The aim of this research study is to evaluate the effectiveness and safety of a combination of immunotherapy, using a drug called toripalimab, with chemotherapy drugs, Carboplatin and Docetaxel, as a possible treatment before surgery for sinonasal cancers.
The names of the study drugs used in this research study are:
* Toripalimab (a type of monoclonal antibody)
* Carboplatin (a type of antineoplastic agent)
* Docetaxel (a type of antineoplastic agent)
* Cisplatin (a type of antineoplastic agent)

开始日期2025-10-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06682780

/ Not yet recruiting临床1/2期

An Open-label, Dose-escalation, and Dose-expansion Phase I/II Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Efficacy of LM-2417 for Injection Alone or in Combination With Other Antitumor Agents in Patients With Advanced Solid Tumors

This study is to assess the safety and tolerability, obtain the recommended phase 2 dose(RP2D)/or Maximum Tolerated Dose (MTD) for LM-2417 as a single agent or in combination with other anti-tumour agents in subjects with advanced solid tumours.

开始日期2025-06-05

申办/合作机构

礼新医药科技（上海）有限公司

NCT06912711

/ Recruiting临床2期IIT

Toripalimab Combined With Nimotuzumab Induction and Adjuvant Therapy for Resectable Local Recurrent Nasopharyngeal Carcinoma：A Single-arm, Phase II Clinical Tria

Investigators target recurrent nasopharyngeal carcinoma that can be resected surgically: rT1, rT2 (tumor confined to the surface of the parapharyngeal space, greater than 0.5cm from the internal carotid artery), rT3 (confined to the floor of the sphenoid sinus, greater than 0.5cm from the internal carotid artery/cavernous sinus) (AJCC 8th stage), A single-arm, phase II clinical trial was designed to investigate the efficacy and safety of triplizumab combined with nituzumab in induction and adjuvant treatment of operable local recurrent nasopharyngeal carcinoma.

开始日期2025-05-16

申办/合作机构

中山大学

100 项与特瑞普利单抗相关的临床结果

登录后查看更多信息

100 项与特瑞普利单抗相关的转化医学

登录后查看更多信息

100 项与特瑞普利单抗相关的专利（医药）

登录后查看更多信息

2,393

项与特瑞普利单抗相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Cost-effectiveness of PD-1 inhibitors combined with chemotherapy for first-line treatment of oesophageal squamous cell carcinoma in China: a comprehensive analysis

Article

作者: Zhang, Lingli ; Xu, Kai ; Yu, Man ; Lin, Yingtao ; Li, Xin ; Su, Dan ; Shang, Jingjing ; Sun, Qingli ; Gong, Jinhong ; Qian, Xiaodan

BACKGROUND:

Programmed death-1 (PD-1) inhibitors combined with chemotherapy have become a standard first-line treatment for advanced oesophageal squamous cell carcinoma (ESCC). Given the high costs associated with immunotherapy, evaluating the cost-effectiveness of different PD-1 inhibitors in the Chinese healthcare setting is essential for guiding treatment decisions and policy development.

METHODS:

A cost-effectiveness analysis was conducted comparing six PD-1 inhibitors-sintilimab, toripalimab, tislelizumab, camrelizumab, serplulimab, and pembrolizumab-combined with chemotherapy for first-line treatment of advanced ESCC. A partitioned survival model was used to calculate incremental cost-effectiveness ratios (ICERs) from healthcare system perspective, with a willingness-to-pay (WTP) threshold set at $36,598.19 per quality-adjusted life year (QALY). Sensitivity analyses were performed to evaluate the robustness of the results.

RESULTS:

The ICERs for toripalimab, camrelizumab, pembrolizumab, serplulimab, sintilimab, and tislelizumab were $32,356.79/QALY, $48,410.64/QALY, $312,743.54/QALY, $121,200.84/QALY, $29,663.42/QALY, and $35,304.33/QALY, respectively. Sintilimab, toripalimab, and tislelizumab were below the WTP threshold. Among all regimens, the top three in life years (LYs) gained were toripalimab, serplulimab, and tislelizumab. Sensitivity analysis showed that utility values and drug prices were key factors influencing ICERs. Probabilistic analysis indicated that toripalimab, sintilimab, and tislelizumab had the highest probabilities of being cost-effective, at 83.1%, 81.4%, and 70.0%, respectively.

CONCLUSION:

Sintilimab, toripalimab, and tislelizumab are the most cost-effective PD-1 inhibitors when combined with chemotherapy for the first-line treatment of advanced ESCC in China, with ICERs below the WTP threshold. While all six PD-1 inhibitors demonstrated clinical benefits, pembrolizumab and serplulimab were less favourable from a cost-effectiveness standpoint. Sensitivity analysis confirmed that drug prices and utility values are significant determinants of cost-effectiveness.

