanced head and neck squamous cell carcinoma: an open-label, single-arm, phase II trial 中文标题：卡瑞利珠单抗联合化疗用于可切除或潜在可切除局部晚期头颈部鳞状细胞癌的新辅助化免联合治疗：一项开放标签、单臂、Ⅱ期试验讲者：苗素生哈尔滨医科大学附属肿瘤医院乳腺癌 LBA1 Analysis of Asian patients (pts) with HR+/HER2− early breast cancer (EBC) treated with ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI): 5-year outcomes from NATALEE 中文标题：在 NATALEE 研究中接受瑞波西利联合非甾体芳香化酶抑制剂治疗的HR+/HER2-早期乳腺癌亚洲患者的5年结局分析讲者：Yen-Shen Lu （中国台湾） 87MO Capivasertib (C) + paclitaxel (P) as first-line treatment of metastatic triple-negative breast cancer: The CAPItello-290 Phase III trial extended China cohort 中文标题：卡帕塞替尼联合紫杉醇作为转移性三阴性乳腺癌一线治疗：CAPItello-290 Ⅲ期试验中国扩展队列研究讲者：Wen Xia （广州） 89MO Phase I/Ib data of SMP-656: a novel Eribulin-based HER2 ADC in solid tumor 中文标题：SMP-656（一种基于艾日布林的新型HER2 ADC）治疗实体瘤的Ⅰ/Ⅰb期研究数据讲者：刘晓军复旦大学附属肿瘤医院 90MO Preliminary efficacy and safety of FDA022-BB05 in advanced/metastatic HER2 low breast cancer: Results from a phase 2 study 中文标题：FDA022-BB05 在晚期/转移性 HER2低表达乳腺癌中的初步疗效与安全性：一项Ⅱ期研究结果讲者：刘晓军复旦大学附属肿瘤医院 65MO Neoadjuvant HLX11 versus European Union (EU)-sourced pertuzumab in human epidermal growth factor receptor 2 (HER2)-positive, hormone receptor (HR)-negative early or locally advanced, breast cancer (BC): A double-blind, randomised phase 3 equivalence study 中文标题：HLX11 对比欧盟来源的帕妥珠单抗用于新辅助治疗HER2阳性、HR阴性早期或局部晚期乳腺癌：一项双盲、随机、Ⅲ期等效性研究讲者：Yaping Yang （广州） 1MO Association of genetic risk, DEHP exposure, and their interaction with breast cancer and breast cancer-related mortality 中文标题：遗传风险、DEHP暴露及其交互作用与乳腺癌及乳腺癌相关死亡率的关联讲者：Lijuan Tang （成都） 3MO Axillary Management Strategies in Breast Cancer Patients With ypN0 After Neoadjuvant Therapy 中文标题：新辅助治疗后达到ypN0的乳腺癌患者的腋窝处理策略讲者：Qingyao Shang （北京）新兴疗法及精准医学 Proffered Paper session: 158O A phase 1 first-in-human study of BPB-101, a novel triple functional bispecific antibody targeting GARP/TGF-β complex and PD-L1, in patients with locally advanced or metastatic solid tumors 中文标题：BPB-101（一种靶向GARP/TGF-β复合物及PD-L1的新型三功能双特异性抗体）在局部晚期或转移性实体瘤患者中的首次人体I期研究讲者：马宇翔中山大学肿瘤防治中心 159O First-in-human study of ES014, a bispecific antibody targeting CD39 and TGF-β as monotherapy in patients with advanced solid tumors. 中文标题：ES014（一种靶向CD39和TGF-β的双特异性抗体）单药治疗晚期实体瘤患者的首次人体研究讲者：Zhen Zhou （上海） Mini Oral session: LBA7 ProSight: the first prospective interventional trial of multi-cancer early detection (MCED) test among asymptomatic population in China 中文标题：ProSight：中国首个在无症状人群中进行的多癌种早期检测前瞻性干预性试验讲者：Miaoyan Wei （上海） 160MO BL-M07D1, a novel anti-HER2 antibody-drug conjugate (ADC), in subjects with metastatic HER2-mutant non-small cell lung cancer (NSCLC) 中文标题：BL-M07D1（一种新型抗HER2抗体药物偶联物）在转移性HER2突变非小细胞肺癌受试者中的研究讲者：Jinhui Xue （上海） 161MO Safety and tolerability of a novel PARP7 inhibitor QLS1103 in patients with advanced solid tumors: results from a phase 1 trial 中文标题：新型PARP7抑制剂QLS1103在晚期实体瘤患者中的安全性与耐受性：一项I期试验结果讲者：陈华军广东省人民医院 162MO A first-in-human (FIH), dose escalation study of HMPL-A83 (A83), an anti-CD47 monoclonal antibody (mAb) in patients (pts) with advanced solid tumors 中文标题：HMPL-A83（一种抗CD47单克隆抗体）在晚期实体瘤患者中的首次人体剂量递增研究讲者：郭晔同济大学附属东方医院 163MO First-in-human phase 1 study of the anti-TIGIT and PVRIG bispecific antibody as monotherapy or with sintilimab for advanced solid tumors 中文标题：抗TIGIT及PVRIG双特异性抗体单药或联合信迪利单抗治疗晚期实体瘤的首次人体I期研究讲者：Jinhui Xue （广州）支持和姑息治疗 740MO Enhancing Community Palliative Care in Advanced Cancer Using SUPPORT+: A Randomized Trial Subgroup Analysis in Older Adults 中文标题：利用SUPPORT+增强晚期癌症社区姑息照护：一项针对老年患者的随机试验亚组分析讲者：Wendy W. Chan （中国香港）文章来源：中国医学论坛报今日肿瘤，整理自2025 ESMO Asia官网。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

