Background:
A type of drug called monoclonal antibody immune checkpoint inhibitors are often used in cancer treatment. These drugs help the body s immune system fight cancer by blocking proteins that cause cancer cells to grow. One of these drugs (atezolizumab) is approved to treat certain cancers. Researchers want to find out if lower doses of this drug might provide the same benefit with fewer adverse effects.
Objective:
To test different doses and timing of atezolizumab for people with cancer.
Eligibility:
People aged 18 years and older with cancer that has spread locally or to other organs. They must be eligible for treatment with the study drug.
Design:
Participants will be screened. They will have blood tests and imaging scans. They will provide a sample of tissue from their tumor.
Atezolizumab is administered through a tube attached to a needle inserted into a vein in the arm. Participants will take this drug alone or combined with other drugs prescribed for their care.
The first 2 treatments will be done per the FDA recommended dose and schedule. Before administering the second dose of the study drug, researchers will check the level of the drug in the participant s blood. Depending on those results, their 3rd dose will be scheduled 2 to 6 weeks later.
For the 3rd dose of the study drug, participants will switch to the FDA minimum dosage. Dosages of any other drugs will not change.
Researchers will continue to test the levels of the drug in participants blood before each treatment for 16 weeks. After that, these levels will be tested every 3 months.
Study treatment may last up to 2 years.

开始日期2024-11-04

申办/合作机构

National Cancer Institute

NCT06600321 / Recruiting临床1期

A Phase 1 Study of ALN-BCAT as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma

The purpose of the dose escalation part of the study is to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as monotherapy and in combination with pembrolizumab. The purpose of the dose expansion part of the of the study is to evaluate the antitumor activity of ALN-BCAT as monotherapy and in combination with pembrolizumab; to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab.

开始日期2024-10-31

申办/合作机构

Alnylam Pharmaceuticals, Inc.

NCT06584071 / Not yet recruiting临床1/2期

A Phase Ib/II Clinical Trial to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of PM8002 Injection Combined With PM1009 Injection in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma

This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.

开始日期2024-10-01

申办/合作机构

普米斯生物技术（珠海）有限公司初创企业

100 项与转移性肝细胞癌相关的临床结果

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100 项与转移性肝细胞癌相关的转化医学

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0 项与转移性肝细胞癌相关的专利（医药）

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847

项与转移性肝细胞癌相关的文献（医药）

2024-11-01·Toxicon

Yangzheng mixture reversed EMT against hepatocellular carcinoma metastasis via NF-κB/NLRP3/β-catenin pathway

Article

作者: Dai, Bingling ; Hu, Yu ; Zhang, Yanmin ; Peng, Xiujuan ; Chen, Yanbin ; Nie, Yixuan ; Liu, Feng ; Gong, Zhengyan ; Li, Yuhong ; Wang, Xuemei

Yangzheng mixture has been used as an adjuvant tumor therapy as a traditional Chinese medicine in clinical. However, less is known about the activity of Yangzheng mixture. In our study, we explored the anti-tumor activity of Yangzheng mixture for HCC in vitro and in vivo. The effects of Yangzheng mixture on HCC biological behaviors were assessed using colony formation assay, EdU staining, cell cycle assay, Annexin V/PI staining, and wound healing assay. Migration and invasion of HCC cells were further evaluated via transwell assays, while molecular mechanisms were investigated through western blotting and immunofluorescence staining. Additionally, the anticancer effect of Yangzheng mixture in vivo were examined using H22 xenograft and H22 metastatic hepatocellular carcinoma models. Our results revealed that Yangzheng mixture inhibited colony formation, EdU incorporation, cell migration, and invasion, while arresting cell cycle at the G2-M phase in Bel-7402 and SMMC-7721 cells. Mechanistic studies demonstrated that Yangzheng mixture showed a markedly inhibition on Bel-7402 and SMMC-7721 cells with higher NLRP3 expression. We further confirmed that Yangzheng mixture could activate NLRP3 inflammasome through NF-κB by western blotting and immunofluorescence staining. Additionally, Yangzheng mixture inhibited β-catenin nucleus translocation and reversed EMT process. In vivo, the H22 xenograft model depicted that Yangzheng mixture significantly reduced tumor size and weight compared with control. Moreover, H22 lung metastasis model showed that Yangzheng mixture significantly inhibited liver cancer cell spreading to lungs in mice. Overall, our finding revealed that Yangzheng mixture inhibited HCC proliferation and migration in vitro and in vivo by reversing EMT via NF-κB/NLRP3/β-catenin pathway. These results may serve new therapeutic evidences for Yangzheng mixture application in clinical.