2025-12-01·Journal of Gastrointestinal Cancer

90Y-Transarterial Radioembolization Combined with Immune Checkpoint Inhibitors in Hepatocellular Carcinoma: A Systematic Review

Review

作者: Shobeiri, Parnian ; Lewandowski, Robert J ; Fowler, Kathryn J ; Behnoush, Amir Hossein ; Hosseini Shabanan, Sedighe ; Haghshomar, Maryam

BACKGROUND:

Transarterial radioembolization with yttrium-90 (⁹⁰Yt-TARE) and immune checkpoint inhibitors (ICIs) are emerging as treatment modalities for intermediate to advanced hepatocellular carcinoma (HCC) based on randomized controlled trials. Herein, we systematically reviewed the published literature on the effects of ⁹⁰Yt-TARE and ICIs combined on clinical outcomes of HCC.

METHODS:

Medical databases of PubMed, Embase, and Cochrane Library were systematically searched for all studies assessing the use of concomitant immunotherapy of ICI with TARE in patients with HCC. Patient characteristics, treatment protocols, treatment outcomes, treatment adverse events, and survival outcomes were extracted after the screening phase. The primary outcomes were overall survival (OS) and patient-free survival (PFS), while the secondary outcomes were imaging objective response (OR) and adverse events.

RESULTS:

Among 3432 reviewed, ten studies were included in this systematic review, including four randomized controlled trials and six retrospective studies. These consisted of 413 patients with HCC, and seven studies included patients with Child-Pugh A or B7 scores. Most studies allowed advanced or intermediate HCC stages, but only two specified BCLC stages (B and C). Median tumor sizes ranged from 56 to 78.5 mm. Various agents with different administration schedules were used as ICIs for immunotherapy by different studies for the combination of ⁹⁰Yt-TARE with ICIs. Median OS ranged from 16.2 to 27 months between different studies while the PFS also ranged from 5.6 to 13.3 months. The OR rates according to imaging-based response assessments were reported between 31 and 89%, and the incidence rate of any grade toxicities was between 50 and 80%.

CONCLUSION:

Concomitant treatment with ⁹⁰Yt-TARE and ICIs has shown promising results in the treatment of patients with HCC. Further studies are required to reach a consensus on the optimal treatment protocol and the outcome of these treatments for patients with intermediate to advanced HCC.

2025-06-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Efficacy and safety of targeted therapy and immunotherapy in advanced vulvar squamous cell carcinoma: A scoping review

Review

作者: Arenhardt, Martina Parenza ; de Andrade, Diocesio Alves Pinto ; Dos Santos, Marcela Bonalumi ; de Melo, Andréia Cristina ; da Silva, Jessé Lopes ; Gomes, Larissa Müller ; Giannecchini, Giovanna Vieira

INTRODUCTION:

Vulvar squamous cell carcinoma (VSCC) is a rare gynecological tumor with limited treatment options for advanced stages. Current chemotherapy, adapted from cervical cancer protocols, often results in poor outcomes. This scoping review evaluates the efficacy and safety of immunotherapy and targeted therapies in advanced VSCC.

MATERIAL AND METHODS:

After extensive assessment, examination, and curation of relevant literature data, eight trials focused on immunotherapy or targeted therapy for advanced, recurrent, or metastatic VSCCs were identified and selected. The findings have been compiled and synthesized into a narrative overview, adhering to the PRISMA-ScR guidelines.

RESULTS:

The study analyzed four unpublished and four published trials, evaluating the efficacy and safety of immunotherapy or targeted therapy for VSCCs. Pembrolizumab was assessed in the KEYNOTE-028 and KEYNOTE-158 trials, showing objective response rates (ORRs) of 6 % and 10.9 %, respectively, and median overall survival (OS) between 3.8 and 6.2 months. CheckMate 358 reported a 20 % ORR for nivolumab. Combination strategies (ipilimumab plus nivolumab and pembrolizumab plus vorinostat) demonstrated efficacy with median OS of 7.6 and 17.5 months, respectively. Toripalimab showed an ORR of 33.3 %. Safety profiles were generally manageable, with common adverse events like fatigue and gastrointestinal disorders. Serious adverse events included grade 5 immune-related hepatitis and chronic kidney disease.

CONCLUSION:

Immunotherapy may be considered an option for VSCCs in the second-line setting. Despite the limited research on targeted therapies for VSCCs, combination approaches with immunotherapy demonstrate promising potential. Prioritizing the identification of biomarkers that predict responses to immune checkpoint inhibitors is essential.

