A Single-arm, Phase II Study for Bone Marrow Protection, Safety, and Efficacy of Trilaciclib Combined With Eribulin in Locally Advanced or Metastatic Triple-negative Breast Cancer After at Least Two Prior Chemotherapy Regimens

Triple negative breast cancer (TNBC) has attracted much attention due to its young age of onset, high aggressiveness, lack of clear therapeutic targets and poor clinical prognosis.Eribulin is a novel non-taxane anti-microtubule inhibitor with unique microtubule and non-microtubule anti-tumor mechanism.Myelosuppression is the cause of many cancer chemotherapy-related adverse events, such as infections, sepsis, bleeding, and fatigue, resulting in delayed hospital stays or the need for treatment with hematopoietic growth factors, blood transfusions, and more.In addition, myelosuppression usually leads to a lower dose or longer interval of chemotherapy, which reduces the intensity of chemotherapy and affects the benefit of chemotherapy for patients.Trilaciclib is a highly potent, selective and reversible CDK4/6 inhibitor that protects bone marrow by protecting hematopoietic stem cells and progenitor cells (HSPCs) during systemic chemotherapy.

开始日期2026-11-04

申办/合作机构

中山大学

NCT07473128

/ Recruiting临床3期

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Trial Comparing Efficacy and Safety of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer

The goal of this clinical trial is to compare the efficacy and safety of trilaciclib versus placebo in subjects with limited stage small cell lung cancer. The main question it aims to answer is:
Does trilaciclib have a myeloprotective effect in subject with limited stage small cell lung cancer?
Participants will be randomised to receive either trilaciclib or placebo.

开始日期2026-09-01

申办/合作机构

Pharmacosmos A/S

ChiCTR2600128499

/ Not yet recruiting临床4期IIT

An exploratory study of Trilaciclib for the primary prevention of hematologic toxicity events in neoadjuvant chemotherapy for borderline resectable and locally advanced pancreatic cancer

开始日期2026-07-10

申办/合作机构

复旦大学附属华山医院

100 项与盐酸曲拉西利相关的临床结果

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100 项与盐酸曲拉西利相关的转化医学

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100 项与盐酸曲拉西利相关的专利（医药）

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项与盐酸曲拉西利相关的文献（医药）

2026-10-01·Thoracic Cancer

Efficacy and Safety of Trilaciclib for the Prevention of Chemotherapy‐Induced Myelosuppression in Patients With Solid Tumors: A Systematic Review and Meta‐Analysis

Review

作者: Zhou, Ying ; Tian, Wei ; Liu, Qianxin ; Zhang, Zhuo

ABSTRACT:

Trilaciclib, a cyclin‐dependent kinase 4 and 6 (CDK4/6) inhibitor administered before chemotherapy, reduces chemotherapy‐induced myelosuppression (CIM) in extensive‐stage small cell lung cancer (ES‐SCLC), but its efficacy across solid tumors remains unclear. This meta‐analysis evaluated the efficacy and safety of trilaciclib in solid tumor patients receiving chemotherapy. PubMed, Embase, Cochrane Library, and ClinicalTrials.gov were searched from inception to January 21, 2026. Randomized controlled trials (RCTs) and cohort studies comparing chemotherapy with or without trilaciclib were included. Primary outcomes were severe neutropenia (SN), febrile neutropenia (FN), duration of severe neutropenia (DSN), Grade 3/4 leukopenia, and granulocyte colony‐stimulating factor (G‐CSF) use. Secondary outcomes included other hematologic toxicities, supportive care interventions, and efficacy outcomes. Ten studies involving 1172 patients (six RCTs and four cohort studies) were identified. Trilaciclib significantly reduced SN (OR, 0.14; 95% CI, 0.06–0.31; p < 0.001), FN (OR, 0.19; 95% CI, 0.11–0.36; p < 0.001), Grade 3/4 leukopenia (OR, 0.25; 95% CI, 0.13–0.46; p < 0.001), and G‐CSF use (OR, 0.36; 95% CI, 0.18–0.71; p = 0.0087), and shortened DSN (MD, −2.30 days; 95% CI, −4.28 to −0.31; p = 0.0309). It also reduced Grade 3/4 anemia and thrombocytopenia and decreased use of erythropoiesis‐stimulating agents, red blood cell transfusions, and platelet transfusions. Overall survival showed a borderline improvement (HR, 0.84; 95% CI, 0.71–0.99; p = 0.0373), while no significant differences were observed in progression‐free survival, overall response rate, or non‐hematologic adverse events. Subgroup analyses suggested greater benefit in ES‐SCLC. Overall, trilaciclib before chemotherapy significantly reduced CIM and supportive care needs, with no apparent compromise in antitumor efficacy and more pronounced effects in ES‐SCLC.

2026-07-01·CANCER TREATMENT REVIEWS

Cyclotherapy: exploiting cell-cycle decoupling for selective cancer cytotoxicity and normal-tissue protection

Review

作者: Curigliano, G ; Marsicano, R M ; Izzo, D ; Trapani, D

The therapeutic index of cytotoxic anticancer agents remains intrinsically constrained by the vulnerability of normal proliferating tissues. Unlike antibiotics, whose selectivity transformed infectious disease prognosis, most chemotherapeutics exert non-discriminatory effects on malignant and healthy cycling cells, resulting in dose-limiting toxicities that curtail clinical efficacy. Cyclotherapy represents a strategy first conceptualized in the early 2000s, that seeks to pharmacologically widen this therapeutic window by transiently arresting normal cells in specific phases of the cell cycle, thereby shielding them from phase-specific cytotoxic agents while leaving checkpoint-defective tumor cells susceptible. This review revisits the biological rationale, preclinical foundations, and clinical trajectory of cyclotherapy. Early approaches leveraging p53 activation and MDM2 inhibition demonstrated proof-of-principle but faced translational limitations. More recently, the development of short-acting CDK4/6 inhibitors, particularly trilaciclib, has provided the first clinically approved example of pharmacologic myeloprotection in small-cell lung cancer. However, inconsistent results across tumor types underscore the context-dependency of cyclotherapy, highlighting the critical importance of tumor-specific cell-cycle vulnerabilities, such as RB1 loss and precise pharmacologic scheduling. We propose a mechanistically informed framework for cyclotherapy development based on three determinants: tumor sensitivity to the protective agent, the cell-cycle dependency of treatment-related toxicities, and the phase specificity of the partnered targeted drug. Reframing adverse events according to cycle-dependent versus cycle-independent mechanisms may enable more rational therapeutic pairings and potentially support safe dose escalation. Cyclotherapy should not be regarded as a failed hypothesis prematurely tested, but as an evolving paradigm requiring refined biological stratification and temporal optimization. Properly implemented, it may redefine cytoprotection and expand the therapeutic latitude of modern oncology.

