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2025-04-30

申办/合作机构

City of Hope National Medical Center

[+1]

NCT06916117

/ Not yet recruiting临床2期IIT

A Prospective Single Arm Trial of Neoadjuvant Chemo-immunotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy in Locally Advanced Cervical Cancer

Concurrent chemoradiotherapy -immunotherapy followed by ICI maintenance was proved to improve the PFS by the Keynote-A18 in the LACC patients, and still more than 30% progressed. Neoadjuvant chemo-immunotherapy in LACC resulted in higher pCR rate. This prospective single arm study is to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy in LACC patients.

开始日期2025-04-05

申办/合作机构-

NCT05570422

/ Not yet recruiting临床1期

A Phase 1/2 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01 Intratumoral Injection Combined With Radiotherapy in Patients With Locally Advanced Cervical Cancer

This is a seamless Phase 1/2 study consisting of two components. Phase 1 component is a dose-escalation, single arm, open label study in 10 patients to evaluate the safety and tolerability of KRC 01. Phase 2 component is a randomized, open label, controlled, multi-center study in 60 patients to evaluate the preliminary antitumor effect of KRC-01 in combination with CRT.

开始日期2025-04-01

申办/合作机构

KORTUC, Inc.

100 项与局部晚期宫颈癌相关的临床结果

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100 项与局部晚期宫颈癌相关的转化医学

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0 项与局部晚期宫颈癌相关的专利（医药）

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2,712

项与局部晚期宫颈癌相关的文献（医药）

2025-12-31·International Journal of Hyperthermia

Addition of PARP1-inhibition enhances chemoradiotherapy and thermoradiotherapy when treating cervical cancer in an in vivo mouse model

Article

作者: Oei, Arlene L. ; Crezee, Johannes ; Stalpers, Lukas J. A. ; Scutigliani, Enzo M. ; Franken, Nicolaas A. P. ; Mei, Xionge ; Krawczyk, Przemek M. ; Rodermond, Hans M. ; IJff, Marloes ; van Bochove, Gregor G. W.

Background: Efficacy of current treatment options for cervical cancer require improvement. Previous in vitro studies have shown the enhancing effects of the addition of PARP1-inhibitors to chemoradiotherapy and thermoradiotherapy. The aim of our present study was to test efficacy of different combinations of treatment modalities radiotherapy, cisplatin, hyperthermia and PARP1-inhibitors using in vitro tumor models, ex vivo treated patient samples and in vivo tumor models.Materials and Methods: In vitro clonogenic survival curves (0-6 Gy) show that PARP1-i (4-5 M Olaparib) enhances both chemoradiotherapy (0.3-0.5 µM cisplatin) and thermoradiotherapy (42 °C for 1 h) in SiHa, CaSki and HeLa cells. A cervical cancer mouse model and freshly obtained in-house developed patient-derived organoids were used to examine the effects of different treatment combinations. For the in vivo study, human cervical cancer (SiHa) cells were injected in the right hind leg of athymic nude mice. In vivo mouse experiments show that PARP1-i enhances thermoradiotherapy or chemoradiotherapy by reduction of tumor volumes. Five cycles of treatment were applied with the following doses per cycle: irradiation 3 Gy, hyperthermia 1 h at 42 °C, cisplatin at 2 mg/kg, and twice PARP1-i at 50 mg/kg.Results: Quadruple treatment, combining radiotherapy, hyperthermia, cisplatin and PARP1-i, was very effective but also lead to severe side effects causing severe weight loss and death. In contrast, thermoradiotherapy or chemoradiotherapy with addition of PARP1-i, were effective without serious side effects.Conclusion: The triple combinations are promising options for potentially more effective treatment of locally advanced cervical cancer without more toxicity.

