An Open-label, Single-arm, Single-center Exploratory Clinical Study of Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Breast Cancer

This is an open-label, single-arm, single-center,exploratory clinical study.

开始日期2026-09-01

申办/合作机构

河北医科大学第四医院

NCT05128734

/ Not yet recruiting临床2期IIT

A Randomized Phase II Study of Temozolomide Monotherapy or in Combination With Olaparib in Patients With METHYLATED 06-Methylguanine-DNA Methyltransferase (MGMT) Pre-Treated Triple Negative Breast Cancer (TNBC)

This is a randomized phase II study to evaluate the disease control rate (DCR) of patients with metastatic or locally advanced METHYLATED 06-methylguanine-DNA methyltransferase (MGMT) with triple-negative breast cancer (TNBC) treated with Temozolomide ± Olaparib. Patients will be randomized 1:1 to Treatment Arm 1 (temozolomide treatment) or Arm 2 (temozolomide plus olaparib treatment).

开始日期2026-04-01

申办/合作机构

AHS Cancer Control Alberta

NCT07187674

/ Not yet recruitingN/AIIT

Single Arm, Prospective, Small Sample, Exploratory Clinical Study on the Neoadjuvant Treatment of Early High-risk Triple Negative Breast Cancer With HRD Positive With Iparomlimab and Tuvonralimab(QL1706)Combined With Olaparib and Paclitaxel

Breast cancer is one of the most common malignant tumors in women, accounting for the first cancer-related death cause in women. In recent years, the incidence has gradually increased, and the trend is younger. In 2022, the estimated number of new cases of female breast cancer worldwide is 2.389 million, and the estimated number of deaths is 666000. Triple negative breast cancer (TNBC) refers to breast cancer that is negative for estrogen receptor, progesterone receptor and human epidermal growth factor receptor 2, accounting for about 10% - 20% of malignant breast tumors. . At present, chemotherapy is still the main means of clinical treatment of TNBC, but the heterogeneity of TNBC in molecular level, pathology and clinical characteristics leads to different sensitivity of patients to different chemotherapeutic drugs, especially the sensitivity of most elderly patients to chemotherapeutic drugs is not high, and the prognosis is poor.
The development of immunotherapy in the field of breast cancer has witnessed the continuous deepening of medical understanding of cancer treatment. In the past, breast cancer was often regarded as a "cold tumor" insensitive to immunotherapy, but with the deepening of research, immunotherapy gradually occupied an important position in the treatment of breast cancer. The ongoing research hopes to identify patients who may benefit more from immunotherapy according to their respective tumor immune microenvironment.
Its mechanism of action mainly includes two aspects: one is to restore the normal recognition and attack ability of the immune system to tumor cells and break the immune escape mechanism of tumor cells; The second is to stimulate a lasting immune response, so that the immune system can continuously monitor and clear tumor cells.
Therefore, this study intends to evaluate the efficacy and safety of Iparomlimab and tuvonralimab combined with olaparib and paclitaxel in the neoadjuvant treatment of early high-risk TNBC with HRD positive.
It is planned to enroll 20 subjects. After enrollment, the subjects will receive six cycles of combination therapy with olaparib and docetaxel. Take 3 weeks as a treatment cycle until the treatment termination event specified in the protocol occurs, and the subject will continue to conduct postoperative efficacy and safety visits after the end of treatment.
After neoadjuvant treatment, according to the routine treatment process of breast cancer, the subject will receive breast cancer surgery; After surgical treatment, according to the residual breast lesions of the patient, the attending physician and the subject will agree on the subsequent treatment plan.

开始日期2025-12-30

申办/合作机构

哈尔滨医科大学

100 项与奥拉帕利相关的临床结果

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100 项与奥拉帕利相关的转化医学

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100 项与奥拉帕利相关的专利（医药）

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3,903

项与奥拉帕利相关的文献（医药）

2026-12-31·CANCER BIOLOGY & THERAPY

Evaluating carboplatin and PARP inhibitor combination efficacy using high-grade serous carcinoma spheroids and organoids

Article

作者: Tomas, Emily J. ; Davis, Jennifer ; Ramos Valdes, Yudith ; Shepherd, Trevor G.

BACKGROUND:

PARP inhibitors (PARPis) are new targeted agents that exploit homologous recombination DNA repair deficiencies (HRDs), which are present in 50% of high-grade serous carcinoma (HGSC) cases. Currently, olaparib is approved as maintenance therapy for BRCA1/2-mutated HGSC, and niraparib is approved for platinum-sensitive recurrent disease. However, research is currently expanding their potential as front-line agents or in combination with carboplatin, a standard HGSC chemotherapeutic.

METHODS:

Immortalized ovarian cancer (iOvCa) cell lines, developed from HGSC patient ascites, were treated with carboplatin, olaparib and niraparib to determine their sensitivity. Immunofluorescence analysis of RAD51 was conducted for HRD testing of all the cell lines. The cell lines were cultured as three-dimensional organoids and spheroids to mimic tumor growth and metastasis, respectively, and then treated to assess the effects of different drug combinations.

RESULTS:

The half-maximal inhibitory concentrations of olaparib and niraparib varied across our iOvCa cell lines, with iOvCa195 BRCA1-mutant line exhibiting the expected high sensitivity to both PARPis. Direct combination of carboplatin with olaparib or niraparib enhanced cell killing, yet achieved cell viability levels to those of carboplatin alone. In sequential experiments, carboplatin followed by either PARPi or vice versa showed no significant difference in cell viability to carboplatin alone, except in iOvCa195 organoids when treated with a PARPi first.

CONCLUSIONS:

Overall, first-line carboplatin treatment remains ideal, yet there may be select utility for PARPi prior to chemotherapy. Using patient-derived tumor models such as spheroids and organoids may provide insights for on-going and future clinical trials to enhance therapeutic outcomes for HGSC patients.

2026-12-01·MOLECULAR BIOLOGY REPORTS

Targeting SRPK1 to regulate alternative splicing in prostate cancer: the roles of MALAT1 and TUG1

Article

作者: Basera, Afra ; Dlamini, Zodwa ; Alabi, Babatunde Adebola ; Gabada, Linomtha ; Marima, Rahaba

BACKGROUND:

Prostate cancer (PCa) is a leading cause of cancer-related mortality, with significant racial disparities in outcomes. Long non-coding RNAs (lncRNAs) MALAT1 and TUG1 are implicated in oncogenic pathways. Aberrant RNA splicing, a hallmark of cancer, is often driven by dysregulation of serine-arginine protein kinase 1 (SRPK1), a key spliceosome regulator. The relationship between lncRNAs of splicing factors in cancer pathways remains underexplored, and thus, this study aimed to elucidate the roles of MALAT1 and TUG1 lncRNAs in relation to the SRPK1 inhibitor SPHINX31 in PCa.

METHODS:

Bioinformatics tools were used to analyze interactions between` MALAT1, TUG1, relevant miRNAs, and target genes. A resazurin assay assessed PCa cell viability (PC-3 vs. HEK293) in response to SPHINX31 at 24 and 48 h. RT-qPCR was used to quantify MALAT1 and TUG1 lncRNAs expression levels.

RESULTS:

The Alamar Blue assay indicated a time-dependent reduction in PC3 cell viability with 3 µM SPHINX31, particularly at 48 h. RT-qPCR revealed significant regulation of MALAT1 and TUG1, highlighting SRPK1's role in RNA pathways critical for tumor survival. SPHINX31 induced similar cytotoxic effects in HEK293 cells, illustrating the need for selective tumor specificity. MALAT1 expression was upregulated at 24 h, followed by a decline at 48 h, indicating cumulative cellular stress in PC-3 cells.

DISCUSSION:

This study demonstrated that SRPK1 inhibition alters lncRNA expression and splicing-related events in PCa. These findings highlight SPHINX31's potential as a therapeutic agent, especially in combination with treatments like Olaparib, necessitating further optimization for selectivity and reduced off-target effects.