2026-07-01·EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

A decade of progress in small-cell lung cancer (2015–2025): a narrative review

Review

作者: Iaculli, Alessandro ; Ghidini, Antonio ; Petrelli, Fausto ; Dottorini, Lorenzo

INTRODUCTION:

Small-cell lung cancer (SCLC) accounts for 13-15% of lung-cancer diagnoses but nearly one quarter of lung-cancer-related deaths. Until 2015, the combination of platinum-etoposide chemotherapy, thoracic radiotherapy and prophylactic cranial irradiation (PCI) had kept median overall survival broadly stable at ≈ 12 months in extensive-stage (ES-SCLC) and ≈ 24 months in limited-stage (LS-SCLC) disease. We summarise the key therapeutic advances of the last decade.

MATERIALS AND METHODS:

This is a curated narrative review. PubMed/MEDLINE, Embase, ClinicalTrials.gov, FDA and EMA releases and ASCO/ESMO/WCLC abstracts published between January 2015 and May 2025 were searched for phase II/III trials, regulatory approvals and biomarker studies in SCLC. Quantitative pooling was not performed. Practice-changing trials, selected pivotal phase II studies that led to regulatory approval, translational papers that re-defined the molecular taxonomy and informative negative trials were prioritised for in-depth discussion. A PRISMA-style flow diagram (Fig. 1) summarises the selection process.

RESULTS:

Consolidative thoracic radiotherapy improved 2-year OS in ES-SCLC responders (CREST: 13% vs. 3%; HR 0.84, 95% CI 0.69-1.01) and brain-MRI surveillance preserved cognition while replacing routine PCI in patients with ES-SCLC who had access to neuro-imaging. IMpower133 and CASPIAN established first-line chemo-immunotherapy: adding atezolizumab or durvalumab to platinum-etoposide extended median OS by ≈ 2-3 months (IMpower133: 12.3 vs. 10.3 months, HR 0.70, 95% CI 0.54-0.91; CASPIAN: 13.0 vs. 10.3 months, HR 0.73, 95% CI 0.59-0.91) and approximately doubled 18-month survival; 5-year OS now reaches 12-13%. Lurbinectedin produced a 35% response rate in platinum-sensitive relapse in a single-arm phase II study; the confirmatory phase III ATLANTIS trial was negative. Trilaciclib reduced severe chemotherapy-induced myelosuppression. Molecular profiling re-segregated SCLC into ASCL1- (SCLC-A), NEUROD1- (SCLC-N), POU2F3- (SCLC-P) and YAP1/inflamed-defined (SCLC-I) subtypes, supporting the development of subtype-directed trials. DLL3 has re-emerged as a target via the bispecific engager tarlatamab (DeLLphi-301: ORR 40%, mDOR 12 months) and next-generation antibody-drug conjugates. In LS-SCLC, durvalumab consolidation up to 24 months after chemoradiotherapy improved median OS from 33.4 to 55.9 months (ADRIATIC; HR 0.73, 95% CI 0.57-0.93). Maintenance lurbinectedin plus atezolizumab more than doubled median PFS after induction chemo-immunotherapy in IMforte (5.4 vs. 2.1 months; HR 0.54, 95% CI 0.43-0.67) and improved median OS (13.2 vs. 10.6 months; HR 0.73, 95% CI 0.57-0.95). Several phase III trials in this period were negative (KEYNOTE-604, CheckMate-451, CheckMate-331, SKYSCRAPER-02, ATLANTIS, TAHOE, MERU).

CONCLUSIONS:

SCLC therapy has shifted from uniform cytotoxic treatment to a tiered, mechanism-driven algorithm that incorporates PD-L1 blockade, targeted cytotoxics, myeloprotection and refined radiotherapy, raising long-term survival above 20% in selected populations. From a European-practice perspective, current best practice is platinum-etoposide plus a PD-L1 inhibitor for treatment-naïve ES-SCLC, thoracic consolidation radiotherapy in selected responders, lurbinectedin or DLL3-directed clinical trials at relapse, and durvalumab consolidation after chemoradiation in LS-SCLC. Outstanding challenges include a low absolute survival gain from chemo-IO, the absence of validated predictive biomarkers, lineage plasticity, and unequal global access to new agents.