2025-12-01·Cancer Chemotherapy and Pharmacology

Dose finding, bioavailability, and PK-PD of oral triapine with concurrent chemoradiation for locally advanced cervical cancer and vaginal cancer (ETCTN 9892)

Article

作者: Richardson, Debra L ; Mahdi, Haider ; Kunos, Charles ; Behr, Sarah ; Cooper, Kristine L ; Ivy, S Percy ; Vargo, John ; Huang, Marilyn ; Chauhan, Aman ; Orr, Brian ; Chu, Edward ; Kohn, Elise C ; Olawaiye, Alexander B ; Ueland, Frederick ; Christner, Susan M ; Girda, Eugenia ; Sullivan, Stephanie A ; Taylor, Sarah E ; Lin, Yan ; Courtney-Brooks, Madeleine ; Fabian, Denise ; Beumer, Jan H ; Gallion, Holly ; Beriwal, Sushil ; Randall, Leslie M

BACKGROUNDThe addition of IV triapine to chemoradiation appeared active in phase I and II studies but drug delivery is cumbersome. We examined PO triapine with cisplatin chemoradiation.METHODSWe implemented a 3 + 3 design for PO triapine dose escalation with expansion, starting at 100 mg, five days a week for five weeks while receiving radiation with weekly IV cisplatin for locally advanced cervical or vaginal cancer. Maximum tolerated dose (MTD), dose limiting toxicity (DLT), adverse events, pharmacokinetics (PK), pharmacodynamics (PD), and metabolic complete response (mCR) were assessed.RESULTS19/21 patients were DLT evaluable. DLTs included grade 4 neutropenia (n = 2), leukopenia (n = 2), lymphopenia (n = 2), and hypokalemia (n = 1). Grade 3 toxicities at least possibly related were as expected for cisplatin chemoradiation: lymphopenia (n = 12), anemia (n = 10), neutropenia (n = 4), leukopenia (n = 8), decreased platelets (n = 2), hypertension (n = 1), and hyponatremia (n = 1). MTD and RP2D were established at 100 mg. 8/13 evaluable patients had a mCR. Triapine had a bioavailability of 59%. Methemoglobin levels correlated with triapine exposure. Smoking almost doubled CYP1A2 mediated triapine clearance.CONCLUSIONSOral triapine is safe when given with cisplatin chemoradiation, convenient, bioavailable. Exposure is negatively impacted by smoking, and methemoglobin is a biomarker of exposure.CLINICAL TRIAL REGISTRATIONNCT02595879.

2025-06-01·Biochemistry and Biophysics Reports

‘Nelfinavir sensitizes a clinically relevant chemo-radioresistant cervical cancer in-vitro model by targeting the AKT-USP15/USP11-HPV16 E6/E7 axis

Article

作者: Goda, Jayant Sastri ; Gaiwak, Vagmi ; Reddy, Reshma ; Teni, Tanuja

Resistance to standard therapies is a major challenge in managing cervical cancer, often leading to systemic relapse. This study aimed to develop an in-vitro model of chemo-radioresistant cervical cancer that mimics clinical conditions and also explore the therapeutic potential of the repurposed drug nelfinavir, an HIV protease inhibitor. HPV16-positive SiHa cervical cancer cells were subjected to concurrent cisplatin and ionizing radiation, to simulate the clinical treatment regimen for locally advanced cervical cancer. The resulting chemo-radioresistant subline exhibited increased IC₅₀-value, D0 dose, and a higher Resistance Index compared to parent cells, indicating resistance development. Notably, elevated HPV16 E6/E7 expression in resistant sublines suggested a role for HPV16 in resistance acquisition. Treatment with nelfinavir significantly reduced the IC₅₀-value and D0 dose in resistant cells. Additionally, exposure to nelfinavir or AKT inhibitor IV showed significant decrease in AKT, USP15, USP11 and HPV16 E6/E7 proteins. Furthermore, siRNA mediated knockdown of USP15 and USP11 in resistant cells resulted in significant reduction of HPV16 E6 and E7 oncoproteins respectively. Thus, mechanistically nelfinavir sensitized resistant cervical cancer cells by inhibiting the AKT-USP15/USP11-HPV16 E6/E7 pathway. Overall, this study successfully established a chemo-radioresistant SiHa cell model, providing a platform for investigating resistance mechanisms. It also highlights nelfinavir's potential as a therapeutic agent in overcoming chemo-radioresistance in cervical cancer.