2026-06-01·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Boolean network-based identification of optimal drug combinations for prostate cancer

Article

作者: Datta, Aniruddha ; Kumar, Addanki Pratap ; Bhattacharjee, Pranabesh

Prostate cancer is one of the most common cancers among men in the United States and is a leading cause of cancer-related deaths and the second most common cancer in men worldwide. In this study, we used a Boolean network model to analyze prostate cancer signaling pathways and to identify optimal drug combinations for precision therapy. By integrating publicly available biological signaling pathway data with recent research findings, we developed a comprehensive model that represents protein-protein interactions, gene mutations, and pathway dysregulation. Faults induced by mutations were modeled using the "stuck at 0" or "stuck at 1" fault paradigms, capturing the impact of genetic alterations on pathway behavior. The model was simulated across various drug combinations to determine which therapies could most effectively alleviate the aberrant signaling caused by specific mutations. To quantify therapeutic efficacy, we calculated a Size Difference (SD) score, a metric analogous to Hamming distance, measuring the deviation from normal, for each drug combination and fault scenario. The results revealed that drug combinations involving Berberine, Docetaxel, Olaparib, and Enzalutamide showed promising prediction efficacy (more than 90 %), indicating higher therapeutic potential. A distinguishing feature of this work is that, in addition to the standard prostate cancer drugs, we have included Berberine, a non-toxic natural compound with beneficial effects. These computational findings provide a framework for future experimental and clinical validation, which is necessary to confirm the therapeutic relevance of the predicted drug combinations.

1,745

项与奥拉帕利相关的新闻（医药）

2026-01-27

·PRNewswire

Kazia Therapeutics Reports Encouraging Preliminary Clinical Responses in Ongoing Phase 1b Study of Paxalisib in Late-Stage Metastatic Triple-Negative Breast Cancer

SYDNEY, Jan. 27, 2026 /PRNewswire/ -- Kazia Therapeutics (NASDAQ: KZIA), today provided a clinical update from its ongoing Phase 1b study evaluating paxalisib in combination with pembrolizumab and chemotherapy in patients with late-stage (Stage IV), metastatic triple-negative breast cancer (TNBC). To date, three patients with metastatic TNBC treated with paxalisib-based regimens have demonstrated meaningful clinical responses, including two partial responses (PRs) in trial participants and one confirmed complete metabolic response (CR) in a patient treated under an expanded access program. Clinical Highlights 2 of 2 evaluable patients enrolled in the Phase 1b trial achieved partial responses One advanced metastatic TNBC patient achieved a confirmed complete metabolic response following re-treatment with pembrolizumab/chemotherapy plus paxalisib (under an expanded access protocol) Responses observed in patients with visceral disease and multi-organ metastases Median time on treatment to date is approximately 6.1 months, with all patients continuing on therapy at the time of this update Paxalisib continues to demonstrate a generally favorable safety and tolerability profile when combined with pembrolizumab and chemotherapy at the 30 mg daily dose The ongoing Phase 1b trial is a multi-center, open-label, randomized study initiated in June 2025 designed to evaluate the safety, tolerability, and preliminary clinical activity of paxalisib in patients with advanced breast cancer, including TNBC, in combination with either: Pembrolizumab plus chemotherapy (current standard-of-care first-line regimen) or Olaparib (advanced breast cancer patients with BRCA mutations). Eligibility for the pembrolizumab-containing cohort required PD-L1–positive disease (CPS ≥10), consistent with standard-of-care practice in metastatic TNBC. Patient 1 – Partial Response A 61-year-old female with metastatic TNBC involving the left upper lobe of the lung, initiated treatment with paxalisib (30 mg daily) in combination with pembrolizumab and gemcitabine/carboplatin in June 2025. After nine cycles of therapy, serial imaging demonstrated continued tumor reduction at each assessment, culminating in a partial response by iRECIST criteria. The patient remains active on study. Patient 2 – Partial Response with Complete Resolution of a Target Lesion A 47-year-old female with extensively metastatic TNBC involving the lung, liver, bone, and lymph nodes, initiated treatment with paxalisib (30 mg daily) in combination with pembrolizumab and gemcitabine/carboplatin in October 2025. Following three treatment cycles, imaging demonstrated a partial response, including complete resolution of a target lung lesion and the patient remains active on study. Patient 3 – Confirmed Complete Metabolic Response A 44-year-old female with metastatic TNBC who had previously received pembrolizumab/chemotherapy experienced disease progression involving bone and lung metastases in early 2025. Although ineligible for the formal trial due to prior pembrolizumab exposure, the patient was re-treated beginning in June 2025 with pembrolizumab/chemotherapy plus paxalisib (30 mg daily) under physician supervision. On November 10, 2025, FDG PET/CT imaging demonstrated no evidence of active malignancy, consistent with a complete metabolic response. This complete metabolic response was confirmed on follow-up imaging in January 2026, and the patient remains on paxalisib and pembrolizumab therapy. Paxalisib has been generally well tolerated in combination with pembrolizumab and chemotherapy. Approximately 75% of adverse events (AEs) were assessed as unlikely or unrelated to paxalisib. The paxalisib-related AEs were expected and predominantly mild to moderate, consistent with prior studies. At the 30 mg daily dose, one case of Grade 1 hyperglycemia has been observed, requiring no intervention. Two serious adverse events (SAEs) have been reported to date, both deemed unrelated to paxalisib. Following an initial targeted site activation phase designed to ensure rigorous protocol execution and informed by encouraging early clinical signals from the first patients treated, the Company expects to activate two additional clinical sites by April 2026, with two further sites planned for mid-2026. Kazia continues to anticipate the targeted enrollment of twelve TNBC pts target by the end of 2026 and topline data readout in early 2027 Kazia is also evaluating paxalisib in additional breast cancer populations, including earlier-stage TNBC and hormone receptor–positive, HER2-negative (HR+ / HER2-) breast cancer, where dysregulation of the PI3K/mTOR pathway is well established. Paxalisib's oral, once-daily administration offers a potentially convenient treatment option with minimal incremental burden to patients and clinical sites, an important consideration as the Company explores expansion into broader breast cancer populations. The Company will provide updates as these programs advance. "While these observations represent a preliminary read from ongoing studies, the consistency and depth of responses we are seeing including tumor regression across multiple metastatic sites and a complete metabolic response are highly encouraging," said Dr. John Friend, M.D., Chief Executive Officer of Kazia Therapeutics. "Confirmed complete responses in metastatic triple-negative breast cancer are exceedingly rare, particularly in patients who have already progressed on standard therapies. These early data reinforce our belief that paxalisib has the potential to meaningfully enhance the activity of existing immunotherapy-based regimens, and we look forward to generating additional clinical and translational insights throughout the year." For investor and media, please contact Mike Moyer, Managing Director LifeSci Advisors LLC, mmoyer@lifesciadvisors, +1-617-308-4306. About Kazia Therapeutics Kazia Therapeutics Limited (NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, an investigational brain penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat multiple forms of cancer. Licensed from Genentech in late 2016, paxalisib is or has been the subject of ten clinical trials in this disease. A completed Phase 2/3 study in glioblastoma (GBM-Agile) was reported in 2024, and discussions are ongoing for designing and executing a pivotal registrational study in pursuit of a standard approval. Other clinical trials involving paxalisib are ongoing in advanced breast cancer, brain metastases, diffuse midline gliomas, and primary central nervous system lymphoma, with several of these trials having reported encouraging interim data. Paxalisib was granted Orphan Drug Designation for glioblastoma by the U.S. Food and Drug Administration (FDA) in February 2018, and Fast Track Designation (FTD) for glioblastoma by the FDA in August 2020. Paxalisib was also granted FTD in July 2023 for the treatment of solid tumor brain metastases harboring PI3K pathway mutations in combination with radiation therapy. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid / rhabdoid tumors in June 2022 and July 2022, respectively. Kazia is also developing EVT801, a small molecule inhibitor of VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to be active against a broad range of tumor types and has provided evidence of synergy with immuno-oncology agents. In addition to its clinical-stage programs, Kazia is advancing NDL2, a potentially first-in-class nuclear PD-L1 protein degrader program targeting a newly identified mechanism of immunotherapy resistance and metastatic progression, currently in preclinical development. For more information, please visit or follow us on X @KaziaTx. Forward-Looking Statements This announcement may contain forward-looking statements, which can generally be identified as such by the use of words such as "may," "will," "estimate," "future," "forward," "anticipate," or other similar words. Any statement describing Kazia's future plans, strategies, intentions, expectations, objectives, goals or prospects, and other statements that are not historical facts, are also forward looking statements, including, but not limited to, the plan to activate additional clinical sites for the Phase 1b study in 2026, the anticipated completion of enrolment in the Phase 1b clinical trial in the fourth quarter of 2026, the anticipated topline data readout in early 2027, the potential of paxalisib's oral, once-daily administration to offer a convenient treatment option with minimal incremental burden to patients and clinical sites, the opportunities of evaluating paxalisib in additional breast cancer populations, and the potential benefits of paxalisib. Such statements are based on Kazia's current expectations and projections about future events and future trends affecting its business and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements, including risks and uncertainties associated with clinical and preclinical trials and product development, including the risk that interim or early data may not be consistent with final data, risks related to regulatory approvals, risks related to the impact of global economic conditions, and risks related to Kazia's ability to regain and/or maintain compliance with the applicable Nasdaq continued listing requirements and standards. These and other risks and uncertainties are described more fully in Kazia's Annual Report, filed on form 20-F with the SEC, and in subsequent filings with the United States Securities and Exchange Commission. Kazia undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this announcement. SOURCE Kazia Therapeutics Limited 21% more press release views with Request a Demo