678

项与盐酸曲拉西利相关的新闻（医药）

2026-10-26

·肺癌青委会

2026年10月12-18日 | 肺癌术后管理、软脑膜转移与免疫相关垂体炎病例、EGFR ex20ins脑转移治疗与曲拉西利骨髓保护研究

欢迎关注《肺研周见》。本栏目由北京大学肿瘤医院赵军主任带领的北京医学奖励基金会肺癌青年专家委员会专家组成员联合打造，旨在为中青年肿瘤医生提供精准、高效的前沿情报。不同于传统文献解读，我们依托AI检索策略，关注当周多篇发表在顶级期刊中，锁定最具临床价值的几篇核心研究。希望《肺研周见》能成为一个稳定、可靠的学术信息窗口，为临床实践与科研工作提供有益的支持与启发。 FEIYANZHOUJIAN 1 老年肺癌胸腔镜术后，高流量鼻氧让住院肺部并发症减轻呼吸支持应主动介入术后早期。对接受胸腔镜肺癌切除的老年患者，术后早期的呼吸恢复需要格外照顾。疼痛让深呼吸和咳嗽变得困难，分泌物潴留、肺不张容易随之出现。老年人的呼吸肌力量和生理储备下降，这些问题可能进一步发展为肺部并发症。因此，预防性呼吸支持应尽早进入术后照护安排。高流量鼻氧持续输送加温湿化气体，为这一阶段提供呼吸支持。《Critical Care》发表的一项单中心开放随机试验，检验了它对并发症的影响。研究纳入60至80岁、接受肺叶或肺段切除的Ⅰ至ⅢA期非小细胞肺癌患者。223人随机分组，210人进入改良意向治疗分析，其中高流量组104人，常规吸氧组106人。高流量组的治疗中位时长为67小时。按住院期间每人最严重的一次肺部并发症分级，高流量组出现更严重并发症的优势比为0.50，95%置信区间为0.28至0.91。两组术后住院时间的中位数均为5天。这项试验为老年肺癌患者的早期呼吸支持提供了依据。对符合研究条件的患者，可将高流量鼻氧与镇痛、排痰和早期活动一起安排，把预防并发症落实到术后最初几天。 Source: Prophylactic high-flow nasal oxygen vs. conventional oxygen for prevention of postoperative respiratory complications: a randomized trial Critical Care. PMID 428646732 腰痛按椎间盘突出治疗三个月，一例肺腺癌以马尾综合征起病进行性神经症状应尽早查明病因。对因腰痛、下肢麻木和步态不稳就诊的患者，症状持续加重需要引起重视。若病因被归于腰椎退变，神经功能损害可能继续进展，直至影响行走和大小便功能。症状与腰椎影像不匹配时，应尽早扩大病因排查。《Frontiers in Oncology》报道了一名69岁男性的诊疗经过。他没有咳嗽或咯血，最先出现的就是上述神经症状。早期腰椎平扫MRI上的马尾点状异常被忽略，按椎间盘突出治疗3个月仍未改善。随后发现左下肺肿块，切除病理为伴神经内分泌分化的低分化腺癌。距神经症状起病约4个月时，他已逐渐不能行走，并出现大小便失禁。增强MRI显示广泛线状、结节状软脑膜强化，腰骶段病变呈铸型样充填，包绕马尾神经。家属拒绝腰穿，医生依据临床和影像诊断为很可能的软脑膜转移。软脑膜转移累及神经根时，可以先表现为马尾综合征，肺部症状却不突出。这个病例提醒临床，进行性的神经功能损害需要尽早找到解释。尤其是按腰椎疾病治疗后仍不断恶化的患者，应及时考虑脑及脊柱增强MRI，把肿瘤性软脑膜和神经根受累纳入鉴别。 Source: Leptomeningeal metastasis of lung adenocarcinoma presenting as cauda equina syndrome: a case report and literature review Frontiers in Oncology. PMID 428654313 肺癌免疫治疗后肠梗阻样发作，一例疑似垂体炎经激素治疗好转免疫治疗后的急腹症也要查激素。对接受免疫治疗的肺癌患者，呕吐、腹胀若伴明显乏力和意识改变，需要同时考虑内分泌毒性。这类全身恶化可能被胃肠症状掩盖，影响后续处置，激素检查应尽早进入评估。《Frontiers in Oncology》报道了一名76岁转移性非小细胞肺癌男性的经历。他接受纳武利尤单抗、伊匹木单抗联合卡铂和培美曲塞两个周期后，出现定向障碍和胆汁性呕吐。CT显示胃肠扩张。由于此前做过回肠切除，医生怀疑粘连性肠梗阻，曾考虑再次手术，因全身状况差暂未实施。后续检查发现中枢性甲状腺功能减退和继发性肾上腺功能不全，结合用药经过，医生高度怀疑免疫相关垂体炎。免疫检查点抑制剂可累及垂体，进而使肾上腺和甲状腺激素不足，胃肠动力也可能受到影响。给予糖皮质激素和甲状腺激素后，他的意识及活动能力逐渐恢复，呕吐和腹胀消退。复查CT显示胃肠扩张减轻，最终恢复进食，未行手术。这个病例提示，免疫治疗后的胃肠急症应结合全身表现来判断。肿瘤科、外科与内分泌科尽早并行评估，有助于及时识别需要处理的激素缺乏。 