2024-10-01·Journal of Surgical Case Reports

Surgical resection of late extrahepatic metastasis of hepatocellular carcinoma 11 years after initial diagnosis: case report and literature review

Article

作者: Garg, Ravin ; Gibson, Glen ; Nudotor, Richard ; Ian, Bussey ; Baz, Carolina

AbstractHepatocellular carcinoma (HCC) is the second most common cause of cancer mortality worldwide. Liver resection is considered the pillar of curative treatment, although it is usually reserved for early-stage localized disease since the presence of metastases carries a poor prognosis. Despite advances in imaging, surgical techniques, and systemic therapy, the recurrence rate after oncologic resection remains high, even with localized disease. In the setting of extrahepatic HCC recurrence, there is no consensus regarding the best treatment strategy. Nevertheless, while the development of metastasis can be considered an expression of systemic disease, surgical resection may prolong survival. We report the case of a patient with a history of an oncologic hepatic resection for HCC, successfully treated with resection of an isolated peritoneal cavity metastasis. This case demonstrates that an aggressive approach involving the resection of extrahepatic HCC metastasis should be considered in select patients with the intention of achieving prolonged survival.

2024-09-03·Cureus

Complex Multi-site Stereotactic Body Re-irradiation With CT-Guided Online Adaptive Radiotherapy

Article

作者: Zhao, Xiaodong ; D'Souza, Alden ; Mazur, Tom ; Prusator, Michael T ; Kim, Hyun ; Hobbis, Dean ; Sievert, Domenic

Online adaptive radiotherapy optimizes a patient's treatment plan to their daily anatomy to account for inter-fraction motion. Daily target and organ-at-risk (OAR) delineation allows for optimized treatments and has been shown to have favorable outcomes in the abdominal region. Adaptive radiotherapy also has the potential to support fine control of dose in re-irradiation to OARs. Herein, we describe a complex multi-site re-irradiation case utilizing CT-guided adaptive radiotherapy. A 46-year-old man with metastatic hepatocellular carcinoma presented for re-irradiation of four metastatic lesions to the right acetabulum, T11, S2, and a gastrosplenic lymph node (gsLN). The right acetabulum, T11, and S2 lesions previously received 20 Gy in five fractions. For the current course, he was prescribed 35 Gy (T11, right acetabulum, and gsLN) and 30 Gy (S2) in five fractions. An equivalent dose in 2 Gy fractions (EQD₂) was employed to assess cumulative doses for critical OARs and guide planning. The re-irradiated lesions were treated with stereotactic body radiation therapy (SBRT), and the gsLN was treated with adaptive radiotherapy. An isotoxic approach was utilized to create the scheduled and adapted plans for the gsLN. Adapted plans were created on the patient's daily anatomy as visualized on kilovoltage cone beam computed tomography and compared against the scheduled plan. Dose-volume histogram objectives were used to compare the plans, and the superior plan was chosen for delivery. The adapted plan was used for all five fractions and met all critical OAR constraints while maintaining target coverage. The use of the scheduled plan would have resulted in stomach and/or esophagus constraint violations on all five fractions. This resulted in reduced EQD₂ doses of 6.4 and 12.3 Gy for the esophagus and stomach, respectively. We report the successful treatment of a patient undergoing tri-site SBRT re-irradiation with concurrent CT-guided adaptive radiotherapy to a gsLN. The adaptive treatment allowed us to meet critical OAR constraints while maintaining target coverage. Few studies have described the use of CT-guided adaptive radiotherapy in re-irradiation cases, and the potential benefit for these complex cases is evident.