1,611

项与特瑞普利单抗相关的新闻（医药）

19 小时之前

·医药速览

2025ASCO肺癌口头汇报的重磅研究 495

美国临床肿瘤学会（ASCO）2025年会已于昨日公布完整日程。大会时间：5.30-6.3（The abstract will be released to the public on 2025年5月23日 GMT+8 05:00详细摘要内容5月23号公布，大概是会前一周公布）2025 ASCO：ADC、双抗/多抗，有哪些看点？（附一览表）整个会议共接收6339篇摘要，其中壁报Poster展示合计2492篇；Oral和Rapid oral各 212篇、206篇等。单纯摘要发表（publication only）3379篇；肺癌的口头汇报研究整理如下：小细胞肺癌LBA8008Tarlatamab对比化疗（CTx）作为小细胞肺癌（SCLC）二线（2L）治疗：III期DeLLphi-304主要分析。Abstract #8006Lurbinectedin（lurbi）+ 阿替利珠单抗（atezo）作为广泛期小细胞肺癌（ES-SCLC）一线（1L）维持治疗（tx）：III期IMforte试验主要结果。Abstract #3002（中山大学肿瘤防治中心黄岩教授）Iza-Bren（BL-B01D1）（一种EGFR x HER3双特异性抗体药物偶联物（ADC））在局部晚期或转移性小细胞肺癌（SCLC）患者中的I期研究。Abstract #LBA8005放化疗（CRT）后阿替利珠单抗（atezo）延长局限期（LS）小细胞肺癌（SCLC）生存期的随机II期试验。Abstract #8013Lurbinectedin联合阿替利珠单抗作为晚期小细胞肺癌二线治疗的安全性和有效性：2SMALL I/II期研究（NCT04253145）结果。Abstract #8014ADRIATIC试验中早期进展者（EPs）与长期无进展生存者（LTPs）的临床和分子特征：局限期小细胞肺癌（LS-SCLC）同步放化疗（cCRT）后巩固度伐利尤单抗（D）对比安慰剂（P）的III期研究。围术期/早期肺癌Abstract #8009可切除非小细胞肺癌（R-NSCLC）患者术后MRD状态与术前ctDNA动态、基因组突变及临床结局的关联：III期AEGEAN试验。Abstract #LBA8000CheckMate 816中新辅助纳武利尤单抗（NIVO）+化疗（chemo）治疗可切除NSCLC患者的总生存期（OS）。Abstract #8001新辅助奥希替尼（osi）±化疗（CT）对比单纯化疗治疗可切除EGFR突变（EGFRm）NSCLC：NeoADAURA。Abstract #LBA8010CheckMate 77T中可切除NSCLC患者围手术期纳武利尤单抗（NIVO）对比安慰剂（PBO）的更新生存和生物标志物分析。晚期/局部晚期肺癌Abstract #8514Benmelstobart联合化疗序贯安罗替尼一线治疗局部晚期或转移性鳞状非小细胞肺癌（sq-NSCLC）的III期研究。Abstract #LBA8502CAMPASS：Benmelstobart联合安罗替尼对比帕博利珠单抗（pembro）一线治疗晚期NSCLC的随机、单盲、多中心III期研究。Abstract #8516免疫化疗每日时机对NSCLC患者无进展生存期（PFS）和总生存期（OS）影响的随机试验。Abstract #8500KRYSTAL-7研究II期部分：Adagrasib（ADA）联合帕博利珠单抗（PEMBRO）一线治疗晚期/转移性KRASG12C突变NSCLC。Abstract #8012InTRist：诱导特瑞普利单抗（toripalimab）+化疗序贯同步放化疗及巩固特瑞普利单抗治疗不可切除III期NSCLC的随机II期初步结果。ADC或免疫联合ADCAbstract #8507（中山大学肿瘤防治中心张力教授）Sacituzumab tirumotecan（sac-TMT）治疗既往经治的晚期EGFR突变NSCLC：随机OptiTROP-Lung03研究结果。Abstract #2005Patritumab deruxtecan（HER3-DXd）治疗活动性脑转移（BM）（乳腺癌和NSCLC）及晚期实体瘤软脑膜转移（LMD）：TUXEDO-3 II期试验。Abstract #8501TROPION-Lung02：Dato-DXd联合帕博利珠单抗（pembro）±铂类化疗（Pt-CT）一线治疗晚期NSCLC。双抗ADCAbstract #3001（中山大学肿瘤防治中心杨云鹏教授）Iza-Bren（BL-B01D1）（一种EGFR x HER3双特异性抗体药物偶联物（ADC））在驱动基因变异（非经典EGFR突变）的晚期/转移性NSCLC患者中的I期研究。双抗（进行中研究）Poster Bd #135bHARMONi-3：依沃西单抗（ivonescimab）+化疗对比帕博利珠单抗（pembro）+化疗一线治疗转移性NSCLC的随机III期研究。原始英文的筛选：小细胞肺癌：LBA8008Tarlatamab versus chemotherapy (CTx) as second-line (2L) treatment for small cell lung cancer (SCLC): Primary analysis of Ph3 DeLLphi-304.Abstract #8006Lurbinectedin (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.Abstract #3002 （中肿黄岩教授）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).Abstract #LBA8005Randomized phase II trial investigating whether atezolizumab after chemoradiotherapy (CRT) prolongs survival in limited stage (LS) small cell lung cancer (SCLC).Abstract #8013Safety 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).Abstract #8014Clinical 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).