Source: Case Report: Immune checkpoint inhibitor-induced hypophysitis presenting as acute paralytic ileus mimicking mechanical bowel obstruction in a patient affected by advanced non-small cell lung cancer Frontiers in Oncology. PMID 428711834 三例EGFR外显子20插入肺癌，小型脑转移灶在埃万妥单抗联合化疗后消退或缩小小而无症状脑转移值得讨论系统治疗先行。对EGFR外显子20插入突变肺癌患者，脑转移出现后，颅内病灶控制成为新的治疗难题。这类突变对常规EGFR靶向药不敏感，颅内治疗选择相对有限，医生需要寻找能兼顾脑内外病情的系统方案。埃万妥单抗同时靶向EGFR和MET，联合卡铂及培美曲塞已有全身治疗证据。作为大分子抗体，它在颅内的作用也需要通过实际病例观察。《AME Case Reports》报道了日本爱知县癌症中心的3例经历。3名肺腺癌患者均有小而无症状的脑转移，病灶最大径分别为6、5和3毫米。医生没有先行脑放疗，直接给予上述联合方案。其中2例是在试验性靶向治疗后改用二线方案。第一例约6周后多数脑转移灶消失；另外两例分别在治疗10个月和2个月时，MRI上病灶全部消失。第二例在13个月时再次出现颅内和全身进展。这组病例提示，联合方案对小型脑转移灶也可能具有活性。对这类无症状患者，多学科讨论值得认真评估系统治疗先行的选择，并落实规律脑MRI复查。将颅内和颅外病情共同纳入疗效评估，可以为局部治疗时机的判断提供更完整的信息。 Source: Intracranial activity of amivantamab combined with carboplatin and pemetrexed in epidermal growth factor receptor exon 20 insertion-positive non-small cell lung cancer with brain metastases: a report of three cases AME Case Reports. PMID 428716885 曲拉西利荟萃分析更新，小细胞肺癌亚组的骨髓保护信号更清楚骨髓保护应提前进入化疗计划。对广泛期小细胞肺癌患者，化疗还没完成，血细胞就可能先降下来。这可能意味着感染、输血，或下一周期治疗被迫推迟。骨髓保护因此关系到患者能否平稳接受治疗，需要在安排化疗时一并考虑。曲拉西利是一种短效CDK4/6抑制剂，在化疗前使用，可让造血干祖细胞暂时停留在细胞周期的G1期，减少其受到的化疗损伤。《Thoracic Cancer》发表的一项系统综述，汇总了这种预防策略的证据。研究检索截至2026年1月21日，纳入6项随机试验和4项队列研究，共1172名实体瘤患者。其中7项研究聚焦广泛期小细胞肺癌。在重度中性粒细胞减少这一终点，小细胞肺癌亚组共有704人，曲拉西利组349人，对照组355人。各研究观察期内的合并优势比为0.11，95%置信区间为0.06至0.18，研究间统计异质性为0。跨癌种合并结果还记录到较少的重度贫血、血小板减少及输血需求。这些结果支持把骨髓保护提前纳入广泛期小细胞肺癌的治疗计划。结合患者基础血象、既往骨髓抑制经历和化疗方案，尽早评估曲拉西利等保护措施，争取让后续治疗按计划推进。 Source: Efficacy and Safety of Trilaciclib for the Prevention of Chemotherapy-Induced Myelosuppression in Patients With Solid Tumors: A Systematic Review and Meta-Analysis Thoracic Cancer. PMID 42876373 文献检索：LikeMed 解读：韩颖审核：赵军专家介绍赵军北京大学肿瘤医院北京大学肿瘤医院胸部肿瘤中心副主任，胸部肿瘤内一科副主任，主任医师，教授，博导肿瘤内科教研室主任，伦理委员会副主任委员中国老年保健协会肿瘤支持治疗专业委员会主任委员；北京市医学奖励基金会肺癌青年委员会主任委员；北京科创医学发展基金会肺癌专委会主任委员；北京肿瘤学会肺癌专委会副主任委员；北京抗癌协会早癌筛查专委会肺癌学组组长；中国医师协会肿瘤多学科诊疗专业委员会委员；中国医药教育协会疑难肿瘤分会常委；中国医药创新促进会抗肿瘤药物临床研究专业委员会委员；中国抗癌协会呼吸内镜分会委员；精准医学与肿瘤康复专委会常委；中国老年学会老年肿瘤专业委员会委员；国家技术标准创新基地医疗健康大数据专业委员会委员；《中国肺癌杂志》青年编委；《肿瘤防治研究杂志》编委；《中国肿瘤临床杂志》审稿专家。韩颖天津市肿瘤医院天津市肿瘤医院生物治疗科副主任医师，副教授，硕士生导师北京医学奖励基金会肺癌医学青年专家委员会副秘书长。