246

项与转移性肝细胞癌相关的新闻（医药）

2024-10-30

·Pharma CMC

君实生物三季报：「特瑞普利单抗」国内收入超10亿元

10月29日晚，君实生物发布2024年第三季度报告，公司前三季度实现营收12.71亿元，同比增长28.87%；归母净利润亏损9.27亿元。其中，第三季度实现营收4.85亿元。据公告披露，营业收入增长主要来自商业化药品销售收入的增长，其中，核心产品拓益®（特瑞普利单抗）于国内市场实现销售收入人民币约10.68亿元，同比增长约60%。拓益®2024年第三季度于国内市场实现销售收入人民币约3.97亿元，同比增长约79%。报告期内，特瑞普利单抗联合贝伐珠单抗用于不可切除或转移性肝细胞癌患者的一线治疗的新适应症上市申请和特瑞普利单抗用于不可切除或转移性黑色素瘤的一线治疗的新适应症上市申请获得国家药监局受理；此外，特瑞普利单抗获得欧盟委员会（EC）批准用于治疗两项适应症：特瑞普利单抗联合顺铂和吉西他滨用于复发、不能手术或放疗的，或转移性鼻咽癌成人患者的一线治疗；特瑞普利单抗联合顺铂和紫杉醇用于不可切除的晚期/复发或转移性食管鳞癌成人患者的一线治疗。截至本报告披露日，特瑞普利单抗的10项适应症已于中国内地获批，并已在中国香港、美国、欧盟、印度等国家和地区获得批准上市。其他管线方面，报告期初至本报告披露日：昂戈瑞西单抗注射液（重组人源化抗PCSK9单克隆抗体注射液，商品名：君适达®）获得国家药监局批准上市，用于治疗原发性高胆固醇血症（非家族性）和混合型血脂异常成人患者；靶向组蛋白去乙酰化酶（HDACs）抑制剂WJ47156片（项目代号：JS125）的临床试验申请获得国家药监局批准。

财报上市批准

2024-10-30

·Insight数据库

君实生物：PD-1 单抗前三季度收入超 10 亿元，同比增长约 60%

10 月 29 日晚间，君实生物发布 2024 年第三季度报告。Q3 期间，公司营业收入 4.85 亿元，同比增长 53.16%；前三季度总营收 12.71 亿元，同比增长 28.87%。君实营业收入增长主要来自商业化药品销售收入的增长。其中，核心产品 PD-1 抑制剂拓益（特瑞普利单抗，JS001）第三季度国内销售收入约 3.97 亿元，同比增长约 79%。加上上半年的收入，拓益今年前三季度的国内销售额已达约 10.68 亿元，同比增长约 60%。截图来源：君实公告报告期内，特瑞普利单抗取得了一些重要的里程碑进展，包括：两项新适应症上市申请获得中国国家药监局（NMPA）受理，分别为联合贝伐珠单抗用于不可切除或转移性肝细胞癌患者的一线治疗，以及特瑞普利单抗用于不可切除或转移性黑色素瘤的一线治疗。获得欧盟委员会（EC）批准用于治疗两项适应症：特瑞普利单抗联合顺铂和吉西他滨用于复发、不能手术或放疗的，或转移性鼻咽癌成人患者的一线治疗，以及特瑞普利单抗联合顺铂和紫杉醇用于不可切除的晚期/复发或转移性食管鳞癌成人患者的一线治疗。截至目前，特瑞普利单抗的 10 项适应症已于中国内地获批，并已在中国香港、美国、欧盟、印度等国家和地区获得批准上市。报告期内其他管线进展还包括：昂戈瑞西单抗注射液（重组人源化抗 PCSK9 单克隆抗体注射液，商品名：君适达）获得 NMPA 批准上市，用于治疗原发性高胆固醇血症（非家族性）和混合型血脂异常成人患者；靶向组蛋白去乙酰化酶（HDACs）抑制剂 WJ47156 片（JS125）的临床试验申请获得 NMPA 批准。君实在公告中表示，未来将加快推进抗肿瘤抗 BTLA 单抗 Tifcemalimab（TAB004/JS004）、抗 IL-17A 单抗（JS005）等后期阶段管线的研发和上市申请等工作，并持续探索包括 Claudin18.2 ADC 药物（JS107）、PI3K-α 口服小分子抑制剂（JS105）、CD20/CD3 双特异性抗体（JS203）、PD-1/VEGF 双特异性抗体（JS207）、抗 DKK1 单克隆抗体（JS015）等产品在内的早期阶段管线，尽快推动更多优势产品和适应症进入注册临床试验阶段。封面来源：企业 Logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：馨药 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