2025-12-01

·百度百家

下午5点02分，这一哆嗦，可能...@幸福小棉袄的动态

下午5点02分，这一哆嗦，可能要让40万散户今晚彻底失眠了。不是吓的，是乐的。恒瑞医药贴在公告栏里的那份文件，我捏着手机读了三遍。纸面轻飘飘的，可每个字砸在心上都发沉。阿得贝利单抗领着另外四款新药，齐齐拿到了临床试验批文。这阵仗像什么？像闷雷滚过雨季的云层，轰隆隆压着响动，雨还没下，地上的人已经仰着脖子等浇透。去年在《中国新药审评年度报告》里翻到过数据，能同时推进五条临床管线的本土企业，十个指头数得过来。现在恒瑞一把甩出五张牌，这不是摆摊叫卖，是掀开底牌亮家当。有人总嘀咕医药股温吞，像老牛拉破车。可2023年行业白皮书里写得明明白白：化药申报量跌了两成，生物药却逆势涨三成——这世道，吹泡泡的早歇菜了，能攥着专利铁砣的人才有资格坐庄。你看阿得贝利单抗瞄准的小细胞肺癌，全球三期临床刚登在《柳叶刀》上，客观缓解率硬生生拔高15%。旁边跟着的SHR-1701，啃的是PD-L1耐药这块硬骨头。这些名字念起来拗口，可它们背后蹲着多少患者的半夜叹息？我认识个江浙的药代，去年跑医院磨破十几双鞋底，他扯着嗓子说：“现在医生开口不问折扣，先拍论文问循证证据。” 创新药这赛道，早不是拼谁嗓门大。恒瑞在苏州生物医药产业园埋了六年的研发灶台，火苗终于窜上房梁了。当年他们立项双抗时，国内还没几个人敢碰双特异性抗体，现在临床批件啪嗒啪嗒往下掉，像熟透的银杏果砸在脑门上。明天九点半开盘，我猜交易员手心里都是汗。去年信达生物公布帕博利珠单抗联用数据时，板块单日蹦高七个点。这回五箭齐发，资金怕是要把自选列表点出火星子。不过你也别光盯着涨停板。临床试验批件只是入场券，后面还有Ⅰ期剂量爬坡的陡坡要爬，Ⅱ期盲态评审的迷雾要闯。好在恒瑞的研发费用像发面馒头似的胀到百亿量级，该备的干粮都塞满行囊了。等着看吧，这出戏才刚敲锣。你身边有押创新药的朋友吗？记得提醒他今晚定个闹钟——不是怕起晚，是怕激动得根本睡不着。