临床结果孤儿药快速通道临床1期免疫疗法

2026-01-27

·CCMTV泌尿频道

ASCO GU 2026摘要标题发布：国际学术舞台再添中国声音，70余项研究入选

编者按 2026年美国临床肿瘤学会泌尿生殖系统肿瘤研讨会（ASCO GU 2026）将于当地时间2月26日至28日在美国旧金山举行。本次大会旨在呈现泌尿生殖系统肿瘤领域的最新科研突破与临床进展，并展望未来的治疗方向。近年来，中国在泌尿生殖系统肿瘤领域的研究持续深化，国际影响力不断提升。本届ASCO GU大会中，中国学者贡献显著，共有70余项研究入选（除括号标注2项口头报告外，其余均为壁报）。这些研究覆盖前列腺癌、肾细胞癌、尿路上皮癌等主要瘤种，涉及新药研发、联合治疗方案、精准预测模型、手术与放疗优化以及疾病机制探索等多个前沿方向，系统展现了中国团队在该领域的科研实力与临床创新。为清晰呈现中国研究的整体情况，下文对不同研究单位入选的研究信息进行汇总。若有任何遗漏，敬请读者留言指正。单位：四川大学华西医院（10项）摘要号：154 英文标题：Evaluation of PSA decline patterns in the Chinese subgroup of LIBERTAS, a phase 3 study of apalutamide plus continuous versus intermittent androgen deprivation therapy in metastatic castration-sensitive prostate cancer. 中文标题：LIBERTAS是一项3期研究，旨在评估阿帕他胺联合持续雄激素剥夺疗法对比间歇雄激素剥夺疗法治疗转移性去势敏感性前列腺癌的疗效，本研究评估了中国亚组的PSA下降模式作者：董强教授摘要号：213 英文标题：Real-world evaluation of olaparib combined with novel hormone therapy in metastatic castration-resistant prostate cancer with intraductal adenocarcinoma. 中文标题：在转移性去势抵抗性前列腺癌伴导管内腺癌中，奥拉帕利联合新型激素疗法的真实世界评价作者：qiyu zhu教授摘要号：264 英文标题：Aggressive-variant prostate cancer features and therapeutic outcomes in patients with de-novo metastatic hormone-sensitive prostate cancer 中文标题：侵袭性变异型前列腺癌的特征及新发转移性激素敏感性前列腺癌患者的治疗结局作者：qiyu zhu教授摘要号：366 英文标题：The therapeutic efficacy of radical prostatectomy and external beam radiation therapy in patients with histologic variants of prostate cancer. 中文标题：根治性前列腺切除术和体外放射治疗对组织学变异型前列腺癌患者的治疗效果作者：zehua tan教授摘要号：450 英文标题：Intratumoral mature TLSs to predict response to ICI rechallenge in non-clear cell renal cell carcinoma. 中文标题：肿瘤内成熟TLS预测非透明细胞肾细胞癌对ICI再次治疗的反应作者：yanfeng tang教授摘要号：506 英文标题：A prospective, multi-center, phase Ib/II trial of first-line cadonilimab plus axitinib in advanced non-clear cell renal cell carcinoma 中文标题：一项前瞻性、多中心、Ib/II期临床试验，分析了卡度尼利单抗联合阿昔替尼一线治疗晚期非透明细胞肾细胞癌的疗效作者：胡旭教授摘要号：701 英文标题：Predictive value of microsatellite instability/mismatch repair deficiency phenotype in upper tract urothelial carcinoma: A systematic review and meta-analysis. 中文标题：微卫星不稳定性/错配修复缺陷表型在上尿路尿路上皮癌中的预测价值：系统评价和荟萃分析作者：鲍一歌教授摘要号：774 英文标题：The efficacy and safety of distamab vedotin plus immunotherapy in locally advanced or metastatic urothelial carcinoma： A systematic review and meta-analysis. 中文标题：维迪西妥单抗联合免疫治疗局部晚期或转移性尿路上皮癌的疗效和安全性：系统评价和荟萃分析作者：鲍一歌教授摘要号：847 英文标题：Blood and urine liquid biopsy for molecular monitoring in HER2-positive muscle-invasive bladder cancer under bladder-preserving therapy 中文标题：在接受保膀胱治疗的HER2阳性肌层浸润性膀胱癌患者中，进行血液和尿液的液体分子监测作者：jiani deng教授摘要号：TPS905 英文标题：A phase II study evaluating the efficacy and safety of perioperative enfortumab vedotin plus toripalimab combined with endoscope-based kidney-sparing surgery for patients with high-risk upper tract urothelial carcinoma (WUTSUP-04-EV-JS001). 中文标题：一项评估围手术期维恩妥尤单抗联合特瑞普利单抗治疗高危上尿路尿路上皮癌患者保肾手术疗效和安全性的I期研究 (WUTSUP-04-EV-JS001) 作者：鲍一歌教授单位：复旦大学附属肿瘤医院（8项）摘要号：56 英文标题：Assistance of a large language model-based Al agent in preoperative communication for reduction of prostate cancer patients'anxiety and clinicians' burden： A prospective, randomized, single-blinded, phase Il trial. 中文标题：利用大型语言模型人工智能代理辅助的术前沟通，以减轻前列腺癌患者的焦虑和临床医生的负担：一项前瞻性、随机、单盲II期试验作者：zheng liu教授摘要号：150 英文标题：ARTEMIS-003：A phase 2 study of HS-20093 (GSK5764227)in patients with metastatic castration-resistant prostate cancer (mCRPC). 中文标题：ARTEMIS-003：一项针对转移性去势抵抗性前列腺癌(mCRPC)患者的HS-20093 (GSK5764227)的2期研究作者：卞晓洁教授摘要号：169 英文标题：A phase 1b/2 study to evaluate the safety and efficacy of igermetostat (XMW5004)in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer. 中文标题：一项1b/2期研究，旨在评估igermetostat (XMW5004)联合恩扎卢胺治疗转移性去势抵抗性前列腺癌患者的安全性和有效性作者：Yuan Chang教授摘要号：181 英文标题：The efficacy and safety of 177Lu-PSMA-617 in Chinese patients with post：-taxane metastatic castration-resistant prostate cancer： From a multicenter phase Il study. 中文标题：177Lu-PSMA-617治疗紫杉烷类药物治疗后转移性去势抵抗性前列腺癌的中国患者的疗效和安全性：一项多中心II期研究作者：叶定伟教授摘要号：234 英文标题：TRiIM28-mediated SUMOylation of ERG at K389 and its association with cell proliferation, PARP inhibitor response, and 53BP1 expression in castration-resistant prostate cancer. 中文标题：TRiIM28介导的ERG在K389位点的SUMO化及其与去势抵抗性前列腺癌细胞增殖、PARP抑制剂反应和53BP1表达的关系作者：shiwei liu教授摘要号：744 英文标题：Sacituzumab tirumotecan (Sac-TMT) plus pembrolizumab(Pembro) in participants (Pts) with advanced urothelial carcinoma (UC： Results from phase 2 2870-002/SKB264-ll-06 study. 中文标题：芦康沙妥珠单抗联合帕博利珠单抗治疗晚期尿路上皮癌患者：2870-002/SKB264-ll-06的2期研究结果作者：卞晓洁教授摘要号：762 英文标题：Intravesical T3011, an IL-12/anti-PD-1 armed oncolytic HSV-1,in BCG-naive high-risk NMIBC：A phase lla trial. 