121

项与局部晚期宫颈癌相关的新闻（医药）

2025-04-30

·ioncology

全国先进工作者 | 向阳：与妇科肿瘤“扳手腕”的人

庆祝中华全国总工会成立100周年暨全国劳动模范和先进工作者表彰大会4月28日上午在人民大会堂隆重举行。中共中央总书记、国家主席、中央军委主席习近平出席大会并发表重要讲话强调，新时代新征程，必须紧紧围绕党的中心任务，汇聚起工人阶级和广大劳动群众的磅礴力量，脚踏实地、奋发进取、拼搏奉献，一步一个脚印把实现中华民族伟大复兴的宏伟蓝图变成现实。根据《中共中央、国务院关于表彰全国劳动模范和先进工作者的决定》，1670人被授予全国劳动模范称号，756人被授予全国先进工作者称号。北京协和医院妇科肿瘤中心主任、妇儿党总支书记向阳获评全国先进工作者荣誉称号。向阳北京协和医院妇科肿瘤中心主任、妇儿党总支书记、主任医师他39年来始终坚守在妇科肿瘤临床、教学和科研工作第一线，一次次向不治之症发起挑战，帮助众多女性战胜疾病、改善预后、重获幸福。他主持“十四五”重大专项及多项国家自然科学基金，获国家科技进步二等奖、7次获省部级科技成果奖，着力推动学科创新与突破，引领中国妇科肿瘤诊疗的规范化、精准化与同质化发展，让更广大患者受益。他的研究成果获国际高度认可，文章发表在Lancet、Lancet Oncol、Br J Cancer、Eur J Cancer等权威期刊，多项“中国方案”写入国际妇产科联盟（FIGO）、美国国立综合癌症网络（NCCN）等国际权威指南。他就是2025年全国先进工作者，北京协和医院妇科肿瘤中心主任、妇儿党总支书记向阳。▲向阳（左）实施妇科肿瘤联合脏器切除手术患者回来看我最高兴妇科肿瘤是危害女性健康的重要“凶手”。仅宫颈癌、子宫内膜癌和卵巢癌这三大妇科恶性肿瘤，全国每年新发病例接近30万。数十年来，向阳迎难而上、创造生机，用精湛技术、创新方案、规范策略提升妇科肿瘤患者生存率及生存质量，护佑女性健康。▲向阳（左二）带领青年医生查房27岁的杨女士来到北京协和医院时已经是绒癌四期，出现了肺、脑转移。向阳为她制定了详细的治疗方案。经过10余次化疗及其他综合治疗，杨女士不仅重获了新生，更在4年后生下了可爱的女儿，收获了圆满的家庭。只要有机会来到北京，杨女士总要带着女儿回到北京协和医院来看看。“2008年北京奥运会时，还是个7岁的小姑娘。现在长大了，大学都已经毕业了。”向阳欣慰地说：“患者们回来看我，还有许多人寄来孩子们的照片，这是我最珍贵的收获！”向阳常常对青年医生说，临床实践中要时刻谨记，手术刀下是一个活生生的生命，不允许半点差错或失误。医生治病并非炫技，而是希望患者获得更好的结局。一定要牢记治疗的目的是使患者受益，应该用医学技术去适应患者，而非让患者来适应医学技术。持续引领滋养细胞肿瘤诊疗发展1985年，宋鸿钊教授牵头的绒癌根治成果获得国家科技进步一等奖。同年，向阳作为湘雅医学院中的佼佼者被选入北京协和医院实习。他在宋鸿钊、吴葆桢、连利娟、郎景和等大师的带领和熏陶下快速成长，进一步发展和推广滋养细胞肿瘤综合诊治技术。自2005年起，向阳开始担任国际滋养细胞疾病学会（ISSTD）执行委员，并任第18届国际执行主席。接过前辈们的接力棒，向阳带领下的协和妇科肿瘤学始终走在滋养细胞肿瘤诊疗的国际前沿。▲向阳（中）团队召开科研组会为科学规范开展低危病例诊治，向阳牵头开展不同单药治疗方案的多中心随机对照试验。