2025-11-30

·百度百家

恒瑞医药五款新药齐发，40万散户今夜无眠！

就在上周，恒瑞医药的一纸公告直接点燃了资本市场——阿得贝利单抗等5款新药同时拿到临床试验批件。这可不是普通进展，而是涉及KRAS抑制剂、ADC药物、免疫检查点抑制剂等多个前沿技术平台的集中爆发。更让人咋舌的是，这些药物累计研发投入已超过1.7亿元，其中仅阿得贝利单抗一款药的投入就接近10亿元。难怪有投资者调侃：“这哪里是公告，分明是业绩冲锋号！ ” 恒瑞医药这次获批临床的五款药物，覆盖了当前创新药研发最热门的赛道。 HRS-7058作为KRAS G12C抑制剂，直接瞄准了曾经“不可成药”的靶点，而全球同类药物去年销售额已接近5亿美元。更值得注意的是注射用SHR-A2102，这是一款靶向Nectin-4的ADC药物，同类产品Padcev在2024年全球销售额达到19.49亿美元。这些数据背后，是恒瑞医药对前沿靶点的精准卡位。临床试验批件的含金量，从研发投入就能看出端倪。贝伐珠单抗注射液虽然已是成熟产品，但恒瑞仍追加了3.65亿元研发资金；而针对PD-L1的阿得贝利单抗，累计投入更高达9.69亿元。这种持续加码的底气，来源于公司前三季度49.45亿元的研发费用支撑。有业内人士指出：“恒瑞的研发投入已超500亿元，这种规模在国内药企中绝无仅有。 ” 这波临床批件的特殊性在于，它们不是孤立事件。就在11月中旬，恒瑞医药还一次性获批了HRS-4642注射液等9项临床试验。短短半个月内，公司密集获得十余项临床批件，这种效率在监管趋严的背景下显得尤为突出。要知道，同期行业内有147个药物临床试验申请被撤回或否决，而恒瑞的撤回数量为零。市场关注度最高的当属阿得贝利单抗的新适应症拓展。该药早在2023年就已获批用于小细胞肺癌治疗，如今新增临床适应症，意味着其市场潜力将进一步释放。全球同类药物Atezolizumab、Durvalumab等去年合计销售额达96.48亿美元，这个赛道显然还有足够空间。从技术平台看，恒瑞正在构建多元化的创新矩阵。 ADC药物SHR-A2102与KRAS抑制剂HRS-7058代表的是完全不同的技术路径，但都指向同一个目标：攻克难治性肿瘤。特别是HRS-7058针对的KRAS G12C突变，在肺癌、结直肠癌中常见，但长期以来缺乏有效治疗方案。恒瑞医药的研发管线厚度由此可见一斑。根据2025年三季报，公司目前拥有100多个自主创新产品在临床开发阶段，400多项临床试验在全球推进。这种规模化的创新布局，使得单次临床批件不再是孤立事件，而是系统化产出的一部分。国际化战略也为这些新药提供了更广阔的想象空间。今年7月，恒瑞与GSK达成涉及12款创新药的合作，潜在价值高达120亿美元。而KRAS抑制剂等前沿靶点药物，正是跨国药企争相布局的焦点领域。有投资者指出：“恒瑞的临床进展不再只是国内故事，而是全球创新竞争力的体现。 ” 从资本市场反应看，五款新药同期获批的情况确实罕见。尤其是HRS-7058同时获得胶囊和片剂两种剂型的临床批件，为后续差异化竞争埋下伏笔。这种细节往往容易被忽略，但却可能成为未来市场竞争的关键变量。医药行业分析师指出，恒瑞此次获批的药物中，皮下注射剂型SHR-9839(sc)值得关注。该剂型能显著提升患者用药便利性，全球目前仅有1款同靶点药物获批。这种改良型创新看似微小，却可能成为临床推广的破局点。值得注意的是，恒瑞医药在前三季度已获得48个临床试验批件，其中4款产品被纳入突破性治疗品种。这种高频次的获批节奏，反映出公司研发管线已进入成果密集产出期。有机构投资者直言：“现在看恒瑞的公告得像追剧一样紧跟，稍不留神就错过重要剧情。 ” 与某些药企靠单一明星产品打天下不同，恒瑞医药的竞争力体现在多领域协同并进。从肿瘤免疫到代谢疾病，从ADC到小分子抑制剂，这种广度让竞争对手难以简单复制。正如一位行业专家所说：“恒瑞的可怕之处不在于某个产品多领先，而在于它能同时在十几个赛道保持竞争力。 ”#我的运动日常打卡# 恒瑞医药这次五箭齐发，展现的不仅是短期利好，更是中国创新药企从跟跑到并跑的实力跃迁。当临床试验批件成为常态化产出，当研发管线覆盖前沿靶点与临床需求，这家药企龙头正在重新定义行业竞争规则。或许正如投资者所言：“看懂恒瑞的临床批件，就读懂了中国医药创新的未来。 ”

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适应症	国家/地区	公司	日期
广泛期小细胞肺癌	中国	上海盛迪医药有限公司	2023-02-28

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适应症	最高研发状态	国家/地区	公司	日期
非小细胞肺癌	申请上市	中国	上海盛迪医药有限公司	2025-09-23
非小细胞肺癌	申请上市	中国	苏州盛迪亚生物医药有限公司	2025-09-23
晚期胆道癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2025-11-01
晚期宫颈癌	临床3期	中国	上海盛迪医药有限公司	2025-10-17
局部晚期宫颈癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2025-10-17
局部晚期宫颈癌	临床3期	中国	上海盛迪医药有限公司	2025-10-17
PD-L1阳性三阴性乳腺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2025-09-01
转移性胃食管结合部腺癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2025-08-18
肌层浸润性膀胱癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2025-04-25
晚期肝细胞癌	临床3期	中国	苏州盛迪亚生物医药有限公司	2024-10-28

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临床结果

适应症

分期

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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