中文标题：膀胱内注射T3011（一种靶向IL-12/PD-1的溶瘤病毒HSV-1）治疗BCG初治高危 NMIBC：一项IIa期试验作者：叶定伟教授摘要号：764 英文标题：Phase 1/2 study of an anti-PD-L1/L-15 variant fusion protein (SIM0237)in BCG-unresponsive high-risk non-muscle-invasive bladder cancer(NMIBC). 中文标题：针对BCG无反应的高危非肌层浸润性膀胱癌(NMIBC)的抗PD-L1/L-15变体融合蛋白(SIM0237)的1/2期研究作者：叶定伟教授单位：中国医学科学院肿瘤医院（8项）摘要号：445 英文标题：Serum IgG：A novel biomarker for efficacy and prognosis in metastatic clear cellrenal cell carcinoma patients recelving first-line immunotherapy combined with tyrosine kinase inhibitors. 中文标题：血清IgG：一种用于评估接受一线免疫疗法联合酪氨酸激酶抑制剂治疗的转移性透明细胞肾细胞癌患者疗效和预后的新型生物标志物作者：韩天教授摘要号：499 英文标题：Interim analysis of vorolanib combined with cadonilimab in previously untreated patients with advanced renal cell carcinoma 中文标题：对既往未接受治疗的晚期肾细胞癌患者进行伏罗尼布联合卡度尼利单抗治疗的中期分析作者：yabo zhai教授摘要号：501 英文标题：Cadonilimab plus lenvatinib in advanced renal cell carcinoma： Interim analysis of a prospective, multi-cohort phase II study. 中文标题：卡度尼利单抗联合仑伐替尼治疗晚期肾细胞癌：一项前瞻性多队列阶段2期研究的中期分析作者：yabo zhai教授摘要号：563 英文标题：Prognostic value of baseline serum IgG in metastatic clear cell renal cell carcinoma treated with first-line I0-TKI therapy. 中文标题：基线血清IgG在接受一线IO-TKI治疗的转移性透明细胞肾细胞癌中的预后价值作者：hongwei wang教授摘要号：564 英文标题：Clinical significance of baseline serum IgG in metastatic renal cell carcinoma patients undergoing cytoreductive nephrectomy 中文标题：基线血清IgG在接受细胞减灭性肾切除术的转移性肾细胞癌患者中的临床意义作者：hongwei wang教授摘要号：677 英文标题：From bladder to upper urinary tract： Unveiling the epidemiological dynamics of urothelial carcinoma 中文标题：从膀胱到上尿路：揭示尿路上皮癌的流行病学动态作者：杜淦教授摘要号：742 英文标题：Clinical outcomes of neoadjuvant chemotherapy-guided bladder preservation in muscle-invasive bladder cancer. Long-term results of a phase Il trial. 中文标题：新辅助化疗指导下膀胱保留治疗肌层浸润性膀胱癌的临床疗效：一项II期试验的长期结果作者：杜淦教授摘要号：775 英文标题：Neoadjuvant combined chemotherapy and immunotherapy for upper tract urothelial carcinoma，Final results from a phase II study. 中文标题：化疗联合免疫新辅助治疗上尿路尿路上皮癌的2期研究最终结果作者：毕新刚教授单位：天津医科大学第二医院（6项）摘要号：765 英文标题：Neoadjuvant tislelizumab in combination with disitamab vedotin (RC48) followed by distal ureterectomy for patients with HER-2 expressing lower segment ureteral carcinoma (LSUC)： A single-arm, phase Il, single-center study. 中文标题：新辅助替雷珠单抗联合维迪西妥单抗治疗HER-2表达的下段输尿管癌（LSUC）患者，随后行远端输尿管切除术：一项单臂II期单中心研究作者：houyuan chen教授摘要号：767 英文标题：Association of renal function in non-hydronephrotic patients receiving PD-1 ICIs for bladder cancer with treatment response. 中文标题：非肾积水患者接受PD-1单抗免疫治疗膀胱癌时肾功能与治疗反应的关系作者：chong shen教授摘要号：768 英文标题：Fixed low-dose nab-paclitaxel with tislelizumab in non-metastatic bladder cancer. A post-hoc analysis of dose expose in TRUCE-01 and TRUCE-02 trials. 中文标题：在非转移性膀胱癌中，固定低剂量白蛋白紫杉醇联合替雷利珠单抗的疗效：TRUCE-01和TRUCE-02试验的剂量暴露事后分析作者：hailong hu教授摘要号：804 英文标题：Low-coverage whole-genome sequencing of urinary tumor DNA to characterize genomic correlates of lymphovascular invasion in bladdercancer. 中文标题：对尿液肿瘤DNA进行低覆盖度全基因组测序，以表征膀胱癌淋巴血管侵犯的基因组相关性作者：zihan xue教授摘要号：TPS910 英文标题：Randomized trial of urinary tumor DNA (utDNA) testing-guided repeat transurethral resection (re-TURBT) in non-muscle-invasive bladder cancer (NMIBC)：TRUCE-LB01. 中文标题：尿液肿瘤DNA检测指导下二次经尿道切除术(re-TURBT)治疗非肌层浸润性膀胱癌的随机试验：TRUCE-LB01 作者：hailong hu教授摘要号：TPS911 英文标题：Randomized trial of urinary tumor DNA (utDNA) testing-guided cystoscopy in high-risk/very high-risk non-muscle-invasive bladder cancer (NMIBC)： TRUCE-LB02. 中文标题：尿液肿瘤DNA检测引导膀胱镜检查在高危/极高危非肌层浸润性膀胱癌中的随机试验：TRUCE-LB02 作者：hailong hu教授单位：北京大学第一医院（4项）摘要号：494 英文标题：Phase 2 trial of belzutifan in participants from China and Japan with von Hippel-Lindau disease-associated tumors: Results from LITESPARK-015 cohort B1. 中文标题：贝组替凡在中国和日本患有von Hippel-Lindau病相关肿瘤的参与者中开展的2期试验：LITESPARK-015队列B1的结果作者：龚侃教授摘要号：497 英文标题：Fruquintinib combined with everolimus in Chinese patients with advanced/metastatic dlear cel renal cell carcinoma (ccRCC) after progression on immune checkpoint inhibitors (ICIs)： Results from a phase II single arm clinical trial. 中文标题：呋喹替尼联合依维莫司治疗免疫检查点抑制剂（ICIs）治疗进展后的中国晚期/转移性肾细胞癌（ccRCC）患者：一项II期单臂临床试验的结果作者：杨恺惟教授摘要号：691 英文标题：Distamab vedotin plus PD-1 inhibitors as neoadjuvant therapy for cisplatin-ineligible muscle-invasive bladder cancer： A real-world retrospectivestudy. 中文标题：维迪西妥单抗联合PD-1抑制剂作为不适合顺铂治疗的肌层浸润性膀胱癌的新辅助治疗：一项真实世界的回顾性研究作者：xinjia ding教授摘要号：788 英文标题：Effect of programmed cell death protein ligand1 nuclear translocation mediated by Enolase on urothelial carcinoma immune evasion 中文标题：烯醇化酶介导的程序性细胞死亡蛋白配体1核转位对尿路上皮癌免疫逃逸的影响作者：honggang ying教授单位：上海交通大学医学院附属仁济医院（4项）摘要号：422（口头报告）英文标题：Fruquintinib plus serplulimab as first-line therapy in metastatic or unresectable non-clear cell renal cell carcinoma (nccRCC)： Updated efficacy and safety data from a multicenter, single-arm, phase Il trial. 