Advanced cervical cancer patients treated with standard of care (SOC) chemoradiation plus glutaminase inhibition with telaglenastat (CB-839) will have increased progression-free survival (PFS) compared to historical rates for patients receiving SOC chemoradiation alone.

开始日期2025-01-31

申办/合作机构

Washington University School of Medicine

[+2]

NCT06315257

/ Not yet recruiting临床1期IIT

A Randomized, Open-label Clinical Trial to Assess the Safety, Feasibility and Immunogenicity of Adjuvant PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients

A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy.

开始日期2025-01-01

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+1]

NCT06626256

/ Not yet recruiting临床1期IIT

A Phase 1 Safety and Efficacy Study of STIL101 for Injection in Locally Advanced, Unresectable, or Metastatic Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Renal Cell Carcinoma, Cervical Cancer, and Melanoma

This phase I trial tests the safety and side effects of STIL101 for injection and how well it works in treating patients with pancreatic cancer, colorectal cancer (CRC), renal cell cancer (RCC), cervical cancer (CC) and melanoma that has spread to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). STIL101 for injection, an autologous (made from the patients own cells) cellular therapy, is made up of specialized white blood cells called lymphocytes or "T cells" collected from a piece of the patients tumor tissue. The T cells collected from the tumor are then grown in a laboratory to create STIL101 for injection. STIL101 for injection is then given to the patient where it may attack the tumor. Giving chemotherapy, such as cyclophosphamide and fludarabine, helps prepare the body to receive STIL101 for injection in a way that allows the T cells the best opportunity to attack the tumor. Aldesleukin is a form of interleukin-2, a cytokine made by leukocytes. Aldesleukin increases the activity and growth of white blood cells called T lymphocytes and B lymphocytes. Giving STIL101 for injection may be safe, tolerable and/or effective in treating patients with locally advanced, metastatic or unresectable pancreatic cancer, CRC, RCC, CC and melanoma.

开始日期2024-12-30

申办/合作机构

City of Hope National Medical Center

[+1]

100 项与转移性宫颈癌相关的临床结果

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100 项与转移性宫颈癌相关的转化医学

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0 项与转移性宫颈癌相关的专利（医药）

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2,778

项与转移性宫颈癌相关的文献（医药）

2025-06-01·Tumour Virus Research

Drugs and drug targets for the treatment of HPV-positive cervical cancer

Review

作者: Prince, Sharon ; Khan, Saif F ; Burmeister, Carly A

Cervical cancer is primarily driven by persistent infection with high-risk human papillomavirus (HPV) strains and remains a significant global health challenge, particularly in low- and middle-income countries where late-stage diagnoses is common. While vaccination and screening programs have reduced incidence rates, the need for novel and more effacacious and cost-effective therapeutic options is therefore critical especially for advanced cervical cancer. This review highlights several key advances in the understanding of HPV-induced carcinogenesis and the development of therapeutic strategies over the past five years. Important areas of focus include the role of HPV oncoproteins E5, E6 and E7 in modulating signalling pathways, treatment strategies for precancerous lesions, the potential of natural compounds to target cervical cancer cells, and the emergence of immunotherapies, checkpoint inhibitors, antibody-drug conjugates, and novel drug combinations to treat cervical cancer. Additionally, lifestyle recommendations and the integration of natural supplements are discussed for their potential to enhance treatment efficacy and improve patient outcomes. The developments reported in this review underscore the evolving landscape of cervical cancer treatment and the need for continued research to validate and integrate these emerging therapies into clinical practice.