NCT06146985 (ESMO2025)	临床2期	甲状腺癌	21	AdebrelimabFamitinib + AdebrelimabFamitinibab	淵鬱觸廠醖蓋鹽衊艱蓋(憲膚齋廠顧憲鏇憲遞艱) = 製淵醖遞繭鹽築齋簾築鏇糧鑰窪餘願餘築積獵 (積窪襯顧鹹簾憲齋窪壓 ) 更多	积极	2025-10-17
ChiCTR2300079126 (BRAIN-AF01, ESMO2025)	临床2期	PD-L1阳性肺癌一线 PD-L1 ≥50%	11	Adebrelimab 1200 mg IV Q3W with either famitinib or bevacizumab	淵積鏇顧餘齋蓋積齋觸(膚網鹽蓋膚餘積顧顧鹽) = 鹽鬱獵窪簾製網觸憲餘夢鹹範廠艱觸鬱鬱製醖 (鏇網遞顧窪糧膚廠鹽窪 ) 更多	积极	2025-10-17
NCT06418594 (ESMO2025)	临床2期	HER2 阴性乳腺癌 HER2-negative	7	ApatinibEtoposideAdebrelimab + ApatinibEtoposideAdebrelimab + ApatinibEtoposideAdebrelimab (HER2-negative breast cancer brain metastasis)	選築顧夢網餘鏇觸製鏇(選襯憲網網範獵顧鹽淵) = 願願窪繭壓衊繭淵衊壓夢艱齋壓製窪鹹顧壓衊 (顧構鹹壓壓築膚憲顧襯 ) 更多	积极	2025-10-17
NCT06475417 (ESMO2025)	临床2期	局部晚期胃食管交界处腺癌新辅助	27	Adebrelimab + DOS	蓋網選淵艱遞鬱衊窪範(醖淵簾願鬱窪鑰襯糧遞) = 製衊願蓋窪網獵願衊糧膚簾蓋衊網範製壓鹽顧 (築艱膚範範壓鏇製簾廠 ) 更多	积极	2025-10-17
ESMO2025	临床2期	局部晚期直肠癌新辅助	19	Short-course radiotherapy + Adebrelimab + CAPOX/mFOLFOX chemotherapy	鹹簾糧鏇淵繭衊壓願遞(構遞鬱繭範餘醖壓餘鏇) = 顧鹹觸願願網鏇簾遞衊遞簾鏇膚艱醖觸壓鹹製 (鹹獵構顧製艱網襯醖遞 ) 更多	积极	2025-10-17
NCT06251492 (RAPID, ESMO2025)	临床2期	转移性去势抵抗性前列腺癌	30	SBRT+adebrelimab (mCRPC)	廠衊糧鹹膚築鬱鏇築網(積憲網積糧膚製窪簾獵) = 繭膚壓餘糧繭繭構鹹繭鹽餘醖選築製顧糧構壓 (醖簾窪遞遞觸憲糧網淵, 34.7 ~ 70.8) 更多	积极	2025-10-17
NCT03736863 (CAP 02, ESMO2025)	临床2期	晚期食管鳞状细胞癌	25	ApatinibAdebrelimab + ApatinibAdebrelimab	構鬱壓築窪範衊蓋觸鏇(積窪淵鬱膚築餘築廠積) = 鑰壓遞艱顧憲鑰糧窪餘衊壓構鹹顧餘顧鹽製窪 (繭醖淵獵觸襯鏇願鬱齋 ) 更多	积极	2025-10-17
NCT06306560 (ESMO2025)	临床2期	广泛期小细胞肺癌一线	20	Adebrelimab + Famitinib + Chemotherapy (safety run-in phase (6 patients))	鹹夢糧製構糧蓋壓蓋壓(艱鹽構製衊齋遞廠蓋鹽) = 夢積選襯膚網壓膚範製願構廠窪繭遞構鹽網築 (窪築簾鹹糧觸鬱遞齋醖, 50.4 ~ 95.9) 更多	积极	2025-10-17
ChiCTR2300074620 (ESMO2025)	临床2期	局部晚期宫颈癌新辅助	20	Adebrelimab + Paclitaxel + Cisplatin/Carboplatin	齋廠鏇簾網遞簾觸餘鹹(蓋憲繭鏇繭願廠鏇簾壓) = 淵遞艱襯範醖鏇範觸獵淵衊襯餘簾簾鑰鑰繭範 (繭鹽網衊獵觸艱繭壓鑰 ) 更多	积极	2025-10-17
WCLC2025	N/A	局部晚期不可切除癌新辅助	9	Adebrelimab + nab-paclitaxel + carboplatin	蓋顧網鹹構憲夢鹹製簾(蓋鏇觸艱範糧餘蓋襯襯) = 糧觸齋網夢壓遞獵築顧範憲窪艱築願淵廠簾艱 (壓齋淵齋繭蓋鏇遞鏇願 ) 更多	积极	2025-09-09