2026-10-21

·先声药业

先声再明12项研究入选2026年欧洲肿瘤内科学会年会

2026年欧洲肿瘤内科学会（ESMO）年会将于10月23–27日，在西班牙马德里召开。作为与ASCO、WCLC并肩的国际肿瘤学术"风向标"，其入选研究代表当年最具价值的临床进展。先声再明恩维达®、恩立妥®、科赛拉®三款创新药12项研究入选，覆盖肺癌、胆道肿瘤、结直肠癌、宫颈癌、软组织肉瘤等瘤种，以从精准靶向、免疫治疗到骨髓保护的全线突破，展现中国原研实力。恩维达®（恩沃利单抗）六项研究拓展皮下免疫应用边界 1）胆道癌注册Ⅲ期皮下抗PD-L1恩沃利单抗联合GEMOX对比GEMOX一线治疗中国晚期胆道癌的随机开放多中心注册Ⅲ期研究 Subcutaneous anti-PD-L1 monoclonal antibody Envafolimab plus gemcitabine and oxaliplatin (GEMOX) versus GEMOX alone as first-line treatment for advanced biliary tract cancer in Chinese patients: A randomized, open-label, multicenter, registrational phase III trial 发表形式：Rapid Oral（快速口头报告）摘要编号：473RO 研究者：秦叔逵（南京天印山医院）研究结果：462例疗效分析；mOS 10.9 vs 8.6个月（HR 0.723），3年OS率12.5% vs 7.7%；mPFS 5.4 vs 4.5个月；ORR 27.6% vs 20.9%；12个月DOR率33.6% vs 9.6%。 2）广泛期小细胞肺癌恩沃利单抗联合白蛋白紫杉醇及铂类一线治疗广泛期小细胞肺癌的开放标签单臂Ⅱ期研究 Envafolimab Plus Nab-Paclitaxel and Platinum as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (ES-SCLC): An Open-Label, Single-Arm, Phase II Trial 发表形式：Poster（壁报）摘要编号：3828P 研究者：张健（南方医科大学珠江医院）研究结果：32例可评价患者ORR 78.1%、DCR 96.9%，中位PFS 6.3个月，6个月PFS率58.5%，中位OS 17.9个月。≥3 TRAEs occured in 33.3%，无5级TRAE发生。 3）软组织肉瘤恩沃利单抗联合脂质体多柔比星和异环磷酰胺一线治疗晚期软组织肉瘤的Ⅱ期研究 Phase II Study of First-line Envafolimab in Combination with Liposomal Doxorubicin and Ifosfamide for Advanced Soft Tissue Sarcoma 发表形式：Poster（壁报）摘要编号： 3746P 研究者：董颖（浙江大学医学院附属第二医院）研究结果：纳入24例患者：中位PFS 10.4个月，中位OS未达；ORR 38.1%、DCR 85.7%；3–4级TRAE 33.3%，未观察到非预期的免疫相关安全信号。 4）局部晚期结肠癌新辅助恩沃利单抗单药或联合CAPEOX用于局部晚期结肠癌新辅助的前瞻性单中心双队列研究 Envafolimab (anti-PD-L1) as Monotherapy or in Combination with CAPEOX for Neoadjuvant Treatment of Locally Advanced Colon Cancer: A Prospective, Single-Center, Dual-Cohort Clinical Trial (NCT06014372) 发表形式：Poster（壁报）摘要编号：839P 研究者：卢震海（中山大学肿瘤防治中心）研究结果：67例；dMMR/MSI-H队列pCR 48.0%、总体CR 52.0%；MSS/pMMR队列pCR 23.8%；两组手术患者R0切除100%。 5）KRAS G12C mCRC 氟泽雷塞联合西妥昔单抗β±FOLFIRI治疗KRAS G12C突变转移性结直肠癌的CRUCIAL研究 Efficacy and safety of IBI351 plus cetuximabβ ± FOLFIRI in patients with KRAS G12C-mutated metastatic colorectal cancer (the CRUCIAL study) 发表形式：e-Poster（电子壁报）摘要编号：885eP 研究者：袁瑛（浙江大学医学院附属第二医院）研究结果：一线ORR 90.0%、二线ORR 78.6%，两队列DCR均100%；一线/二线分别有60.0%/64.3%患者的肿瘤退缩超过50%；二线≥3级TEAE仅5.6%。 6）老年胆囊癌恩沃利单抗+仑伐替尼+卡培他滨一线治疗不可切除/转移性老年胆囊癌的单臂探索研究 First-Line Envafolimab, Lenvatinib, and Capecitabine for Elderly Patients With Unresectable or Metastatic Gallbladder Cancer: A Single-Arm Exploratory Study 发表形式：e-Poster（电子壁报）摘要编号：499eP 研究者：黄帆（安徽医科大学第一附属医院）研究结果：纳入26例患者：中位PFS 7.3个月、OS 8.3个月，2年OS率19.4%；ORR 40%、DCR 90%；5例转化R0切除（1例pCR）。恩立妥®（西妥昔单抗β）三项研究深耕结直肠癌 1）高危pMMR/MSS局晚直肠癌短程放疗联合mFOLFOX6、信迪利单抗及基因分型指导靶向治疗高危pMMR/MSS直肠癌的CRITⅡ期主要分析 SCRT combined with mFOLFOX6, sintilimab, and genotype-guided targeted therapy in high-risk pMMR/MSS rectal cancer: primary analysis of the multicenter phase II CRIT study 发表形式：Poster（壁报）摘要编号： 3539P 研究者：黄俊（中山大学附属第六医院）研究结果：49例入组；47例手术，pCR 51.1%（野生型57.1%、突变型46.2%），R0 100%；中位随访9.6个月无复发转移；3–4级TRAE＜5%。 2）CRIT-II：随机Ⅲ期研究设计 CRIT-II：短程放疗后mFOLFOX6联合信迪利单抗及基因分型靶向治疗高危pMMR/MSS直肠癌的随机Ⅲ期研究 CRIT-II: a randomized phase III trial of SCRT followed by mFOLFOX6 with sintilimab and genotype-guided targeted therapy in high-risk pMMR/MSS rectal cancer 发表形式：e-Poster（电子壁报）摘要编号： 3583eTiP 研究者：黄俊（中山大学附属第六医院）研究设计：基于CRIT阳性结果推进的Ⅲ期研究设计入选，目标为高危pMMR/MSS局晚直肠围手术期模式提供高级别证据。 3）一线pMMR RAS/BRAF WT mCRC 西妥昔单抗β联合呋喹替尼±免疫治疗一线pMMR RAS/BRAF野生型不可切除mCRC的Ⅱ期研究 CONCEPT (COmbinatioN of CEtuximab Plus fruquintinib Treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer 发表形式：e-Poster（电子壁报）摘要编号：890eP 研究者：丁克峰（浙江大学医学院附属第二医院）研究结果：可评估人群中，双药联合组疗效未达到预期，西妥昔单抗β联合呋喹替尼和PD-1抑制剂ORR 83.3%，西妥昔单抗β联合呋喹替尼和PD-1/CTLA-4 抑制剂组ORR 66.7%；主要TRAE为皮疹/口腔炎/乏力，无5级TRAE。科赛拉®（曲拉西利）三项研究夯实“骨髓保护”价值 1）宫颈癌同步放化疗骨髓保护 Trilaciclib预防局部晚期宫颈癌诱导化疗及同步放化疗化疗诱导骨髓抑制的前瞻性单臂Ⅱ期研究 Trilaciclib for the prevention of chemotherapy-induced myelosuppression during induction chemotherapy followed by chemoradiotherapy in locally advanced cervical cancer: A prospective, single-arm, phase II study 发表形式：Poster（壁报）摘要编号： 3930P 研究者：赵丽娜（西京医院）研究结果：44例接受诱导化疗、39例完成同步放化疗；诱导化疗阶段CIM 65.91%（G3 6.82%），同步放化疗阶段CIM 92.31%（G3 7.69%）。 2）局限期小细胞肺癌化疗序贯放疗曲拉西利用于局限期小细胞肺癌一线化疗序贯胸部放疗的骨髓保护：探索性非随机对照研究 Trilaciclib for myeloprotection in limited-stage small cell lung cancer receiving first-line chemotherapy with sequential thoracic radiotherapy: an exploratory non-randomized controlled study 发表形式：Poster（壁报）摘要编号：3832P 研究者：白静慧（辽宁省肿瘤医院）研究结果：曲拉西利组21例、对照组21例；≥3级中性粒细胞减少4.8% vs 15.0%，≥3级血小板减少/贫血均为0% vs 5.0%；ORR 85% vs 80%。 3）多瘤种真实世界联合免疫治疗/放疗曲拉西利联合化疗跨实体瘤的骨髓保护真实世界回顾性研究 Myeloprotective efficacy of trilaciclib combined with chemotherapy across solid tumor types: a real-world retrospective study 发表形式：e-Poster（电子壁报）摘要编号：4054eP 研究者：张玉宇（吉林大学第一医院）研究结果：78例实体瘤，48.7%同步免疫、43.6%同步放疗；10个周期内3–4级白细胞减少≤3.2%、中性粒细胞减少≤8.3%、血小板减少≤1.1%；ORR 65.4%、DCR 96.2%，全程ALC＞1.0×10⁹/L。先声再明是先声药业集团（2096.HK）旗下专注于抗肿瘤创新药研发、生产和商业化的生物医药公司，致力于以科学创新和突破性技术，打造高价值创新管线，已上市产品包含恩泽舒®、科赛拉®、恩维达®、恩度®、恩立妥®5款创新药。先声再明与全球合作伙伴的协同创新，为临床提供更有效的治疗手段，让更多肿瘤患者再现生机与光明。编辑 | 李逸玲审校 | 赵华明朱雯审核 | 陈洁瑛