2025-02-01·Gynecologic Oncology Reports

Views on cervical cancer screening among female caregivers at the Uganda cancer Institute

Article

作者: Kisakye, Sheila Irene ; Ghebre, Rahel ; Teoh, Deanna ; Origa, Martin ; Bollinger, Lauren ; Kayiira, Anthony

Patients admitted to Uganda Cancer Institute (UCI) have their non-medical needs provided by caregivers called "attendants" who are predominantly female family members. This provides a unique opportunity to provide free screening among attendants during their free time at the hospital. The objective of this qualitative focus group study was to understand knowledge of and facilitators and barriers to cervical cancer screening among attendants at the UCI. The goal is to use these data to inform a future opportunistic intervention. Female attendants 25 years of age or older were included in this focus group study. The focus group discussions explored knowledge of cervical cancer and screening modalities, health information sources, barriers and facilitators for cervical cancer screening, and potential use of mobile phone technology to share cervical cancer screening information among one's social community. Data were analyzed using an inductive approach and thematic analysis. Results showed moderate understanding of risk factors for cervical cancer, supplemented by misinformation. Knowledge of symptoms of advanced cervical cancer was high. Most participants were aware that cervical cancer screening exists but knew little about screening modalities. Responses were mixed regarding preferred information sources, and included healthcare workers and facilities, radio and family members. Participants were enthusiastic about mobile phone messaging to provide information about screening but emphasized a need to catch their attention and incentivize screening with promise of good such as sugar, demonstrating prioritization of immediate needs over future cancer risk. These results will inform an intervention which aims to connect female caregivers with free screening available at the adjacent cancer prevention clinic.

2025-02-01·Journal of Gynecology Obstetrics and Human Reproduction

Neoadjuvant chemotherapy with carboplatin and paclitaxel in pregnant women with advanced stage cervical cancer: Maternal and perinatal outcomes

Article

作者: Araujo Júnior, Edward ; Bonetti, Tatiana Carvalho de Souza ; Almeida, Michelle Samora ; Ferraz, Bruna Elias Parreira Lopes ; Braga, Antonio ; Signorini Filho, Roney César ; Carvalho, Lucas Ribeiro Borges ; Sun, Sue Yazaki

OBJECTIVECervical cancer is the third most common cancer in Brazil. Although rare, its diagnosis during pregnancy represents a great challenge for the medical team and the patient. The objective of this study was to evaluate the maternal and perinatal outcomes of pregnant women who underwent neoadjuvant chemotherapy with carboplatin and paclitaxel for advanced stage cervical cancer.METHODSThis was a descriptive, retrospective study that included pregnant women with advanced stage cervical cancer (IB3 a IIIC1) who were treated at our center over 12 years. These patients received neoadjuvant chemotherapy with carboplatin plus paclitaxel during pregnancy to prevent disease progression.RESULTSTumor shrinkage of at least 50 % was observed in four patients, while the disease remained stable in three others. There was one case of fetal death without apparent cause at 29 weeks, but all other mothers were discharged from the hospital at the same time as their healthy newborns.CONCLUSIONChemotherapy with carboplatin and paclitaxel administered to pregnant women with advanced stage cervical cancer (IB3 - IIIC1) may have prevented disease progression without worsening neonatal outcomes.