抗体药物偶联物财报上市批准

2024-10-25

·米内网

【市场】创新国际化战略双轮驱动，恒瑞医药三季报营收、净利润双增

精彩内容 10月24日晚，恒瑞医药公布2024年三季度业绩报告，公司业绩稳健增长：前三季度恒瑞医药实现营业收入201.89亿元，同比增18.67%，归属于上市公司股东的净利润46.20亿元，同比增32.98%，归属于上市公司股东的扣除非经常性损益的净利润46.16亿元，同比增37.38%，展现稳健发展势头。恒瑞医药持续深入践行科技创新和国际化发展战略，大幅度加码创新研发。报告显示，2024年前三季度研发费用达45.49亿元，同比大增22%。持续高强度研发投入，为公司创新成果转化提供强大动力。随着持续高强度投入研发，恒瑞医药创新成果也不断涌现。公司自身免疫疾病领域首个创新药夫那奇珠单抗注射液获批上市，这是公司慢病创新的又一里程碑，至此公司在国内获批上市1类创新药增至17款。今年以来公司共有7项创新药上市许可申请获得国家药监局受理，共取得6项突破性疗法认定，其中第三季度分别为3项和1项，同时在研管线储备充足，未来值得期待。申银万国分析认为，恒瑞医药始终将创新和国际化作为自身的战略发展目标，持续坚持高比例研发投入，创新药成为公司业绩增长主要驱动力，同时BD授权交易为公司贡献了新的利润增长点。公司创新升级，全球化加速。创新成果加速涌现，上市申报进展显著在高强度研发投入加持下，恒瑞医药创新成果不断涌现，报告期内公司自主研发的1类新药夫那奇珠单抗注射液上市，用于治疗适合接受系统治疗或光疗的中重度斑块状银屑病成人患者，该产品是恒瑞在自身免疫疾病领域上市的首个创新药，至此，恒瑞医药已在国内获批上市17款1类创新药、4款2类新药。夫那奇珠单抗自上市以来已覆盖全国30个省份，惠及更多银屑病患者。上市申报方面成果显著，第三季度共有3项创新药上市许可申请获得国家药监局受理，分别为抗PD-L1/TGF-βRII双功能融合蛋白瑞拉芙普α注射液（SHR-1701）用于局部晚期不可切除、复发或转移性胃及胃食管结合部腺癌的一线治疗；HER2 ADC创新药注射用瑞康曲妥珠单抗（SHR-A1811）用于既往接受过至少一种系统治疗的局部晚期或转移性HER2突变成人非小细胞肺癌患者的治疗，该产品同时已被纳入优先审评审批，以及JAK1抑制剂硫酸艾玛昔替尼片用于成人重度斑秃患者，该产品已有4项适应症上市许可申请获得受理。此外，另有2项创新药上市许可申请于今年10月获得受理：口服非肽类血小板生成素受体激动剂海曲泊帕乙醇胺片联合免疫抑制治疗用于15岁及以上初治重型再生障碍性贫血（SAA）患者；EZH2抑制剂SHR2554片用于既往接受过至少1线系统性治疗的复发或难治外周T细胞淋巴瘤（PTCL），该产品同时已被纳入优先审评审批。同时公司在研管线储备充足，有90多个自主创新产品正在临床开发，300余项临床试验在国内外开展。报告期内公司共有22个药物获得临床试验批件，第三季度公司自主研发的血管生成素样蛋白3（ANGPTL3）单克隆抗体SHR-1918注射液用于治疗纯合子家族性高胆固醇血症被国家药品监督管理局药品审评中心纳入突破性治疗品种，另外HR19042胶囊自身免疫性肝炎适应症于今年10月被纳入突破性治疗品种，未来审批有望加速。国际化稳步推进，2款首仿产品海外获批上市恒瑞医药稳步推进国际化战略，今年下半年以来公司布比卡因脂质体注射液、注射用紫杉醇（白蛋白结合型）获准在美国上市，前者是该品种全球范围内获批上市的首仿药，有较高的技术壁垒，后者为美国FDA批准上市的该品种首仿药。此外，在报告期内，公司盐酸右美托咪定注射液、原料药盐酸右美托咪定均获得日本药品医疗器械局（PMDA）颁发的GMP认证证书，体现了国际权威机构对公司质量管理体系的认可。公司坚持自主研发与开放合作并重，在内生发展的基础上加强国际合作。