2026-10-18

·吉林玖禄健康咨询平台

鲍主任科普 | ASCO重磅｜国产DLL3靶向ADC来袭！BL-M14D1打破小细胞肺癌、神经内分泌癌后线治疗困局

ASCO重磅｜国产DLL3靶向ADC来袭！BL-M14D1打破小细胞肺癌、神经内分泌癌后线治疗困局导语：小细胞肺癌（SCLC）、高级别神经内分泌癌（NEC）素来是恶性肿瘤里的“硬茬”：初治化疗见效快，但绝大多数患者短时间复发耐药，后线缺药、生存期惨淡。2026全球顶尖肿瘤大会ASCO上，国产原研新型DLL3-ADC药物BL-M14D1临床数据重磅公布，在经过多线治疗的晚期患者身上实现超高缩瘤率，为无数难治患者开辟全新出路。同济大学附属东方医院教授牵头的I期研究（摘要3001）登上大会口头汇报，国产新药再一次站上全球肿瘤学术舞台。科普医师鲍慧峥三级主任医师，吉林省卫计委拔尖创新人才；国家淋巴瘤质控专家委员会委员，中国医药教育协会淋巴瘤分会主任委员，CSCO淋巴瘤专家委员会常委，中国女医师协会靶向治疗专业委员会副主任委员。以医者初心，做有温度的肿瘤科普，拆解难懂医学、聚焦肿瘤前沿、讲解规范用药、分享饮食调养。传递专业靠谱的肿瘤知识，用专业守护健康，用温暖陪伴患者，让家属从容面对，科学抗癌，温柔同行。难治癌困局：小细胞肺癌&神经内分泌癌为何治起来这么难？ PART01 小细胞肺癌SCLC 占全部肺癌13%~15%。高度依赖吸烟，癌细胞增殖迅猛、早期就容易出现脑、肝、骨多发转移。 - 一线化疗±免疫短期有效，但80%~90%患者1年内复发耐药； - 复发后传统化疗有效率不足20%，靶向药稀缺，长期生存常年停滞不前，是肺癌领域最难突破的亚型之一。 PART02 神经内分泌癌NEC 全身多器官均可发病，恶性程度比肩小细胞肺癌，同样极易耐药，既往无针对性靶向方案，后线只能反复更换化疗，副作用大、疗效有限。 PART03 DLL3：救命黄金靶点 DLL3蛋白在85%以上SCLC、绝大多数NEC癌细胞表面特异性高表达，正常组织极少表达，是精准治疗的绝佳突破口，也是近几年全球新药研发热门靶点。 BL-M14D1：国产自研“生物导弹ADC”，精准定点爆破癌细胞 BL-M14D1是我国自主研发靶向DLL3的新一代ADC（抗体偶联药物），通俗理解就是一枚带精准导航的抗癌导弹，三大部件各司其职：如何作用 1. 人源化DLL3抗体=GPS导航：精准锁定肿瘤表面DLL3靶点，只找癌细胞，不盲目攻击健康细胞； 2. 稳定可酶切连接子=安全锁：血液里牢牢锁住毒素，不在正常器官释放毒性；只有进入癌细胞内才断裂； 3. 拓扑异构酶抑制剂Ed-04=重磅炸药：进入肿瘤细胞后释放强效毒素，破坏癌细胞DNA、直接杀灭肿瘤。对比传统化疗：化疗无差别杀伤全身细胞，脱发、骨髓抑制频发；BL-M14D1定向投药，疗效更强、全身性毒副作用大幅下降。 ASCO硬核临床数据：多线耐药患者，超9成肿瘤缩小本次I期临床（NCT06505824）截至2026年3月，总计入组127例晚期患者：SCLC 87例、NEC 40例，平均年龄60岁，几乎全部经过化疗、免疫等多线治疗失败，采用3周一次静脉给药（4.0/4.5mg/kg为临床优选剂量）。小细胞肺癌（SCLC）亮眼数据 - 客观缓解率ORR：71.4%，确认缓解cORR 60.7%，疾病控制率DCR高达94.0%； - 中位无进展生存期mPFS：7.1个月； - 4.0mg/kg组94.1%、4.5mg/kg组94.7%患者肿瘤缩小。肿瘤平均最大降幅分别-52.5%、-46.4%过半患者肿瘤缩小超一半。神经内分泌癌（NEC）惊艳结果 - ORR 55.9%，确认缓解cORR38.2%，DCR94.1%；6个月无进展生存率56.7%； - 85.3%患者出现肿瘤缩小，肿瘤平均缩小幅度-39.0%。全人群汇总总共有91.5%（108/118）受试患者肿瘤实现不同程度缩小，整体中位缩瘤幅度47.4%，在多线耐药难治肿瘤中，这个疗效数据全球领先。安全性：不良反应可控，停药率仅2.4% BL-M14D1整体耐受优秀，副作用以可控的血液毒性为主： - 常见不良反应：白细胞、中性粒细胞、血小板下降（发生率50%~60%，大多1~2级轻症）； - ≥3级不良反应占比30%~40%，使用升白针、骨髓保护剂（曲拉西利）即可对症管理； - 因不良反应永久停药仅3例（2.4%）；仅高剂量6.0mg/kg出现1例3级间质性肺病，4.5mg/kg出现1例可疑药物相关败血症死亡；5.0mg/kg定为最大耐受剂量，4.0~4.5mg/kg是后续II/III期推荐最优剂量。新药研发进度：III期全球试验启动，未来一线优选可期基于I期突破性疗效，研发管线全速推进： 1. 全球多中心III期临床试验正式启动，方案设计BL-M14D1±免疫药物头对头对标当前一线标准方案，面向初治广泛期小细胞肺癌，全球多国同步招募受试者，未来有望改写一线指南； 2. 同步布局NEC一线、后线、联合免疫治疗多项临床探索； 3. 未来落地上市后，从“后线救命药”逐步前移至初诊一线用药，改变SCLC/NEC全周期治疗格局。患者就医实用科普指南 1. 确诊SCLC/NEC，务必完善DLL3检测晚期小细胞肺癌、全身各部位来源神经内分泌癌，病理除常规指标外，建议加做DLL3免疫组化检测，只要DLL3阳性表达，就存在使用BL-M14D1同类靶向ADC的机会。 2. 多线耐药患者怎么争取用药咨询三甲医院肿瘤科，报名BL-M14D1全国III期临床试验，符合入组条件可免费使用试验新药；密切跟进药品上市进度，新药获批后纳入临床常规方案。 3. 未来治疗新方向未来ADC+PD-L1免疫联合方案将成为主流探索方向，进一步提升初治患者治愈率、拉长生存周期。结语从长期无靶向可用，到国产原研DLL3-ADC凭硬核数据登顶ASCO，BL-M14D1的突破，是中国抗肿瘤新药创新的缩影。曾经反复化疗、无药可选的小细胞肺癌与神经内分泌癌患者，终于迎来精准靶向新时代。 ⚠️温馨提示：本文内容基于2026ASCO公布I期临床研究数据，药物尚未正式获批上市，所有治疗方案请谨遵肿瘤科医生指导，切勿自行购药用药。 #DLL3-ADC #肿瘤新疗法 #肿瘤治疗 #医疗科普 #肿瘤科普 #国产DLL3靶向ADC #新药科普 #小细胞肺癌点击查看作者更多精彩内容鲍主任在线咨询：吉林玖禄健康咨询平台合集：乳腺癌科普合集☜ 合集：胃癌&肠癌科普合集☜ 合集：肺癌科普合集☜ 合集：淋巴瘤科普合集☜ 合集：指南共识☜ 如果您喜欢鲍医生的医疗科普内容请关注我们给我们一点支持~ 吉林玖禄健康咨询平台科普说明本文为健康科普，不替代个体化诊疗方案具体用药与治疗请遵医嘱