聚焦高危、广泛转移、反复耐药、复发等情况，他牵头“十四五”重大专项等国家级科研项目，开展多项全国多中心临床研究，开展免疫治疗的基础及临床研究，探索化疗联合手术及免疫治疗的综合策略，成果发表在Lancet子刊Lancet Oncol、eClinicalMedicine。他主导的胎盘部位滋养细胞肿瘤多中心研究，优化了保育治疗指征，使晚期患者完全缓解率达87.5%。针对上皮样滋养细胞肿瘤，他明确了其侵袭性显著高于胎盘部位滋养细胞肿瘤，提出不宜保育治疗的策略，填补了研究空白。以5-氟尿嘧啶为核心的联合化疗方案，以及对低危病人进行的分层治疗建议等中国特色方案多次写入国际指南。让中国妇科肿瘤研究得到世界认可作为具有国际影响力的妇科肿瘤学术带头人之一，向阳广泛参与国际学术活动，但不迷信国际权威，以医学家的胆识和眼光，严谨、审慎地开展研究，使中国临床研究得到国际认可，推动国际指南策略改变。2018年，《新英格兰医学杂志》(NEJM)发表的一篇文章指出，早期宫颈癌患者腹腔镜手术比开腹手术的复发率更高，引发高度关注。“中国宫颈癌患者体量大，需要中国自己的高质量数据指导临床实践。”向阳带领团队开展回顾性及前瞻性队列研究，证明采用改良无瘤技术的腹腔镜宫颈癌根治术与开腹手术的肿瘤学结局相同，且腹腔镜手术创伤更小，患者痛苦少、恢复快。该研究作为封面文章发表在2025年2月美国妇产科学会（ACOG）杂志Obstetrics & Gynecology，杂志主编Jason D. Wright专门发表评述，介绍该研究价值。▲向阳团队对腹腔镜与开腹宫颈癌根治术的临床研究作为封面文章刊登在2025年2月美国妇产科学会（ACOG）杂志Obstetrics & Gynecology，杂志主编专门发表评述在宫颈癌免疫治疗方面，向阳作为国际多中心大型临床试验Keynote-A18的亚洲地区牵头人，带领亚洲20余个中心开展随机双盲研究，证明了新治疗方案对局部晚期宫颈癌诊疗的意义，成果2次刊登在Lancet（向阳为第二作者）。他多次受邀出席国际妇产科学术会议，报告中国和亚洲的研究情况，显著提升了中国妇科肿瘤研究的国际影响力。▲向阳作为国际多中心大型临床试验Keynote-A18的亚洲PI，作为第二作者，2次在 Lancet 发表相关成果▲向阳受邀出席国际妇产科学术会议，介绍相关研究成果推动全国诊疗规范化、精准化、同质化妇科肿瘤的早诊早治至关重要。及时发现早期病变，及时干预可显著提高生存率。初次治疗规范，肿瘤完全缓解的概率能显著提升。向阳孜孜不倦地推动中国妇科肿瘤的规范化、精准化、同质化诊疗，作为中华医学会妇科肿瘤学分会候任主委、中国医师协会妇产科分会妇科肿瘤专业委员会主任委员，主导编写多部国家妇科肿瘤诊疗指南，建立全国妇科肿瘤MDT联盟，推动分级诊疗模式与医联体协作，提升基层医院诊疗能力，惠及更多患者，带动全国诊疗能力不断提升。▲2024协和妇科肿瘤学术论坛暨第九届宋鸿钊滋养细胞肿瘤论坛上，《宫颈癌MDT临床实践中国专家共识》发布。向阳（前排左七）在与妇科肿瘤“扳手腕”的数十年里，向阳从未停止守护生命、探索创新的脚步。《“健康中国2030”规划纲要》和《健康中国行动——癌症防治行动实施方案》明确提出，到2030年总体癌症5年生存率提升15%、达到46.6%的目标。对此，向阳充满信心：“一定能找到更多改善预后的突破口，给临床带来更多选择，给患者带去更多希望。”文字 / 傅谭娉蒋芳图片 / 孙良编辑 / 史真真陈恔主编 / 段文利监制 / 吴沛新