中文标题：呋喹替尼联合斯鲁利单抗作为转移性或不可切除的非透明细胞肾细胞癌(nccRCC)的一线治疗：来自多中心、单臂II期试验的最新疗效和安全性数据讲者：黄吉炜教授摘要号：846 英文标题：Blood- and urine-based ctDNA profiling and monitoring in bladder carcinoma in situ. 中文标题：基于血液和尿液的ctDNA分析和膀胱原位癌监测作者：张瑞赟教授摘要号：848 英文标题：Real-world urinary detection of FGFR alterations to guide FGFR inhibitor therapy in bladder cancer. 中文标题：利用真实世界的尿液检测FGFR改变来指导膀胱癌的FGFR抑制剂治疗作者：jingyu zang教授摘要号：849 英文标题：Liquid biopsy guided disitamab vedotin combined with toripalimab and radiotherapy for multimodal organ-sparing treatment of muscle invasive bladder cancer (DECIDING study). 中文标题：液体活检指导的维迪西妥单抗联合特瑞普利单抗和放射疗法用于肌层浸润性膀胱癌的多模式器官保留治疗（DECIDING研究）作者：张瑞赟教授单位：山东大学齐鲁医院（4项）摘要号：644 英文标题：Prospective multicenter development and external validation of a narrow-band imaging based prediction model for malignancy risk in bladder lesions. 中文标题：前瞻性多中心开发和外部验证基于窄带成像的膀胱病变恶性风险预测模型作者：hao liang教授摘要号：657 英文标题：Demographic and socioeconomic disparities in early-onset vs. late-onset bladder cancer. A cross-sectional study in the NIH All of Us research program. 中文标题：早发型膀胱癌与晚发型膀胱癌在人口统计学和社会经济方面的差异，一项来自美国国立卫生研究院All of Us研究项目的横断面研究作者：shijie zhang教授摘要号：856 英文标题：Multi-omic remodeling of urine-exposed ileal mucosa after ileocystoplasty. 中文标题：回肠膀胱成形术后尿液暴露的回肠黏膜的多组学重塑作者：peixin li教授摘要号：857 英文标题：Preoperative CT radiomics-deep learning signature for Lymphovascular invasion in bladder cancer: External validation and clinical utility 中文标题：膀胱癌淋巴血管侵犯的术前CT放射组学-深度学习特征：外部验证和临床应用作者：yihao zhao教授单位：中山大学肿瘤防治中心（4项）摘要号：1 英文标题：Comparative outcomes of radiotherapy and interventional therapy for adrenal oligo metastases： A multicenter retrospective study. 中文标题：肾上腺寡转移瘤放射治疗与介入治疗的比较结局：一项多中心回顾性研究作者：yanke zhang教授摘要号：426 英文标题：The application of 5.0-Tesla non-enhanced MRl in the preoperative assessment of renal tumors. 中文标题：5.0特斯拉非增强磁共振成像在肾肿瘤术前评估中的应用作者：xianda chen教授摘要号：472 英文标题：Clinical outcomes of retroperitoneal lymph node dissection in patients with cT3-4N,Monon-clear cell renal cell carcinoma. 中文标题：cT3-4N、单透明细胞肾细胞癌患者行腹膜后淋巴结清扫术的临床结局作者：xianda chen教授摘要号：TPS576 英文标题：Systemic therapy combined with radiotherapy versus systemic therapy alone for oligometastatic kidney cancer (STRoKER)：A multicenter,randomized controlled phase Ill trial. 中文标题：全身治疗联合放射治疗对比单纯全身治疗寡转移性肾癌（STRoKER）：一项多中心、随机对照III期试验作者：qiwen pan教授单位：北京大学肿瘤医院（3项）摘要号：766 英文标题：Neoadjuvant treatment with disitamab vedotin plus perioperative toripalimab in patients with HER2-expressing muscle-invasive bladder cancer(MIBC)in the phase Il RC48-C017 trial： Updated results. 中文标题：在II期RC48-C017试验中，对HER2表达的肌层浸润性膀胱癌(MIBC)患者，进行新辅助维迪西妥单抗联合围手术期特瑞普利单抗治疗：最新结果作者：盛锡楠教授摘要号：782 英文标题：Preliminary results from phase II enfortumab vedotin plus toripalimab compared to gemoitabine-cisplatin as neoadjuvant therapy for patients with muscle-invasive bladder cancer (MlBC). 中文标题：维恩妥尤单抗联合特瑞普利单抗对比吉西他滨-顺铂作为肌层浸润性膀胱癌 (MlBC) 患者的新辅助治疗方案的2期初步结果作者：周莉教授摘要号：817 英文标题：Toripalimab in patients with previously treated advanced upper tract urothelial carcinoma A subgroup analysIs of the phase I POLARIS-.3 trial. 中文标题：特瑞普利单抗用于既往接受过治疗的晚期上尿路尿路上皮癌患者作者：jinchang wei教授单位：南京鼓楼医院（3项）摘要号：375 英文标题：MRI-targeted biopsy with index lesion ipsilateral or bilateral systematic biopsy in prostate cancer： A multicente, paired, noninferiority, observational trial. 中文标题：前列腺癌的MRI靶向活检联合同侧或双侧系统性活检：一项多中心、配对、非劣效性、观察性试验作者：程勇兵教授摘要号：702 英文标题：Oncological outcomes and HER2 expression of urothelial carcinoma with squamous differentiation： A retrospective study. 中文标题：尿路上皮癌鳞状分化患者的肿瘤学结局和HER2表达：一项回顾性研究作者：xin wang教授摘要号：835 英文标题：The molecular mechanism of ymph node metastasis driven by B Iymphocyte FOXO1 palmitoylation induced by ACSL5 deficiency in bladder cancer cells. 中文标题：膀胱癌细胞中ACSL5缺陷诱导的B淋巴细胞FOXO1棕榈酰化驱动淋巴结转移的分子机制作者：yifan sun教授单位：南方医科大学南方医院（3项）摘要号：374 英文标题：Role of urinary exosomal FAM153C-RPL19in detection and risk stratification of prostate cancer：A multicentre Chinese cohort study. 中文标题：尿液外泌体FAM153C-RPL19在前列腺癌检测和风险分层中的作用：一项中国多中心队列研究作者：bisheng cheng教授摘要号：521 英文标题：Association of prior 5-a-reductase inhibitor exposure with I CI benefit in metastatic RCC，Multicenter cohort with single-cell immune profiling. 中文标题：既往5α-还原酶抑制剂暴露与转移性肾细胞癌患者ICI获益的相关性，多中心队列研究及单细胞免疫分析作者：bisheng cheng教授摘要号：792 英文标题：Inhibiting a2,6-sialylation and its association with nectin-4 stability and macropinocytic uptake in bladder cancer. 