抗体药物偶联物ASCO会议

100 项与盐酸曲拉西利相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D11987	盐酸曲拉西利	L01XE L01E V03AF12	DB15442

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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	G1 Therapeutics, Inc.	2022-07-12
化疗引起的骨髓抑制	美国	Pharmacosmos A/S	2021-02-12

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适应症	最高研发状态	国家/地区	公司	日期
局限期小细胞肺癌	临床3期	中国	先声再明医药股份有限公司	2026-06-04
三阴性乳腺癌	临床3期	中国	G1 Therapeutics, Inc.	2021-12-07
转移性三阴性乳腺癌	临床3期	美国	G1 Therapeutics, Inc.	2021-05-14
转移性三阴性乳腺癌	临床3期	中国	G1 Therapeutics, Inc.	2021-05-14
转移性三阴性乳腺癌	临床3期	澳大利亚	G1 Therapeutics, Inc.	2021-05-14
转移性三阴性乳腺癌	临床3期	保加利亚	G1 Therapeutics, Inc.	2021-05-14
转移性三阴性乳腺癌	临床3期	法国	G1 Therapeutics, Inc.	2021-05-14
转移性三阴性乳腺癌	临床3期	摩尔多瓦	G1 Therapeutics, Inc.	2021-05-14
转移性三阴性乳腺癌	临床3期	波兰	G1 Therapeutics, Inc.	2021-05-14
转移性三阴性乳腺癌	临床3期	俄罗斯	G1 Therapeutics, Inc.	2021-05-14

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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