IPO

2025-04-26

·微信

ASCO 2025丨一文了解妇科肿瘤口头报告

点上方蓝字“ioncology”关注我们，然后点右上角“…”菜单，选择“设为星标”ASCO 2025 微专辑扫描二维码可查看更多内容2025年美国临床肿瘤学年会（ASCO 2025）将于5月30-6月3日在美国芝加哥举行。日前，ASCO公布了本次大会的摘要题目和大会日程，本刊整理了妇科肿瘤领域的口头报告专场（Oral Abstract Session）和快速口头报告（Rapid Oral Abstract Session）专场标题，供读者参考。口头报告专场TRUST: Trial of radical upfront surgical therapy in advanced ovarian cancer (ENGOT ov33/AGO‐OVAR OP7).TRUST：晚期卵巢癌根治性前期手术治疗试验（ENGOT ov33/AGO‐OVAR OP7）汇报者：Sven Mahner丨慕尼黑路德维希马克西米利安大学医院摘要号：LBA5500Sentinel lymph node biopsy versus pelvic lymphadenectomy in cervical cancer: The PHENIX trial宫颈癌前哨淋巴结活检 vs 盆腔淋巴结清扫术对比：PHENIX试验汇报者：刘继红丨中山大学肿瘤防治中心摘要号：LBA5501Ultrasensitive detection and tracking of circulating tumor DNA (ctDNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 CALLA trial analyses.循环肿瘤DNA（ctDNA）超灵敏检测和追踪及其与局部晚期宫颈癌患者复发和生存的关系：III期CALLA试验分析汇报者：Jyoti Mayadev丨加州大学圣地亚哥医学中心摘要号：5502Patient-reported outcomes (PROs) in locally advanced cervical cancer (LACC): Insights from the OUTBACK trial.OUTBACK试验中局部晚期宫颈癌的患者报告结局(PRO) 汇报者：Linda R. Mileshkin丨彼得·麦卡勒姆癌症中心摘要号：5503Pembrolizumab with chemoradiotherapy in patients with high-risk locally advanced cervical cancer: Final analysis results of the phase 3, randomized, double-blind ENGOT-cx11/GOG-3047/KEYNOTE-A18 study.帕博利珠单抗联合放化疗治疗高危局部晚期宫颈癌患者：III期随机双盲ENGOT-cx11/GOG-3047/KEYNOTE-A18 研究的最终分析结果汇报者：Linda R. Duska丨弗吉尼亚大学医学院摘要号：LBA5504FIRST/ENGOT-OV44: A phase 3 clinical trial of dostarlimab (dost) and niraparib (nira) in first-line (1L) advanced ovarian cancer (aOC).FIRST/ENGOT-OV44：dostarlimab和尼拉帕利一线治疗晚期卵巢癌的III期临床试验汇报者：Anne-Claire Hardy-Bessard丨Armoricain肿瘤中心摘要号：LBA5506ROSELLA: A phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72).ROSELLA：评估relacorilant+白蛋白结合型紫杉醇vs.白蛋白结合型紫杉醇单药治疗铂耐药卵巢癌的III期研究（GOG-3073、ENGOT-ov72）汇报者：Alexander Olawaiye丨匹兹堡大学医学院和麦吉妇女医院摘要号：LBA5507Benmelstobart plus carboplatin/paclitaxel with or without anlotinib, followed by maintenance benmelstobart with or without anlotinib, as first-line treatment for advanced or recurrent endometrial cancer: A randomized, open-label, phase II trial. 贝莫苏拜单抗联合卡铂/紫杉醇±安罗替尼，随后贝莫苏拜单抗±安罗替尼维持治疗用于晚期或复发性子宫内膜癌一线治疗：一项随机、开放标签、II期临床试验汇报者：陈晓军丨上海市第十人民医院摘要号：5508 快速口头摘要专场Cadonilimab plus platinum-based chemotherapy ± bevacizumab for persistent, recurrent, or metastatic cervical cancer: Subgroup analyses of COMPASSION-16.