609

项与转移性宫颈癌相关的新闻（医药）

2025-01-20

·齐鲁制药集团

伊鲁阿克之后，齐鲁制药重磅1类抗癌新药齐倍安又写入山东省政府工作报告里了！

1月20日，山东省十四届人大三次会议开幕，“1类靶向抗癌新药‘齐倍安’获批上市”写入2025年山东省政府工作报告。这也是继伊鲁阿克片后，齐鲁制药重磅研发成果再次写入省政府工作报告。齐鲁制药齐倍安®（艾帕洛利托沃瑞利单抗注射液，简称“艾托组合抗体”）是全球首个获批上市的PD-1/CTLA-4双功能组合抗体，于2024年9月获得国家药品监督管理局上市批准，用于治疗复发或转移性宫颈癌。产品历时7年自主研发，获批上市比预计时间提前了两年，更快地惠及众多患者。上周，“1类新药艾帕洛利托沃瑞利单抗注射液”刚刚入选2024年度山东省十大科技创新成果。免疫治疗是继手术、放疗、化疗、靶向治疗之后，又一种肿瘤治疗选择。PD-1抗体联合CTLA-4抗体的双免疫治疗已批准用于多种晚期实体瘤的治疗，然而，双免疫治疗产生的毒性明显增加，亟需开发高效低毒的双免疫治疗手段以满足临床需求。齐鲁制药积极布局，2015年成功开发创新的组合抗体MabPair技术平台，艾托组合抗体就是MabPair平台孕育的成果。艾托组合抗体中的CTLA-4抗体成分经过了科学设计和改造，得到可以平衡治疗效果和副反应的适当半衰期，配以组合抗体平台对各组分比例控制的独特优势，艾托组合抗体可以在体内维持达到最佳治疗效果所需的PD-1抗体暴露量和CTLA-4抗体的暴露量，毒性更低、耐受性更佳。同时，与常规双特异性抗体平台相比，MabPair组合抗体平台开发的药物在结构上更接近天然抗体，成药性高，稳定性好；与传统的抗体联合治疗相比，有助于提升临床疗效和给药便利性。除宫颈癌外，齐倍安®还在非小细胞肺癌、小细胞肺癌、肝癌、食管癌等多个瘤种中开展了临床研究，力争为重大疾病治疗提供更多新的选择。 2024年1月，在山东省十四届人大二次会议上，“1类靶向创新药伊鲁阿克片获批上市”写入2024年山东省政府工作报告。齐鲁制药十年磨一剑，2013年6月立项研发，2023年6月，伊鲁阿克片（启欣可®）获得国家药监局上市批准，适用于既往接受过克唑替尼治疗后疾病进展或对克唑替尼不耐受的间变性淋巴瘤激酶（ALK）阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者的治疗。2024年1月，获批ALK阳性NSCLC晚期一线治疗新适应症后，伊鲁阿克片实现覆盖全部ALK阳性局部晚期或转移性非小细胞肺癌患者人群，并且新适应症已纳入国家医保目录。非小细胞肺癌是肺癌中最常见的病理组织学类型，约占肺癌的85％，其早期诊断难，患者预后差，往往一经确诊就已经处于晚期，是肺癌患者致死率高的主要原因。间变性淋巴瘤激酶作为晚期NSCLC的重要治疗靶点之一，因其靶向药物有良好的治疗效果，因而该靶点被冠以“钻石突变”的称号。对于经中心试验室复测为ALK阳性晚期NSCLC患者，这款1类新药一线治疗的中位PFS达到45.9个月；在针对中国人群的晚期一线同类已上市产品的临床研究中，伊鲁阿克研究纳入患者人数最多；伊鲁阿克I-III期的研究数据全部来自中国人群，更贴近中国的临床诊疗环境，便于其在中国患者中的临床应用。以患者为中心，以临床价值为导向，齐鲁制药始终紧跟国际医药前沿，聚焦多个未被满足的重大疾病领域，致力于做有温度的科技创新。目前，齐鲁制药已在肿瘤、感染、自身免疫、代谢疾病等重大疾病领域构建了完善的创新药物管线，持续开发“全球新”“全球好”药物。齐鲁制药将继续秉持“大医精诚，家国天下”的核心价值观，快速推动更多创新药物的上市，造福更多患者！点击下方关键词获取更多资讯 ↓↓ | 李燕总裁 | 全国人大代表 | | 中国医药百强 | 伊鲁阿克 | | 雷珠单抗 | 全球首创艾托组合抗体 | 患者招募 | | 董事长的二十万个蛋糕 | 社会责任企业 |