ChiCTR2500110354 (ESMO2026)	临床2期	局部晚期宫颈癌	44	Trilaciclib 240 mg/m2 + Trilaciclib 240 mg/m2um-based chemotherapy	憲製網鏇艱鹹糧簾襯襯(網鬱築製築鹽糧鏇糧網) = 獵顧鑰範蓋夢簾醖積遞餘製顧壓憲網構醖獵鬱 (築壓鑰廠製窪壓獵選壓 ) 更多	积极	2026-10-23
WCLC2026	N/A	非小细胞肺癌	40	Trilaciclib 240 mg/m2	範鏇鑰遞齋鹹夢襯膚淵(衊餘選範夢醖獵遞醖遞) = 築範夢艱積襯製蓋淵鹽簾鏇襯願夢餘鏇衊觸衊 (醖醖顧廠範艱壓蓋蓋構, 2.8 ~ 5.6)	积极	2026-09-12
ChiCTR2500097520 (ASCO2026)	临床4期	进展期胃腺癌 \| 晚期胃食管交界处腺癌辅助 \| 一线	204	Trilaciclib + TrilaciclibOLFOX ± immune checkpoint inhibitors (ICIs) ± trastuzumab	夢顧積憲淵簾製鑰觸願(選製網齋襯艱願製積顧) = 顧構積顧鑰積觸齋鬱淵鹽觸窪糧夢積觸糧膚選 (壓積願範襯餘製構遞簾 ) 更多	积极	2026-05-29
				Trilaciclib + TrilaciclibOLFOX ± immune checkpoint inhibitors (ICIs) ± trastuzumab	夢顧積憲淵簾製鑰觸願(選製網齋襯艱願製積顧) = 顧憲選壓範壓網鹽範構鹽觸窪糧夢積觸糧膚選 (壓積願範襯餘製構遞簾 ) 更多
NCT06698965 (ESMO_ELCC2026)	临床2期	广泛期小细胞肺癌一线	52	Trilaciclib 240 mg/m + Envafolimab + EC	構選鏇夢鏇壓遞鑰襯獵(襯簾遞鏇獵夢顧壓顧鹹) = 艱蓋餘衊選糧製鏇觸築淵範構鹹夢窪廠網鬱糧 (淵築鹹膚憲廠觸構膚壓 ) 更多	积极	2026-03-25
				Envafolimab + EC	構選鏇夢鏇壓遞鑰襯獵(襯簾遞鏇獵夢顧壓顧鹹) = 鑰鏇顧範窪鏇鹹糧醖餘淵範構鹹夢窪廠網鬱糧 (淵築鹹膚憲廠觸構膚壓 ) 更多
ASCO_GI2026	临床2期	复发性食管鳞状细胞癌一线	10	Carboplatin (AUC=4-6, IV, Q3W)Paclitaxel (175 mg/m2, IV, Q3W)Trilaciclib (240 mg/m2, IV, Q3W) + Carboplatin (AUC=4-6, IV, Q3W)Paclitaxel (175 mg/m2, IV, Q3W)Trilaciclib (240 mg/m2, IV, Q3W) + Carboplatin (AUC=4-6, IV, Q3W)Paclitaxel (175 mg/m2, IV, Q3W)Trilaciclib (240 mg/m2, IV, Q3W) + Carboplatin (AUC=4-6, IV, Q3W)Paclitaxel (175 mg/m2, IV, Q3W)Trilaciclib (240 mg/m2, IV, Q3W) (Metastatic/recurrent esophageal squamous cell carcinoma)	衊觸襯鬱範顧獵鹽網糧(願鹹鬱夢獵範遞蓋築網) = Other AEs were mainly grade 1-2, including decreased appetite (50%), fatigue (40%), headache (40%), and alopecia (10%). 製獵繭憲鹽鬱窪窪壓夢 (鹹窪積齋鏇齋積壓築蓋 ) 更多	积极	2026-01-08
ChiCTR2500097520 (ESMO2025)	临床2期	胃腺癌 \| 胃食管交界处腺癌辅助 \| 一线	115	Trilaciclib (Cohort 1)	憲觸壓艱鹽艱積夢艱餘(繭築鑰鬱範網鹽鏇構範) = Trilaciclib-related adverse events were limited to 2 cases of phlebitis, with no new safety signals 繭鏇鹹觸鹽構積餘餘壓 (壓構醖夢廠製獵膚憲繭 )	积极	2025-10-17
				Trilaciclib (Cohort 2)
NCT06955156 (ESMO2025)	临床2期	晚期三阴性乳腺癌新辅助	28	Trilaciclib (240mg/m) + anti-PD-1-antibody + nab-paclitaxel + carboplatin	獵積夢夢淵範簾顧鏇繭(鹹鬱顧積獵鏇構憲鹽獵) = 遞網襯餘夢淵廠繭艱餘範衊積糧鑰製窪窪築憲 (築鹽憲繭蓋襯積鹹醖範 ) 更多	积极	2025-10-17
NCT06698965 (ESMO2025)	临床2期	小细胞肺癌	19	Trilaciclib + Etoposide + Carboplatin + Envafolimab	鹹簾鏇襯選鏇襯願鹹鑰(壓顧網鑰衊願餘憲糧構) = 簾獵窪蓋積製獵獵蓋艱鹽繭膚壓糧齋淵鬱齋願 (餘襯蓋齋選鹹網蓋鏇窪 ) 更多	积极	2025-10-17
				Etoposide + Carboplatin + Envafolimab	鹹簾鏇襯選鏇襯願鹹鑰(壓顧網鑰衊願餘憲糧構) = 鬱鹽膚窪遞簾壓醖窪廠鹽繭膚壓糧齋淵鬱齋願 (餘襯蓋齋選鹹網蓋鏇窪 ) 更多
NCT05978648 (ESMO2025)	临床2期	早期乳腺癌辅助 HR-negative \| HER2- positive	89	Epirubicin/cyclophosphamide followed by weekly paclitaxel+Trilaciclib (Triple-negative breast cancer (TNBC))	網鏇鬱鹽糧鏇願遞獵簾(壓鬱繭網糧艱鬱糧廠淵) = 簾繭衊鹹積蓋簾築鑰遞範願襯蓋淵餘鑰糧蓋遞 (夢餘淵壓廠廠鑰鹽衊繭 ) 更多	积极	2025-10-17
				Docetaxel/carboplatin/trastuzumab ± pertuzumab+Trilaciclib (HER2-positive breast cancer)	網鏇鬱鹽糧鏇願遞獵簾(壓鬱繭網糧艱鬱糧廠淵) = 積窪製顧願範壓鹽膚構範願襯蓋淵餘鑰糧蓋遞 (夢餘淵壓廠廠鑰鹽衊繭 ) 更多
ASTRO2025	临床2期	局限期小细胞肺癌	18	Trilaciclib	簾衊鏇簾醖製繭構窪襯(憲醖築遞鹹繭繭壓糧廠) = 蓋簾餘構憲獵積齋艱窪願齋淵觸壓鹹艱觸觸廠 (顧蓋構顧醖齋齋糧觸壓 ) 更多	积极	2025-09-27