围术期早期肺癌：Abstract #8009Association 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.Abstract #LBA8000Overall survival with neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) in patients with resectable NSCLC in CheckMate 816.Abstract #8001Neoadjuvant (neoadj) osimertinib (osi) ± chemotherapy (CT) vs CT alone in resectable (R) epidermal growth factor receptor-mutated (EGFRm) NSCLC: NeoADAURAAbstract #LBA8010Perioperative nivolumab (NIVO) vs placebo (PBO) in patients (pts) with resectable NSCLC: updated survival and biomarker analyses from CheckMate 77T.晚期局部晚期肺癌：Abstract #8514Phase 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).Abstract #LBA8502CAMPASS: 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.Abstract #8516Randomized trial of relevance of time-of-day of immunochemotherapy for progression-free and overall survival in patients with non-small cell lung cancer.Abstract #8500First-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.Abstract #8012The 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).ADC或免疫联合ADC：Abstract #8507（中肿张力教授）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.Abstract #2005Patritumab deruxtecan (HER3-DXd) in active brain metastases (BM) from metastatic breast (mBC) and non–small cell lung cancers (aNSCLC), and leptomeningeal disease (LMD) from advanced solid tumors: Results from the TUXEDO-3 phase II trial.Abstract #8501TROPION-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).双抗ADC：Abstract #3001（中肿杨云鹏教授）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.双抗进行中研究：Poster Bd #135bA randomized phase 3 study of ivonescimab plus chemotherapy versus pembrolizumab plus chemotherapy for the first-line treatment of metastatic non–small cell lung cancer: HARMONi-3.推文用于传递知识，如因版权等有疑问，请于本文刊发30日内联系医药速览。原创内容未经授权，禁止转载至其他平台。有问题可发邮件至yong_wang@pku.edu.cn获取更多信息。©2021 医药速览保留所有权利往期链接“小小疫苗”养成记 | 医药公司管线盘点人人学懂免疫学| 人人学懂免疫学（语音版）综述文章解读 | 文献略读 | 医学科普|医药前沿笔记PROTAC技术| 抗体药物| 抗体药物偶联-ADC核酸疫苗 | CAR技术| 化学生物学温馨提示医药速览公众号目前已经有近12个交流群（好学，有趣且奔波于医药圈人才聚集于此）。进群加作者微信（yiyaoxueshu666）或者扫描公众号二维码添加作者，备注“姓名/昵称-企业/高校-具体研究领域/专业”，此群仅为科研交流群，非诚勿扰。简单操作即可星标⭐️医药速览，第一时间收到我们的推送①点击标题下方“医药速览” ②至右上角“...” ③点击“设为星标