公司稳步推进创新药海外临床，并在近期重新向美国FDA提交了卡瑞利珠单抗（艾瑞卡®）联合甲磺酸阿帕替尼（艾坦®）（“双艾”组合）用于不可切除或转移性肝细胞癌患者一线治疗的生物制品许可申请（BLA），并得到正式受理；目前公司共有SHR-A2009、SHR-A1912、SHR-A1921、SHR-A2102四款ADC创新药获得美国FDA快速通道资格认定。在开放合作方面，通过与美国、韩国、印度公司合作，恒瑞医药已将11款具有自主知识产权的创新药对外授权，造福更多全球患者。今年5月，公司将具有自主知识产权的GLP-1类创新药产品组合许可给一家美国公司，首付款加里程碑付款累计可高达60亿美元，并取得该公司19.9%的股权。研发实力备受国际学术界肯定恒瑞创新研发实力持续得到国际学界肯定。在9月7日至10日举办的2024年世界肺癌大会（WCLC）、9月13日至17日举办的2024年欧洲肿瘤内科学会（ESMO）年会上，恒瑞医药凭借肿瘤治疗领域的深入布局和研发创新实力，相继公布了近50项创新药研究成果，共涉及近20款多靶点上市产品及在研产品，包含近10项口头报告（Oral），覆盖食管胃癌、妇科肿瘤、肝癌、乳腺癌、胰腺癌、肺癌、黑色素瘤、胆道癌、头颈鳞癌、前列腺癌、甲状腺癌等十余个疾病领域。此外，多项慢病创新成果亮相欧洲糖尿病研究协会年会（EASD）、欧洲心脏病学会（ESC）年会和欧洲皮肤病与性病学会（EADV）大会等知名学术会议，共涉及HRS9531、SHR-1918、夫那奇珠单抗等创新产品，涵盖代谢、心血管、自免等疾病领域，展现了公司在慢病创新领域的进步与突破。其中，GLP-1/GIP双受体激动剂HRS9531在2型糖尿病（T2DM）患者中的有效性和安全性的Ⅱ期临床研究数据亮相欧洲糖尿病研究协会年会（EASD），结果显示[1]，HRS9531可提高血糖达标率，降低体重，耐受性良好，为其将来在2型糖尿病人群中进一步研发奠定了坚实基础。积极践行社会责任，MSCI ESG评级连续获评A级作为中国医药创新代表性企业，恒瑞医药始终秉持“企业公民”的社会责任，力求发展成果惠及民生、回馈社会。今年7月，恒瑞提供公益支持的2024年度“爱卫新征程健康中国行”公益项目启动，该活动天津站已成功举办。此外，恒瑞公益支持的“体重管理年”活动也已正式启动。公司坚持贯彻可持续发展理念，在环境、社会与管治层面持续提升完善，实现公司高质量全面发展。近日，国际权威指数机构摩根士丹利资本国际公司（简称“MSCI”）公布2024年环境、社会及管治（英文简称“ESG”）评级结果，恒瑞医药连续两年获评“A”级，在中国医药行业处于领先水平。此外，近日上海证券交易所公布了沪市上市公司2023-2024年度信息披露工作评价结果，凭借在信息披露、规范运作以及投资者关系管理等方面的优秀表现，恒瑞医药再次获评A级。凭借创新、国际化双轮驱动取得的突出成果，公司第三季度在国内外多个权威评选中屡获佳绩。入选《财富》杂志首次推出的“2024年《财富》中国科技50强”榜单；连续多年入选“中国医药工业百强榜”榜单，连续第12年登上“中国医药研发产品线最佳工业企业”榜首。参考文献：1. Zhao J, et al.LBA 66Efficacy and safety of HRS9531, a novel dual GLP-1/GIP receptor agonist, in patients with type 2 diabetes mellitus (T2DM): a phase 2 trial. Presented at EASD annual meeting. 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

财报优先审批上市批准抗体药物偶联物突破性疗法