中文标题：抑制α2,6-唾液酸化及其与膀胱癌中nectin-4稳定性和巨胞饮摄取的关系作者：bisheng cheng教授单位：上海市第十人民医院（3项）摘要号：114 英文标题：Comparison of quantitative functional RAD51 foci and genomic prediction PARPi response in mCRPC: A multicenter real-world study. 中文标题：定量功能性RAD51定位对比基因组预测PARPi在mCRPC中的反应：一项多中心真实世界研究作者：杨斌教授摘要号：190 英文标题：Long-term clinical outcomes and genomic predictors of PSMA-PET/CT-guided cytoreductive progression-directed therapy in patients with oligo progressive castration-resistant prostate cancer. 中文标题：PSMA-PET/CT指导的细胞减灭进展导向治疗在寡进展去势抵抗性前列腺癌患者中的长期临床结局和基因组预测因子作者：杨斌教授摘要号：236 英文标题：Heterogeneity and synergistic inhibition of the poly(ADP-ribose) polymerase and androgen receptor signaling pathway in patients with metastatic castration-resistant prostate cancer. 中文标题：转移性去势抵抗性前列腺癌患者中聚（ADP-核糖）聚合酶和雄激素受体信号通路的异质性和协同抑制作者：杨斌教授单位：国内其他医疗机构入选的研究摘要号：无（大会发言）英文标题：Optimizing Surgical Management of Non-Muscle-Invasive Bladder Cancer 中文标题：优化非肌层浸润性膀胱癌的手术治疗讲者：张源津（Jeremy Y.C. Teoh）教授单位：中国香港中文大学摘要号：96 英文标题：Quantifying the hidden burden of metastatic prostate cancer. 中文标题：量化转移性前列腺癌的隐性负担作者：Bo-Sheng Wu教授单位：中国台湾双和医院摘要号：130 英文标题：A prospective, randomized, cross-overtrial to assess patient preference for goserelin microsphere versus goserelin implant in prostate cancer：Interim results of the GOMIMP study. 中文标题：一项前瞻性、随机、交叉试验，旨在评估前列腺癌患者对戈舍瑞林微球或戈舍瑞林植入剂的偏好：GOMIMP研究的中期结果作者：王雪刚教授单位：厦门大学附属第一医院摘要号：172 英文标题：Phase 1 safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of pasritamig in Asian population with metastatic castration resistant prostate cancer (mCRPC). 中文标题：pasritamig在亚洲转移性去势患者中的1期安全性、有效性、药代动力学和药效学研究作者：戴君勇教授单位：重庆大学附属肿瘤医院摘要号：191 英文标题：Efficacy of rezvilutamide in preventing the flare phenomenon induced by GnRH agonists in newly diagnosed metastatic hormone-sensitive prostate cancer： An exploratory multicenter randomized controlled trial. 中文标题：瑞维鲁胺预防新诊断的转移性激素敏感性前列腺癌中GnRH激动剂引起的闪烁现象的效果：一项探索性多中心随机对照试验作者：杨春光教授单位：华中科技大学同济医学院附属同济医院摘要号：193 英文标题：Redefining multimodal treatment in high-volume metastatic hormone-sensitive prostate cancer： Prospective evidence for robot-assisted cytoreductive prostatectomy following triplet systemic therapy. 中文标题：重新定义高容量转移性激素敏感性前列腺癌的多模式治疗：机器人辅助细胞减灭性前列腺切除术在三联全身治疗后的前瞻性证据作者：shangqian wang教授单位：南京医科大学第一附属医院摘要号：245 英文标题：Multi-omics profiling of residual cancer burden after neoadjuvant hormonal therapy guides subtype-directed treatment in high-risk and locally advanced prostate cancer. 中文标题：新辅助激素治疗后残余癌症负荷的多组学分析可指导高危和局部晚期前列腺癌亚型定向治疗作者：蔡燚教授单位：中南大学湘雅医院摘要号：495 英文标题：Efficacy of selective renal tumor embolization combined with axitinib and reduced-dose toripalimab in oligometastatic clear cel renal carcinoma： An updated analysis with patient-derived organoid and immune co-culture insights. 中文标题：选择性肾肿瘤栓塞联合阿昔替尼和减量特瑞普利单抗治疗寡转移性透明细胞肾癌的疗效：基于患者来源的类器官和免疫共培养的最新分析作者：杜君教授单位：天津医科大学肿瘤医院摘要号：772 英文标题：Efficacy and safety of disitamab vedotin combined with intravesical electromotive mitomycin-C in patients with HER2-expressing high-risk non-muscle-invasive bladder cancer： A phase Il study. 中文标题：维迪西妥单抗联合膀胱内电化学灌注丝裂霉素C治疗HER2表达高危非肌层浸润性膀胱癌患者的疗效和安全性：一项II期研究作者：xuebing han教授单位：山西省肿瘤医院摘要号：783 英文标题：Three-year median follow-up update of BGB-A317-2002-HT： A phase 2 study of neoadjuvant tislelizumab plus gemcitabine and cisplatin in patients with cT2-T4aN0M0 muscle-invasive bladder cancer. 中文标题：BGB-A317-2002-HT的三年中位随访更新：一项针对cT2-T4aN0M0肌层浸润性膀胱癌患者的新辅助替雷利珠单抗联合吉西他滨和顺铂的2期研究作者：李锴文教授单位：中山大学孙逸仙纪念医院摘要号：811 英文标题：Effect of tumor methionine metabolism via MAT2A on CD8+ T-cell exhaustion through SAM-CHOP axis in bladder cancer 中文标题：肿瘤甲硫氨酸代谢通过MAT2A对膀胱癌中CD8+ T细胞耗竭的SAM-CHOP轴的影响作者：zhe zhang教授单位：中国医科大学附属第一医院摘要号：TBS887 英文标题：Selective bladder preservation after neoadjuvant zanidatamab combined with tislelizumab and chemotherapy in patients with HER2-positive muscle-invasive bladder cancer (HARBOR)： A multicenter study. 中文标题：新辅助zanidatamab联合替雷丽珠单抗和化疗方案治疗HER2阳性肌层浸润性膀胱癌患者后选择性保留膀胱（HARBOR）：一项多中心研究作者：yiming su教授单位：福建医科大学附属协和医院摘要号：TBS899 英文标题：EMPOWERO1： A phase ll study of zanidatamab combined with bacillus Calmette-Guerin (BCG) in HER2-positive high-risk non-muscle-invasive bladder cancer (HR NMIBC). 中文标题：EMPOWERO1：一项针对HER2阳性高危非肌层浸润性膀胱癌(HR NMIBC)的II期研究，评估zanidatamab与卡介苗联合治疗的疗效作者：王宗任教授单位：中山大学附属第一医院整理内容来自：截止2026年1月27日的ASCO-GU 2026官网更新内容。本平台致力于为医疗卫生专业人士提供丰富的医学信息。请注意，本平台发布的内容不能替代专业的医疗建议，也不应被用作诊疗指导。如果将这些信息用于非医学信息了解的目的，本平台不承担相关责任。此外，本平台对发布的内容并不代表赞同其描述和观点。如有涉及版权问题，请权利人与我们联系，我们将尽快处理。 — END — CCMTV临床频道注册会员数据突破210万+，平均每日更新视频及资讯内容300余条，目前拥有医学视频数量10万+，累积时长达185万+分钟，致力于打造贯穿医学教育全过程的专业服务平台。CCMTV药械营销推广覆盖开发期（上市前）、导入期（上市）、成长期、成熟期、衰退期。通过CCMTV朱雀AI大模型，实现权威精准触达和智能反馈分析，助力药械推广进入数字化闭环营销时代。