上市批准免疫疗法临床结果上市后研究

2025-01-17

·药明康德

癌症患者复发风险降低近70%！重磅免疫疗法达3期临床主要终点

再生元公司（Regeneron Pharmaceuticals）日前宣布了3期临床试验C-POST的积极结果。试验结果显示，PD-1抑制剂Libtayo（cemiplimab，西米普利单抗）作为辅助治疗，在接受手术后的高风险皮肤鳞状细胞癌（CSCC）患者中，在主要终点无病生存期（DFS）方面提供了统计学上显著且具有临床意义的改善。新闻稿指出，Libtayo是首个在辅助治疗中对高风险CSCC患者显示统计学显著且具有临床意义获益的免疫疗法。 C-POST试验共纳入415名高风险CSCC患者，这些患者被随机分配接受Libtayo或安慰剂治疗，治疗时间最长为48周。主要终点为DFS，定义为从随机化到首次记录的疾病复发或因任何原因死亡的时间。在中位随访时间为24个月的首次预设中期分析中，Libtayo与安慰剂相比，将患者疾病复发或死亡的风险降低了68%（HR：0.32；95% CI：0.20-0.51；p<0.0001）。在安全性评估中，Libtayo组和安慰剂组中分别有91%和89%的患者出现了任意级别的不良事件（AEs）。3级及以上AEs发生率在Libtayo组和安慰剂组中分别为24%和14%。因不良反应导致的治疗中断在Libtayo组和安慰剂组中分别为10%和1.5%。每组均有两名患者因AEs导致死亡。根据这些中期结果，C-POST试验将继续进行额外的随访，包括对关键次要终点——总生存期的分析。详细结果将在即将召开的医学会议上公布，并将与监管机构分享。再生元计划于2025年上半年向美国FDA提交监管申请。 Libtayo是一种完全人源化的单克隆抗体，靶向T细胞上的免疫检查点受体PD-1。通过结合PD-1，Libtayo能够阻止癌细胞利用PD-1信号通路抑制T细胞活性。Libtayo已在包括晚期基底细胞癌（BCC）、晚期CSCC、晚期非小细胞肺癌（NSCLC）和晚期宫颈癌等多个适应症中，获得了超过30个国家和地区的监管批准。参考资料： [1] Adjuvant Libtayo® (cemiplimab) Significantly Improves Disease-Free Survival (DFS) After Surgery in High-Risk Cutaneous Squamous Cell Carcinoma (CSCC) in Phase 3 Trial. Retrieved January 14, 2025, from https://investor.regeneron.com/news-releases/news-release-details/adjuvant-libtayor-cemiplimab-significantly-improves-disease-free 内容来源于网络，如有侵权，请联系删除。