临床结果ASCO会议抗体药物偶联物临床3期临床2期

2025-05-21

·医学新视点

樊嘉院士团队领衔，生存期延长近6个月！多项指标改善，肝癌一线治疗策略再添新选择

大多数肝细胞癌患者在首次就诊时已处于疾病晚期，失去可手术切除的机会，而接受根治性手术的患者中，仍有70%可能在术后5年出现疾病进展或复发。近10多年来，索拉非尼一直是晚期肝细胞癌的一线靶向标准用药，而随着临床对肿瘤免疫学的深入探索，以免疫检查点抑制剂为基础的联合治疗模式在肝细胞癌的治疗中不断获得新突破，进一步提升了肝细胞癌患者的临床获益。当前，PD-1/PD-L1抑制剂联合抗血管生成药物的方案已是肝细胞癌的一线治疗策略，肝细胞癌患者有多种可选择的用药组合方案，但考虑到肝细胞癌的高发病率和高死亡率，以及不同国家和地区治疗方案的差异性，临床仍需探索更多肝细胞癌的一线治疗策略，以满足患者的未竟需求。近日，由复旦大学附属中山医院樊嘉院士团队领衔的HEPATORCH试验结果发表于《柳叶刀》子刊The Lancet Gastroenterology & Hepatology，该研究结果表明，相比于靶向标准用药，PD-1抑制剂特瑞普利单抗联合VEGF抑制剂贝伐珠单抗作为肝细胞癌的一线治疗策略，显著延长了肝细胞癌患者的中位无进展生存期（PFS，5.8个月 vs. 4.0个月）和总生存期（OS，20个月 vs. 14.5个月），安全性可控。文章表示，基于该方案所展示出的良好抗肿瘤疗效，中国国家药品监督管理局（NMPA）已批准该方案用于不可切除或转移性肝细胞癌的一线治疗。截图来源：The Lancet Gastroenterology & HepatologyHEPATORCH试验是一项随机、开放标签、多中心、活性药物对照、3期临床试验，纳入年龄18~75岁的肝细胞癌患者326例。研究人员将符合入组要求的患者以1：1的比例随机分配接受以下治疗：联合治疗组（162例）：特瑞普利单抗（240 mg，静脉注射，每3周一次）+贝伐珠单抗（15 mg/kg，静脉注射，每3周一次）；标准治疗组（164例）：口服索拉非尼，每日2次。该研究共同主要研究终点为经独立审查委员会（IRC）根据实体瘤疗效评价标准1.1版（RECIST 1.1）评估确认的PFS和OS。截至2024年5月31日（也是OS最终分析截止时间），大多数患者已停止治疗，其中联合治疗组和标准治疗组分别有93%（151/162）和97%（159/164）的患者停止治疗，主要原因为疾病进展。截至2022年8月10日（PFS主要分析截止时间），中位随访时间为9.4个月，联合治疗组和标准治疗组分别有63%（102/162）和68%（111/164）的患者出现疾病进展或死亡。结果显示，相比于标准治疗组，联合治疗组的中位PFS显著更长（5.8个月 vs. 4.0个月），联合治疗组患者发生疾病进展或死亡风险降低了31%（HR=0.69，95%CI：0.53~0.91，P=0.0086）。联合治疗组和标准治疗组6个月PFS率分别为48.7%和28.0%；1年PFS率分别为26.9%和13.1%。在不同性别、年龄等亚组中也观察到了类似的结果。▲联合治疗组（蓝色）和标准治疗组（红色）PFS变化情况对比（图片来源：参考文献[1]）截至2024年5月31日，中位随访时间为16.4个月，联合治疗组和标准治疗组分别有64%（104/162）和77%（126/164）患者死亡。相比于标准治疗组，联合治疗组的中位OS显著更长（20个月 vs. 14.5个月），联合治疗组死亡风险降低了24%（HR=0.76，95%CI：0.58~0.99，P=0.039）。联合治疗组和标准治疗组1年OS率分别为64.7%和55.5%；2年OS率分别为41.7%和34.1%。在不同性别、年龄等亚组中也观察到了类似的结果。▲联合治疗组（蓝色）和标准治疗组（红色）OS变化情况对比（图片来源：参考文献[1]）次要终点方面，无论是IRC以RECIST 1.1标准还是改良RECIST标准评估的相关指标，联合治疗组均优于标准治疗组。以RECIST 1.1标准为例，联合治疗组客观缓解率为25%（41/162），高于标准治疗组的6%（10/164）；联合治疗组疾病控制率更高[71%（115/162） vs. 65%（107/164）]；中位至疾病进展时间更长（6.9个月 vs. 4.1个月）。安全性方面，联合治疗组和标准治疗组分别有98%（158/162）和99%（162/164）患者在治疗期间至少发生一次不良事件，主要为高血压、血小板降低、消化道出血等。两组分别有6%（9/162）和4%（7/164）的患者出现5级不良事件，发生率类似，主要为意识水平降低、多器官功能障碍等。研究者判断联合治疗组5级不良事件与特瑞普利单抗用药无关。此外，联合治疗组有23%（37/162）的患者发生了免疫相关不良事件，其中6%（10/162）为3级及以上，主要为口腔炎。安全性与既往相关研究相一致，未发现新的安全性信号。文章表示，本次研究开始时，靶向标准用药仍是晚期肝细胞癌的主要一线治疗策略，当时在中国尚未有PD-1/PD-L1抑制剂与抗血管生成药物联用的方案获批用于治疗晚期肝细胞癌。总之，研究结果再次证实了PD-1/PD-L1抑制剂联合抗血管生成药物作为肝细胞癌一线治疗策略具有良好的协同效应，可显著延长患者中位PFS和OS，值得临床关注。点击文末“阅读原文/Read more”，即可访问The Lancet Gastroenterology & Hepatology官网阅读完整论文。推荐阅读欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。参考资料[1] Yinghong Shi, Guohong Han, Jian Zhou, et al. Toripalimab plus bevacizumab versus sorafenib as first-line treatment for advanced hepatocellular carcinoma (HEPATORCH): a randomised, open-label, phase 3 trial. Published Online May 20, 2025. Lancet Gastroenterol Hepatol. https://doi.org/10.1016/S2468-1253(25)00059-7[2]国际肝胆胰协会,中国分会中华医学会外科学分会肝脏外科学组,中国临床肿瘤学会(CSCO)肝癌专家委员会,陈孝平,夏锋.肝细胞癌免疫联合治疗多学科中国专家共识(2023版)[J].中华消化外科杂志,2023,22(3):293-315.[3]梁军, 李丽. 肝癌免疫治疗策略的进展与思考 [J] . 中华消化外科杂志, 2021, 20(2) : 184-190. DOI: 10.3760/cma.j.cn115610-20201228-00809.免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医学新视点」微信公众号留言联系。如有其他合作需求，请联系wuxi_media@wuxiapptec.com分享，点赞，在看，传递医学新知

2025-05-17

·石药集团

石药集团四项创新药研究成果入选美国临床肿瘤学会(ASCO)