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·良医汇乳腺肿瘤资讯

【1112】2025 SABCS深度报道 | 告别“负面”标签，以生物学分层解锁三阴性乳腺癌精准治疗新图景

编译：肿瘤资讯来源：SABCS官网三阴性乳腺癌（TNBC）因具有高度异质性且缺乏明确治疗靶点，长期以来是临床管理的难点。在2025年圣安东尼奥乳腺癌研讨会（SABCS）上，“如何治疗三阴性乳腺癌——三阴性不再消极（How to Treat TNBC—Triple-Negative Not so Negative Anymore）”教育专场整合最新循证医学证据，向学界传递出明确信号：TNBC的治疗逻辑正发生根本性转变。本次专场由Marlene Kok教授主持，汇聚了早期、局部晚期及转移性乳腺癌领域的权威专家与患者权益代表，旨在为临床医生提供一份更新的TNBC全病程管理指引。 I期TNBC的治疗决策 I期TNBC（肿瘤≤2cm，无淋巴结转移）的治疗决策始终是临床争议焦点。Elie Rassy教授通过详实的数据分析，探讨了如何在保障疗效的前提下，规避过度治疗带来的长期毒性。 1. 辅助化疗的分层标准尽管指南通常建议TNBC患者接受化疗，但Rassy教授指出，并非所有I期患者均可从中获益。通过回顾美国监测、流行病学与最终结果（SEER）数据库（n=8601）及多项回顾性研究，他提出了更精细的分层建议： T1a N0（肿瘤＜5mm）：此类患者预后极佳，化疗并未显著降低复发风险，因此通常不推荐辅助化疗； T1c N0（肿瘤＞10mm）：这是明确的化疗指征区间。依据美国临床肿瘤学会（ASCO）和欧洲肿瘤内科学会（ESMO）指南，此类患者以辅助化疗为标准治疗；对于存在高危因素（如Ki-67高表达、脉管侵犯、肿瘤贴近切缘需保乳）的人群，可考虑新辅助治疗以优化手术策略； T1b N0（肿瘤5-10mm）：这是临床决策的难点。数据显示，化疗虽能降低该亚群患者的复发风险，但绝对获益有限。Rassy教授建议将肿瘤5mm作为考虑化疗的起始值，并结合患者年龄、身体状态实施个体化治疗决策。 2. 蒽环类药物的去留下一个问题是，确定需化疗后，是否必须包含蒽环类药物？Rassy教授引用丹麦乳腺癌协作组（DBCG）07-READ研究、PlanB研究等关键数据指出，在I期TNBC患者中，无蒽环方案（如TC方案：多西他赛+环磷酰胺，6周期）的10年无病生存期（DFS）和总生存期（OS），与含蒽环方案（如EC-T方案）相比无统计学差异。因此，对于心脏毒性风险较高或希望降低治疗毒性的I期TNBC患者，去蒽环方案已成为循证医学支持的标准选择。 3. TILs：超越解剖分期的预后指标肿瘤浸润淋巴细胞（TILs）不仅是免疫微环境的反映，更是极强的预后保护因素。Rassy教授展示了多中心汇总分析的数据：未接受化疗的I期TNBC患者中，TILs水平每增加10%，侵袭性疾病复发或死亡风险降低约14%；当TILs≥30%时，患者预后显著改善；而TILs≥50%时，患者5年总生存率可达95%以上，且该获益独立于化疗。这些数据提示，高TILs水平的I期TNBC患者未来或可完全豁免化疗。目前，ETNA、OPTImaL等前瞻性临床试验正基于此逻辑，旨在验证基于TILs豁免化疗的可行性，有望改写未来的诊疗指南。 II/III期TNBC的强化治疗对于复发风险较高的II/III期TNBC，治疗目标明确指向病理学完全缓解（pCR）——这是患者长期生存的替代终点。Gustavo Werutsky教授详细梳理了此类人群的新辅助治疗的现状及未来方向。 1. KEYNOTE-522：“欲戴王冠，必承其重” 目前，高危早期TNBC的标准治疗已确立为“帕博利珠单抗+化疗（含卡铂）”新辅助方案（KEYNOTE-522模式）。该方案将pCR率提升至64.8%，并显著改善无事件生存期（EFS）。然而，Werutsky教授强调，临床医生必须正视其伴随的挑战：免疫相关不良事件（irAEs）：约14.9%的患者会出现3级及以上irAEs，甲状腺功能异常、肾上腺功能不全等内分泌毒性往往需要终身治疗；真实世界数据与临床试验的差距：真实世界研究显示，受剂量强度调整、不良反应管理等因素影响，实际pCR率略低于临床试验数据，且停药率更高； 2. 针对Non-pCR患者的治疗升级新辅助治疗后仍有残留病灶（Non-pCR）的TNBC患者预后较差，目前的标准辅助治疗包括卡培他滨（CREATE-X研究）或奥拉帕利（OlympiA研究，针对gBRCA突变患者）。 Werutsky教授指出，未来的发展趋势是将抗体药物偶联物（ADC）前移至新辅助阶段。例如，TROPION-Breast04研究正探索Dato-DXd联合免疫治疗在新辅助阶段的应用，试图替代传统化疗，以期在降低治疗毒性的同时提高pCR率，从源头改善高危患者的预后。 3. ctDNA：指导治疗调整的动态标尺如何更早识别高危患者？Werutsky教授重点介绍了循环肿瘤DNA（ctDNA）的应用前景：新辅助阶段：ctDNA的早期清除与pCR高度相关，可作为早期疗效的预测指标；辅助阶段：ctDNA阳性是复发的预测因子之一，通常早于影像学检查发现复发迹象。未来的治疗模式或将基于ctDNA状态进行动态调整——例如ZEST试验对术后ctDNA阳性患者使用PARP抑制剂进行干预。这种以微小残留病灶（MRD）为驱动的治疗策略，将比传统解剖学分期更为精准。晚期TNBC的治疗格局晚期TNBC的治疗已发生颠覆性变化。Sara Tolaney教授通过梳理一线及后线治疗的最新数据，描绘了以ADC药物为核心的治疗图谱。 1. 一线治疗：免疫联合与ADC的博弈 PD-L1阳性（CPS≥10）：目前的标准方案为化疗联合帕博利珠单抗（KEYNOTE-355研究）。但最新的ASCENT-04研究显示，戈沙妥珠单抗（SG）联合帕博利珠单抗相比化疗联合免疫治疗，显著延长了无进展生存期（PFS，HR 0.65），且总生存期（OS）呈现获益趋势。这一组合有望成为PD-L1阳性晚期TNBC患者新的优选方案； PD-L1阴性：这是传统化疗疗效最差的人群。ASCENT-03（SG）和TROPION-Breast02（Dato-DXd）两项研究均证实，ADC药物在一线治疗中显著优于传统化疗。药物选择策略：Tolaney教授建议根据毒性谱选择药物。SG的主要毒性为中性粒细胞减少和腹泻，Dato-DXd则需重点关注口腔炎和干眼症；此外，Dato-DXd在早期复发（＜6个月）人群中拥有更具体的数据支持。 2. 特殊人群：gBRCA突变患者的排兵布阵对于携带gBRCA突变的晚期TNBC患者，治疗选择需综合考量PD-L1状态： PD-L1阴性：鉴于PARP抑制剂的生活质量获益优于化疗和ADC，且一线应用时PFS获益更显著，建议优先使用PARP抑制剂； PD-L1阳性：鉴于免疫治疗在后线应用时疗效大幅下降，建议一线优先使用含免疫方案（如免疫+化疗或免疫+ADC），将PARP抑制剂留作后线治疗。 3. 后线治疗困境与ADC序贯使用随着ADC药物前移至一线治疗，二线及后线治疗面临新的挑战。Tolaney教授指出，ADC治疗进展后转回传统化疗的疗效极差（PFS仅约2~3个月）。目前的探索方向是ADC的序贯使用（如SG进展后使用T-DXd）。尽管拓扑异构酶载体交叉耐药等机制导致疗效有所降低，但真实世界数据显示，其PFS仍优于化疗。此外，针对HER2超低表达（Ultra-low）人群的T-DXd应用、靶向B7H4等新靶点的ADC药物研发，是解决后线耐药问题的关键突破口。患者视角的治疗考量会议最后，一位晚期TNBC长期幸存者Janice Cowden女士结合患者分享了自己就诊多年的真实体验。作为患者权益代表，Cowden女士指出临床研究在追求疗效数据的同时，须关注患者的实际生存质量。 1. 真实世界中的ADC毒性负担 Cowden女士分享了一项由患者组织发起的ADC药物体验调查（PCDI）结果：超过80%的患者经历了严重影响日常生活的副作用，其中使用SG的患者中约42%需要下调剂量。这提示临床试验中报告的不良反应数据可能低估了患者在真实生活中的困扰。 “最大耐受剂量”与“患者中心剂量” 她提出了一个引人深思的观点：肿瘤学传统剂量设定多基于最大耐受剂量，但晚期乳腺癌需长期维持治疗，属于慢病管理模式；许多患者通过主动调整剂量，反而获得了更长的治疗持续时间和更好的生活质量。因此，Cowden女士呼吁临床医生制定治疗方案时，应结合患者的耐受性和生活诉求灵活调整剂量，避免因治疗毒性过高导致患者过早终止有效治疗。总结 2025年SABCS的这场TNBC专场会议，清晰勾勒出该领域从“解剖学分期”向“生物学分层”演进的轨迹：在早期TNBC领域，利用TILs等生物标志物筛选低危人群，推行化疗降阶梯策略；在高危局部晚期TNBC领域，通过新辅助免疫联合治疗及潜在的ADC前移应用，最大化pCR获益；在晚期TNBC领域，ADC药物已全面重塑一线及后线治疗格局，即便是PD-L1阴性患者也迎来了强效治疗选择。未来的挑战将集中在两方面：一是如何利用ctDNA等工具实现动态精准监控；二是如何在患者生存时间不断延长的背景下，通过剂量优化以提升患者的生活质量。责任编辑：肿瘤资讯-Ethon 排版编辑：肿瘤资讯-slb 版权声明本文专供医学专业人士参考，未经著作人许可，不可出版发行。同时，欢迎个人转发分享，其他任何媒体、网站如需转载或引用本网版权所有内容，须获得授权，且在醒目位置处注明"转自：良医汇-肿瘤医生APP"。

ASCO会议临床1期临床结果临床2期

100 项与奥拉帕利相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09730	奥拉帕利	L01XX46	DB09074

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
晚期子宫内膜癌	欧盟	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	冰岛	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	列支敦士登	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	挪威	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	欧盟	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	冰岛	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	列支敦士登	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	挪威	AstraZeneca AB	2024-08-15
BRCA突变阳性乳腺癌	日本	AstraZeneca KK	2022-08-24
HRD 阳性卵巢癌	美国	AstraZeneca Pharmaceuticals LP	2020-05-19
HRR 基因突变去势抵抗性前列腺癌	美国	AstraZeneca Pharmaceuticals LP	2020-05-19
胰腺癌	韩国	AstraZeneca Pharmaceuticals LP	2019-10-29
前列腺癌	韩国	AstraZeneca Pharmaceuticals LP	2019-10-29
铂敏感性卵巢癌	中国	AstraZeneca AB	2018-08-22
复发性HER2阴性乳腺癌	日本	MSD KK (Tokyo)	2018-07-02
复发性HER2阴性乳腺癌	日本	AstraZeneca KK	2018-07-02
转移性胰腺腺癌	澳大利亚	AstraZeneca Pty Ltd.	2018-05-23
乳腺癌	加拿大	AstraZeneca Canada, Inc.	2016-04-29
卵巢癌	加拿大	AstraZeneca Canada, Inc.	2016-04-29
BRCA突变去势抵抗性前列腺癌	欧盟	AstraZeneca AB	2014-12-16