免疫疗法临床结果

2025-01-16

·SYNAPSE

2025年1月16日全球新药进展早知道

1. 勃林格殷格翰口服HER2抑制剂在中国申报上市 1月15日，CDE官网显示，勃林格殷格翰（BI）的口服HER2抑制剂宗格替尼片(BI 1810631，Zongertinib)的上市申请已获受理，用于治疗携带HER2（ERBB2）激活突变且既往接受过系统治疗的不可切除或转移性非小细胞肺癌（NSCLC）成人患者。此前，该药物已获得CDE的突破性治疗认定和优先审评。2024年4月，BI与中国生物制药签署了战略合作协议。双方将依托各自优势和资源，共同在中国内地研发和商业化BI的肿瘤药物管线，其中就包括了宗格替尼。 2. 新型抗菌药在中国申报上市，赛生药业共同开发 1月15日，CDE官网公示，美纳里尼和赛生药业共同递交了5.1类新药注射用美罗培南韦博巴坦的上市申请，并获得受理。公开资料显示，这是一款抗生素复方制剂（商品名：Vaborem），为新型抗菌药物。赛升药业在2022年8月与美纳里尼亚太公司达成许可及合作协议，从而可在中国境内独家开发和商业化该产品。2024年2月，赛生药业宣布Vaborem在中国开展的3期临床研究已完成全部受试者入组，该项研究数据将用于支持Vaborem在中国提交上市申请，针对的适应症为复杂性尿路感染（包括急性肾盂肾炎）。 3. 济民可信KRAS G12C抑制剂拟纳入优先审评 1月15日，CDE官网显示，济民可信子公司杭煜制药申报的JMKX001899片拟纳入优先审评，适用于至少接受过一种系统性治疗的鼠类肉瘤病毒癌基因（KRAS）G12C突变型的晚期非小细胞肺癌（NSCLC）成人患者。JMKX001899是济民可信旗下上海济煜小分子创新中心自主研发的KRAS抑制剂。临床前研究数据显示，与同靶点产品相比，JMKX001899具有较强的脑通透性，且没有心脏毒性和药物-药物相互作用风险。2021年11月，大中华区以外的全球权益授权给沪亚。 4. 乐普生物溶瘤病毒CG0070拟纳入突破治疗药物 1月14日，乐普生物创新溶瘤病毒疗法CG0070拟纳入突破治疗药物程序，用于治疗卡介苗（BCG）无应答的高危非肌层浸润性膀胱癌（NMIBC）伴原位癌（CIS）患者。CG0070由CG Oncology研发，为一款工程化5型腺病毒溶瘤病毒，嵌入了两种编码基因-肿瘤选择性启动子E2F-1和GM-CSF基因。此前已经获得FDA的突破性疗法认证和快速通道资格。2019年3月，乐普生物引进CG0070的大中华区权益。乐普生物同时手握已上市的PD-1抗体普特利单抗可以形成互补，联合治疗NMIBC进一步提升疗效。 5. 再鼎医药「维替索妥尤单抗」宫颈癌全球3期研究中国亚组取得阳性主要结果 1月15日，再鼎医药宣布，全球3期innovaTV 301研究中国亚组的主要结果显示，与化疗相比，TF ADC维替索妥尤单抗（tisotumab vedotin）对于在之前接受过治疗的复发或转移性宫颈癌患者中，显示出具有临床意义的总生存期改善。中国亚组数据和全球人群数据保持一致：与化疗相比，维替索妥尤单抗降低死亡风险率45%（危险比：0.55 [95% CI: 0.27-1.15]），中位OS尚未达到，而化疗组为10.7个月 [95% CI: 6.0-尚未达到]，中位随访时间为11.5个月。相比化疗，次要终点无进展生存期（PFS）和确认的客观缓解率（ORR）也有利于维替索妥尤单抗的治疗。维替索妥尤单抗在中国亚组的安全性可控，且与全球一致。 6. NextCure启动B7-H4 ADC临床试验 1月14日，NextCure在clinical trials网站上登记公示了B7-H4 ADC药物LNCB74的一项1期临床试验，针对多种实体瘤（登记号：NCT06774963）。该临床预计于2025年1月底启动，入组人数为145例。NextCure此前基于陈列平教授的背书，开发Siglec-15单抗而名声大燥，但随着Siglec-15单抗的开发失败，公司走向衰败，多个管线终止以及人员精简。NextCure放弃了B7-H4单抗，转向和LegoChem Biosciences合作开发B7-H4 ADC药物LNCB74，成为其临床中唯一的管线，也是最后一搏。 7. 恒瑞皮下注射EGFR/c-Met双抗在中国获批开展临床试验 1月15日，恒瑞医药宣布，公司收到国家药品监督管理局（以下简称 “国家药监局”）核准签发关于注射用SHR-9839(sc)的《药物临床试验批准通知书》，将于近期开展临床试验。SHR-9839是一款靶向EGFR/c-Met双特异性抗体，拟用于治疗晚期恶性肿瘤。此前，该产品的注射制剂已获批开展临床试验，目前处于I/II期阶段。截至目前，SHR-9839 相关项目累计已投入研发费用约为 5,745 万元。 1. 体内CAR-T细胞疗法火爆！Umoja Biopharma完成1亿美元C轮融资 1月14日，体内CAR-T细胞疗法领导者Umoja Biopharma宣布完成1亿美元C轮融资。本轮融资由Double Point Ventures和DCVC Bio共同领投，ARK Invest、Cormorant Asset Management、 MPM Capital、 Qiming Venture Partners USA等新老投资者参投。融资收益将用于推进Umoja体内CAR-T细胞疗法管线，包括其领先的靶向CD22的UB-VV400项目在多种肿瘤和自身免疫性疾病中的临床研究。内容来源于网络，如有侵权，请联系删除。