卡度尼利单抗联合含铂化疗±贝伐珠单抗治疗持续性、复发性或转移性宫颈癌：COMPASSION-16 亚组分析汇报者：吴小华丨复旦大学附属肿瘤医院摘要号：5509Nimotuzumab combined with chemotherapy in the first-line treatment for patients with stage IVB, recurrent or persistent cervical squamous cell carcinoma: A multi-center, randomized, double-blind, and controlled study.尼妥珠单抗联合化疗用于IVB期、复发性或持续性宫颈鳞癌一线治疗：一项多中心、随机、双盲、对照研究汇报者：Zexuan Liu丨中国医学科学院肿瘤医院摘要号：5510Primary results of a phase 2 study of cisplatin-sensitized radiation therapy and pembrolizumab for unresectable vulvar cancer.顺铂增敏放射治疗和帕博利珠单抗治疗不可切除外阴癌的II期研究的主要结果汇报者：Oladapo O. Yeku丨麻省总医院、哈佛医学院摘要号：5511Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for endometrial cancer: Longitudinal changes in circulating tumor DNA.度伐利尤单抗联合卡铂/紫杉醇，后续使用度伐利尤单抗±奥拉帕利作为子宫内膜癌的一线治疗：循环肿瘤DNA的纵向变化汇报者：Shannon Neville Westin丨德克萨斯大学MD安德森癌症中心摘要号：5512Phase 2 study of letrozole, abemaciclib, and metformin in estrogen receptor (ER)–positive recurrent endometrial cancer (EC).来曲唑、阿贝西利和二甲双胍治疗雌激素受体(ER)阳性复发性子宫内膜癌的II期研究汇报者：Panagiotis A. Konstantinopoulos丨丹娜—法伯癌症研究所摘要号：5513Safety and preliminary efficacy from a phase 1 study of INCB123667, a selective CDK2 inhibitor, in patients with advanced platinum-resistant and refractory ovarian cancer (OC).I期研究中选择性CDK2抑制剂INCB123667治疗晚期铂耐药/难治性卵巢癌患者的安全性和初步疗效汇报者：Domenica Lorusso丨Agostino Gemelli 大学医院基金会 IRCCS摘要号：5514A phase II trial of pembrolizumab and lenvatinib in recurrent or persistent clear cell ovarian carcinoma (NCT05296512).帕博利珠单抗和仑伐替尼治疗复发性或持续性透明细胞卵巢癌的II期试验汇报者：Joyce F. Liu丨丹娜—法伯癌症研究所摘要号：5515A phase I/II study of the safety and efficacy of intraperitoneal IMNN-001 in combination with neoadjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian cancer (EOC): Updated survival analysis from OVATION-2 trial.评估腹膜内注射IMNN-001联合紫杉醇/卡铂新辅助化疗治疗新诊断晚期上皮性卵巢癌的安全性和有效性的I/II期研究：来自OVATION-2试验的最新生存分析汇报者：Premal H. Thaker丨华盛顿大学医学院摘要号：5516Safety and efficacy of BAT8006, a folate receptor α (FRα) antibody drug conjugate, in patients with platinum-resistant ovarian cancer: Update on the dose optimization/expansion cohort of BAT-8006-001-CR trial.叶酸受体α（FRα）抗体药物偶联物BAT8006用于铂耐药卵巢癌患者的安全性和有效性：BAT-8006-001-CR试验的剂量优化/扩展队列更新汇报者：张松灵丨吉林大学第一医院摘要号：5517（来源：《肿瘤瞭望》编辑部）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。