5月30日至6月3日，一年一度的美国临床肿瘤学会年会(ASCO)将在美国芝加哥召开。石药集团在本届ASCO上将展示五个在研产品的四项最新临床试验进展：重组人源化抗EGFR单克隆抗体JMT101联合治疗3线及以上结直肠癌的II期临床研究：口头报告(编号：LBA3516)该项研究是由复旦大学附属中山医院许剑民教授牵头开展的一项多中心、随机、对照、开放性II期临床试验，旨在评估JMT101联合伊立替康和SG001对比JMT101联合伊立替康对比瑞格菲尼单药用于治疗3线及以上RAS/BRAF野生型，非dMMR/MSI-H结直肠癌的有效性、安全性、药代动力学特征和免疫原性。JMT101作为石药集团下属津曼特生物科技有限公司自主研发的1类新药，是一种重组人源化抗 EGFR 单克隆抗体。体外实验数据显示JMT101与人EGFR的亲和力约为西妥昔单抗的7倍，且JMT101与西妥昔单抗具有相似的抗体依赖性细胞介导的细胞毒作用（ADCC）和补体依赖的细胞毒作用（CDC）效应。既往临床研究显示JMT101联合奥希替尼在 EGFR 20 号外显子插入突变阳性非小细胞肺癌中，尤其是未经治疗的中枢神经系统转移患者，显示出良好疗效。Cx43半通道的单克隆抗体激动剂ALMB-0168治疗晚期骨肉瘤的I/II期研究（ACE研究）：入选口头报告(编号：11509)ACE研究是由中山大学附属第一医院沈靖南教授牵头开展的一项多中心、开放标签、单臂I/II期试验，旨在评估ALMB-0168在标准治疗失败后骨肉瘤患者中的安全性、耐受性、药代动力学特征和初步疗效。该研究数据此前已于2023年美国临床肿瘤学会（ASCO）年会以壁报形式首次公布，并于近期完成扩展队列分析。ALMB-0168是由石药集团美国子公司AlaMab Therapeutics Inc.自主研发的全球首款靶向Cx43半通道的单克隆抗体激动剂，它是一种人源化IgG4单克隆抗体，靶向骨细胞中高表达的Connexin 43（Cx43）半通道蛋白。Cx43是缝隙连接蛋白家族成员，在骨代谢和肿瘤微环境中发挥关键作用。ALMB-0168通过特异性结合Cx43半通道，激活其开放状态，促使细胞内ATP等关键物质释放至胞外环境，抑制CD4+ CD8+ T细胞转化为Treg细胞，从而增强肿瘤微环境当中T细胞抗肿瘤能力，抑制骨肉瘤原发灶及转移灶的生长与迁移。骨肉瘤是青少年最常见的恶性骨肿瘤，复发或转移后缺乏有效治疗手段。ALMB-0168良好的安全性和疗效为标准治疗失败后复发难治骨肉瘤的患者提供了有潜力的治疗新选择。并且，结合在骨肿瘤中作用机制和良好的临床研究数据，ALMB-0168取得了肿瘤骨转移适应症的I/II临床研究试验许可。EGFR ADC SYS6010+ATM抑制剂SYH2051联合治疗胃肠道肿瘤的首次人体试验：壁报(编号：P352)该项研究是由福建省肿瘤医院林榕波教授牵头开展的一项单中心、开放性、非随机临床试验，旨在评估SYS6010 联合 SYH2051对EGFR表达晚期胃肠道肿瘤患者的安全性、耐受性和初步疗效。抗肿瘤1类新药SYS6010是一种EGFR抗体-偶联药物，其与肿瘤细胞表面的EGFR受体结合后，通过内吞作用进入到细胞内，在溶酶体内被蛋白酶降解，释放毒素小分子JS-1(新型拓扑异构酶I抑制剂)，JS-1和DNA形成稳定复合物，诱导DNA损伤，进而导致细胞凋亡，且发挥旁观效应非特异性杀伤周围肿瘤组织细胞。SYH2051是石药集团开发的专利化合物，其可选择性靶向抑制ATM蛋白激酶及其下游信号蛋白CHK2和KAP1的磷酸化，延迟DNA双链断裂修复，导致持续的DNA双链断裂和ATM介导的细胞周期阻滞，从而阻止肿瘤细胞增殖。临床前药效学研究显示，SYS6010联合SYH2051在非小细胞肺癌动物模型上显示出协同抗肿瘤作用。在该项临床研究中，SYS6010联合SYH2051在EGFR表达晚期胃肠道肿瘤中显示出初步抗肿瘤活性，尤其是在胃癌患者中。紫杉醇阳离子脂质体治疗晚期实体瘤（动脉灌注化疗）IIT：在线发表(e15546)该项研究是浙江省丽水市中心医院纪建松教授牵头开展的一项单臂剂量递增和扩展的IIT研究，旨在评估XELOX方案联合紫杉醇阳离子脂质体经导管动脉灌注给药在肝转移瘤受试者中一线治疗的安全性、耐受性，药代动力学特征以及初步的疗效。肝动脉灌注化疗（HAIC）联合全身治疗能更有效地控制肝脏局部肿瘤进展。注射用紫杉醇阳离子脂质体（HA131）通过细胞毒性作用和阳离子脂质体靶向带负电荷的肿瘤新生血管内皮细胞，阻断营养供应，诱导肿瘤细胞凋亡，从而发挥双重抗肿瘤作用机制。初步的研究结果显示，HA131肝动脉灌注化疗与全身治疗的联合应用显示了可控的安全性和令人鼓舞的疗效，根据RECIST v1.1标准，在15例可评估疗效的结直肠癌肝转移患者中，ORR为86.7% (95% CI: 59.5%-98.3%)（1例完全缓解，12例部分缓解），DCR为100% (95% CI: 78.2%-100%)，值得进一步探索在结直肠癌肝转移患者中与系统性治疗的联合应用。【声明】1、本新闻旨在分享研究进展信息，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。