ASCO会议临床结果临床3期

2025-04-25

·ioncology

袁光文教授：CSCO宫颈癌诊疗指南更新丨2025 CSCO指南会

点上方蓝字“ioncology”关注我们，然后点右上角“…”菜单，选择“设为星标”2025 CSCO指南会微专辑扫描二维码可查看更多内容由中国临床肿瘤学会（CSCO）和北京市希思科临床肿瘤学研究基金会联合主办的“2025 CSCO诊疗指南大会”于4月18-19日在济南召开。国家癌症中心、中国医学科学肿瘤医院妇瘤科袁光文教授代表中国临床肿瘤学会妇瘤专委会汇报了《CSCO宫颈癌的诊疗指南更新》。袁光文教授国家癌症中心中国医学科学院肿瘤医院妇瘤科主任医师博士生导师· 中国临床肿瘤学会（CSCO）妇科肿瘤专委会常委兼秘书长· 国家癌症中心宫颈癌质控专业委员会委员兼秘书· 中国抗癌协会中西整合宫颈癌专业委员会常委· 中国抗癌协会感染性肿瘤专业委员会常委· 中国抗癌协会肿瘤内分泌专业委员会常委· 中国老年学与老年医学学会妇科分会委员· 中国老年保健协会妇科肿瘤专业委员会委员初治宫颈癌治疗前的诊断与评估指南强调对初治宫颈癌患者进行充分评估，根据评估结果选择治疗模式。初治早期宫颈癌的治疗策略—不保留生育对于无保留生育功能要求的早期宫颈癌患者，根据疾病分期推荐A型、B型或C型子宫切除术，不同期别患者的手术范围不同。针对早期宫颈癌的手术治疗，近期两项大型前瞻性研究提示缩小手术范围可达到与传统根治性手术相当的疗效，同时降低手术相关并发症并改善生活质量，但需要术前精准识别低复发风险患者。在采用这种手术策略的研究中，尽管术前已对患者进行综合评估，研究结果显示部分患者术后病理结果与术前评估不符。CSCO指南去年未对此类手术策略作出直接推荐，今年是否将其纳入推荐，尚需进一步研讨。2025年美国妇科肿瘤学会（SGO）年会发布的PHENIX-I研究为前哨淋巴结活检应用于早期宫颈癌患者提供高质量循证医学证据。参考依据PHENIX-I研究：PHENIX-I对比了宫颈癌前哨淋巴结活检（SLNB）和盆腔淋巴结切除术（PL），结果显示在SLNB阴性（未检出前哨淋巴结转移）的情况下，与完成盆腔淋巴结清扫术（PL）相比，省略PL不会损害宫颈癌患者的无病生存期。省略PL可能与腹膜后淋巴结复发率降低及总生存期改善相关。与PL相比，SLNB显示出更优的手术结局，包括手术时间更短、术中失血量更少、手术相关并发症发生率更低。这些研究证据这一进展为早期宫颈癌手术策略的优化提供了新思路。早期宫颈癌术后辅助治疗CSCO指南进一步确认，对于具有中危因素的患者，不推荐含铂同步化疗。参考依据NRG Oncology/GOG-263研究：GOG-263研究是在中危早期宫颈癌患者开展的根治性子宫切除术及淋巴结切除术后辅助放疗对比放化疗的随机III期试验。结果显示，对于接受根治性子宫切除术后具有中等风险因素的宫颈癌患者，辅助放疗联合顺铂化疗并未改善无复发生存（RFS）或总生存（OS）。此外，在放疗期间加入顺铂化疗显著增加3级以上毒性反应。初治晚期宫颈癌的治疗策略NCCN指南相继接纳了KEYNOTE-A18（同步放化疗时加免疫治疗）和INTERLACE（局部晚期宫颈癌同步放化疗之前加诱导化疗）的结果。KEYNOTE-A18方案去年获得中国国家药品监督管理局（NMPA）批准，有望纳入本次CSCO指南更新。值得注意的是两项研究虽然都是阳性结果，但是也增加了不良反应，在选择时一定要注意合适人群的选择。参考依据INTERLACE研究：放化疗前的诱导化疗可使5年无进展生存（PFS）率提高9%，5年OS率提高8%；研究持续随访中。两组患者对单纯放化疗的依从性较高；单纯CRT组的OS与最近发表文献中的OS相似。IC/CRT组的血液学毒性更大，但这并不影响放疗的进行。KEYNOTE-A18研究：与单独同步放化疗相比，帕博利珠单抗联合现代、高质量的CCRT，并在放化疗后继续使用帕博利珠单抗维持治疗，在新诊断、既往未治疗、高风险、局部晚期宫颈癌患者中，PFS、OS和第二次无进展生存期（PFS2）均显示出具有统计学意义和临床意义的改善。帕博利珠单抗联合CCRT的安全性可控，且与各单独治疗已知的安全性一致。在更长时间的随访后未发现新的安全性信号。复发宫颈癌系统性治疗方案近期涌现出包括免疫检查点抑制剂及抗体药物偶联物（ADC）等多种针对复发宫颈癌的新型治疗药物，并陆续获得NMPA批准新适应症，使得复发宫颈癌的一线和二线系统性治疗方案将变得更加丰富。参考依据COMPASSION-16：Ⅲ期COMPASSION-16评估了PD-1/CTLA-4双抗卡度尼利单抗或安慰剂+含铂化疗±贝伐珠单抗一线治疗持续、复发或转移性宫颈癌的疗效和安全性，结果显示卡度尼利单抗组较安慰剂组的PFS和OS均显著延长，并且无论PD-L1表达状态如何，以及是否使用贝伐珠单抗，卡度尼利单抗组的获益在所有预设亚组中均一致。（来源：《肿瘤瞭望》编辑部）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。

CSCO会议