ASCO会议临床结果临床1期临床2期

100 项与特瑞普利单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC	DB15043

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
转移性黑色素瘤	中国	上海君实生物医药科技股份有限公司	2025-04-22
不可切除的黑色素瘤	中国	上海君实生物医药科技股份有限公司	2025-04-22
晚期肝细胞癌	中国	上海君实生物医药科技股份有限公司	2025-03-18
转移性食管鳞状细胞癌	欧盟	-	2024-09-19
转移性食管鳞状细胞癌	冰岛	-	2024-09-19
转移性食管鳞状细胞癌	列支敦士登	-	2024-09-19
转移性食管鳞状细胞癌	挪威	-	2024-09-19
鼻咽肿瘤	欧盟	-	2024-09-19
鼻咽肿瘤	冰岛	-	2024-09-19
鼻咽肿瘤	列支敦士登	-	2024-09-19
鼻咽肿瘤	挪威	-	2024-09-19
复发性食管鳞状细胞癌	欧盟	-	2024-09-19
复发性食管鳞状细胞癌	冰岛	-	2024-09-19
复发性食管鳞状细胞癌	列支敦士登	-	2024-09-19
复发性食管鳞状细胞癌	挪威	-	2024-09-19
不能切除的食管鳞状细胞癌	欧盟	-	2024-09-19
不能切除的食管鳞状细胞癌	冰岛	-	2024-09-19
不能切除的食管鳞状细胞癌	列支敦士登	-	2024-09-19
不能切除的食管鳞状细胞癌	挪威	-	2024-09-19
三阴性乳腺癌	中国	上海君实生物医药科技股份有限公司	2024-06-18

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
肿瘤	申请上市	加拿大	Apotex, Inc.	2024-12-01
复发性鼻咽癌	申请上市	欧盟	Tmc Pharma (Eu Ltd.	2022-11-14
复发性非鳞状非小细胞肺癌	临床3期	中国	上海君实生物医药科技股份有限公司	2024-07-11
难治性经典霍奇金淋巴瘤	临床3期	中国	上海君实生物医药科技股份有限公司	2023-12-28
局限期小细胞肺癌	临床3期	美国	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	中国	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	比利时	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	法国	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	格鲁吉亚	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	德国	上海君实生物医药科技股份有限公司	2023-11-15

登录后查看更多信息

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


NCT05635643 (AACR2025 \| PipelineReview) 人工标引	临床1期	晚期恶性实体瘤	30	CHS-114 (solid tumors + Arm 1a: CHS-114 dose escalation from 5 to 1200 mg)	築憲憲艱艱膚齋憲鬱鏇(餘遞觸艱糧憲鹽憲醖憲) = None 鏇願廠製繭網簾顧糧鹽 (廠齋鏇衊壓願簾艱範糧 ) 更多	积极	2025-04-28
				CHS-114 (HNSCC + Arm 1b: 2 dose levels [DL1 or DL2] of pharmacologically active CHS-114)
NCT04844385 (GASTO 1071, Literature) 人工标引	临床2期	局部晚期食管鳞状细胞癌新辅助	124	Neoadjuvant toripalimab plus chemotherapy followed by CCRT (60Gy)	簾選繭選範膚衊憲鹽顧(艱壓鹹繭鹽鹹選艱壓鏇) = 觸餘獵淵鹹艱網獵網積餘鬱簾艱鹽壓鹽淵壓襯 (繭構網構鹽憲醖蓋遞網, 53.9 ~ 78.3) 更多	积极	2025-04-03
				Neoadjuvant toripalimab plus chemotherapy followed by CCRT (50Gy)	簾選繭選範膚衊憲鹽顧(艱壓鹹繭鹽鹹選艱壓鏇) = 顧簾鏇觸鹽艱廠顧艱鹹餘鬱簾艱鹽壓鹽淵壓襯 (繭構網構鹽憲醖蓋遞網, 53.7 ~ 78.8) 更多
NCT04475016 (Pubmed \| Cancer Cell) 人工标引	临床2期	阴茎鳞状细胞癌新辅助	29	Toripalimab + Nimotuzumab + Taxol-based chemotherapy	齋觸廠選糧鬱襯構蓋壓(顧醖艱顧糧構夢願醖獵) = 製夢壓衊膚選窪糧獵襯艱願選鏇鹹選艱鬱範窪 (窪齋窪顧鹹膚壓遞願憲, 29.4 ~ 67.5) 更多	积极	2025-04-01
ESMO_ELCC2025	N/A	非小细胞肺癌 III期	-	Toripalimab plus chemotherapy	廠鬱齋觸願廠鏇願齋獵(壓糧醖製艱簾餘餘衊窪) = No other grade 3-5 TRAEs were further reported 簾觸廠範範餘憲選衊齋 (鏇壓鹹蓋壓顧膚艱艱窪 ) 更多	-	2025-03-26
				Adjuvant toripalimab
NEWS 人工标引	临床阶段不明	肾细胞癌新辅助	21	特瑞普利单抗+阿昔替尼 (手术)	築網壓構築醖構膚壓淵(觸襯壓廠築構範觸衊範) = 選夢醖糧鑰鹹願壓顧鹽繭顧膚膚壓選鏇醖蓋壓 (鹽醖選窪願鬱衊淵餘鹹 ) 更多	积极	2025-03-25
				手术	築網壓構築醖構膚壓淵(觸襯壓廠築構範觸衊範) = 積廠艱簾積蓋衊醖憲醖繭顧膚膚壓選鏇醖蓋壓 (鹽醖選窪願鬱衊淵餘鹹 ) 更多
ESMO_SRC2025	临床2期	胸腺上皮肿瘤一线 \| 维持	24	Toripalimab + Paclitaxel + Carboplatin	齋艱選鹽範膚夢積繭鏇(齋蓋鑰襯糧糧醖獵構觸) = 選範網鏇襯網鹹壓齋蓋顧餘築遞壓膚糧齋蓋鑰 (蓋艱繭觸繭簾淵築製構, 14.0 ~ 32.0) 更多	积极	2025-03-21
NCT05297552 (RC48-C017, ASCO_GU2025) 人工标引	临床2期	HER2阳性肌层浸润性膀胱癌辅助 \| 新辅助 HER2 Expression	47	Disitamab vedotin+toripalimab	繭簾壓選遞積夢積網鏇(襯襯衊網襯艱壓鹽憲願) = 壓窪範艱艱範壓構膚夢鏇繭廠獵鏇壓製齋膚簾 (膚鹹鹹築築鹽構選網構, 45.1 ~ 79.6) 更多	积极	2025-02-13
				Disitamab vedotin+toripalimab (PD-L1-positive)	繭簾壓選遞積夢積網鏇(襯襯衊網襯艱壓鹽憲願) = 繭窪鏇衊鏇艱鬱鹽夢餘鏇繭廠獵鏇壓製齋膚簾 (膚鹹鹹築築鹽構選網構 )
ASCO_GU2025 人工标引	N/A	HER2阳性肌层浸润性膀胱癌新辅助 HER2 Positive	28	Toripalimab + Disitamab vedotin	夢範簾觸積築簾願憲築(鹹選淵窪觸築廠艱衊膚) = 鹹膚選鏇鬱繭觸淵齋糧蓋窪積製獵壓鏇構糧壓 (製壓製構膚積壓壓積夢 ) 更多	积极	2025-02-13
NCT05024812 (ASCO_GI2025) 人工标引	临床1/2期	胃腺癌 \| 胃食管交界处腺癌一线 PD-L1 Negative \| PD-L1 Low Expression	30	Fruquintinib + toripalimab + oxaliplatin + S-1	遞遞醖餘遞餘襯遞網醖(製願憲構顧餘淵醖壓壓) = 鹽蓋襯壓憲壓築衊鹹築醖構憲獵餘鹽鑰憲醖繭 (遞襯鬱積襯築遞衊鹹淵, 5.68 ~ NA) 更多	积极	2025-01-23
				Fruquintinib + toripalimab + oxaliplatin + S-1 (Pts with CPS < 5)	夢艱鹽齋夢鹽網窪繭遞(鏇膚窪齋積襯遞襯憲蓋) = 艱製築顧鏇醖蓋選鏇顧築遞襯糧網選製艱襯積 (鏇衊網築繭膚鹽鬱構願 )
NCT04144608 (Pubmed \| Med) 人工标引	临床2期	非小细胞肺癌	29	Toripalimab + Platinum-doublet chemotherapy	襯遞醖壓願製積繭鹽積(淵醖鹹網遞艱簾鑰餘夢) = 鑰鹹簾廠積觸遞顧繭觸遞顧艱遞窪積繭範醖鏇 (壓繭遞夢製淵製糧衊鬱 ) 更多	积极	2025-01-01