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
去势抵抗性前列腺癌	申请上市	美国	AstraZeneca PLC	2022-08-17
子宫内膜癌	临床3期	法国	AstraZeneca PLC	2024-06-26
子宫内膜样癌	临床3期	法国	AstraZeneca PLC	2024-06-26
卵巢浆液性腺癌	临床3期	美国	Novartis Pharmaceuticals Corp.	2021-07-22
卵巢浆液性腺癌	临床3期	中国	Novartis Pharmaceuticals Corp.	2021-07-22
卵巢浆液性腺癌	临床3期	阿根廷	Novartis Pharmaceuticals Corp.	2021-07-22
卵巢浆液性腺癌	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2021-07-22
卵巢浆液性腺癌	临床3期	奥地利	Novartis Pharmaceuticals Corp.	2021-07-22
卵巢浆液性腺癌	临床3期	比利时	Novartis Pharmaceuticals Corp.	2021-07-22
卵巢浆液性腺癌	临床3期	巴西	Novartis Pharmaceuticals Corp.	2021-07-22

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分期

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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


NCT02693535 (TAPUR, Pubmed \| JCO Precis Oncol)	临床2期	实体瘤 ATM Alterations	116	Olaparib (colorectal cancer)	願鏇夢餘窪齋窪襯夢顧(構獵廠衊構糧鹹繭獵廠) = 壓糧齋遞鏇製憲壓製遞築夢繭膚獵鬱夢鹽壓壓 (糧製廠鹽餘鹽襯夢繭鹹, 8 ~ 100) 更多	积极	2026-01-01
				Olaparib (lung cancer)	願鏇夢餘窪齋窪襯夢顧(構獵廠衊構糧鹹繭獵廠) = 醖遞顧網鏇繭願鹽艱齋築夢繭膚獵鬱夢鹽壓壓 (糧製廠鹽餘鹽襯夢繭鹹, 32 ~ 100)
NCT04269200 (DUO-E \| GOG-3041 \| ENGOT-EN10 \| DUO-E/GOG-3041/ENGOT-EN10, CTgov)	临床3期	复发性子宫内膜癌	805	placebo+olaparib+carboplatin+paclitaxel+durvalumab (Global Cohort - SoC)	範範遞鏇憲鹽獵艱鑰艱(廠選蓋觸窪範築壓願網) = 衊製襯鏇選鏇淵廠齋艱鏇構蓋製壓壓構願選遞 (積壓壓衊觸鹽製壓廠網, 淵憲築鏇獵獵簾齋憲鬱 ~ 獵築願簾壓觸餘構鹽憲) 更多	-	2025-12-23
				Durvalumab (Global Cohort - SoC + Durvalumab)	範範遞鏇憲鹽獵艱鑰艱(廠選蓋觸窪範築壓願網) = 餘獵衊構鏇醖遞鹹鹹鹽鏇構蓋製壓壓構願選遞 (積壓壓衊觸鹽製壓廠網, 鬱憲觸顧廠壓襯鑰廠廠 ~ 築衊網網築壓鹹壓夢構) 更多
NCT05457257 (CTgov)	临床4期	转移性去势抵抗性前列腺癌	43	Olaparib (Olaparib 300 mg bd)	襯襯艱構衊鑰鹽膚網淵(餘遞艱膚顧膚積構糧願) = 構製齋蓋糧鹹膚蓋積憲蓋積構淵淵顧淵願願壓 (築憲選鏇窪觸壓廠鑰夢, 夢壓獵網壓鏇構憲繭艱 ~ 餘範齋顧鬱構憲艱鬱製) 更多	-	2025-12-19
				enzalutamide+prednisone+abiraterone acetate (Investigators Choice of NHA)	襯襯艱構衊鑰鹽膚網淵(餘遞艱膚顧膚積構糧願) = 醖網繭衊鬱築鹽糧齋蓋蓋積構淵淵顧淵願願壓 (築憲選鏇窪觸壓廠鑰夢, 壓醖齋積鏇顧壓鏇獵觸 ~ 壓廠鹽衊築製窪醖選願) 更多
NCT03594396 (MEDIOLA, SABCS2025)	临床2期	ER低表达乳腺癌新辅助 ER-low	54	Olaparib 300mg bid + Durvalumab 1500 mg	醖糧窪夢醖餘鏇廠遞簾(製襯鑰鹹蓋糧衊衊鑰憲) = 齋醖築餘襯選觸積醖願鹹膚獵鹽願醖餘鹹憲遞 (獵構範選簾窪醖夢醖鹽 ) 更多	积极	2025-12-11
SABCS2025	N/A	三阴性乳腺癌辅助 BRCA1 mutations	709	Pembrolizumab	衊壓願齋壓繭鏇鹽構製(選艱願積鏇窪蓋築獵鑰) = 構觸壓廠獵網構壓齋艱選鹹觸願糧簾鬱繭選觸 (鹹觸夢艱繭觸鹽鬱餘積 ) 更多	积极	2025-12-11
				Capecitabine	衊壓願齋壓繭鏇鹽構製(選艱願積鏇窪蓋築獵鑰) = 齋遞夢築蓋簾廠網鹹鑰選鹹觸願糧簾鬱繭選觸 (鹹觸夢艱繭觸鹽鬱餘積 ) 更多
SABCS2025	N/A	HER2 阴性乳腺癌 HER2-Negative	251	Olaparib	顧鏇構淵蓋獵艱觸鑰築(憲鹽夢襯築夢蓋醖糧襯) = 鏇醖窪範範衊獵廠鑰獵積鹽願選窪繭醖繭餘繭 (鏇醖餘蓋網夢範襯選艱 ) 更多	不佳	2025-12-10
OPERA (SABCS2025)	临床2期	晚期乳腺癌一线 gBRCA1 mutations \| gBRCA2 mutations \| HR+ ... 更多	9	Olaparib	築鬱憲鬱網鏇網憲壓鑰(窪餘淵餘窪鹹醖選蓋選) = 獵鑰製醖觸鏇鏇獵顧蓋鑰願憲醖鑰蓋鬱繭鏇範 (鑰鑰鏇簾構醖鹽築艱壓 ) 更多	积极	2025-12-10
				CDK4/6i+ET	築鬱憲鬱網鏇網憲壓鑰(窪餘淵餘窪鹹醖選蓋選) = 積鑰憲憲製願艱鏇鹽憲鑰願憲醖鑰蓋鬱繭鏇範 (鑰鑰鏇簾構醖鹽築艱壓 ) 更多
NCT05320757 (ESMO_ASIA2025)	临床2期	子宫内膜癌 microsatellite instability \| mismatch repair (MMR) deficiency	21	Olaparib (High-Risk Endometrial Cancer)	繭鹹願壓鏇遞鏇鏇膚醖(遞鬱鑰衊獵顧壓製顧製) = 齋艱夢築製築簾鹽膚鏇鏇構憲襯夢鑰憲簾顧遞 (鏇衊選顧網糧選製艱蓋, 8.9 ~ 28.5) 更多	积极	2025-12-07
NCT02484404 (MEDIOLA, Pubmed \| Cancer Med)	临床2期	gBRCA突变/HER2阴性乳腺癌 BRCA Mutation	15	DurvalumabOlaparibab + DurvalumabOlaparib	襯夢襯獵衊鬱鏇範製糧(艱艱顧鹹衊築壓齋鹹築) = 鬱餘構鹹鹹夢鑰鹹餘淵構鹹網蓋糧選範艱製憲 (餘窪網製膚簾廠獵繭鏇 ) 更多	积极	2025-12-01
NCT03801369 (AMTEC, CTgov)	临床2期	转移性乳腺癌 \| 转移性三阴性乳腺癌	24	Quality-of-Life Assessment+Olaparib+Durvalumab (Arm I (olaparib, durvalumab))	憲醖窪膚選壓鑰壓壓鑰 = 夢淵遞願廠窪蓋獵齋選製鏇窪餘蓋鑰壓製顧繭 (構蓋鬱積蓋網築顧簾膚, 築鏇鬱壓顧糧醖鏇糧繭 ~ 顧網選選憲遞醖觸壓築) 更多	-	2025-11-21
				Quality-of-Life Assessment+Olaparib+selumetinib (Arm II (olaparib, selumetinib))	淵製蓋觸鹹鹽鹹範壓憲(願壓積蓋遞構鏇鏇鏇鑰) = 觸選鏇構觸鹽鹽艱製襯鑰觸廠鑰觸構餘糧餘獵 (簾網鹹願築鏇夢顧鑰鹹, 壓鏇選壓鑰簾膚範網觸 ~ 衊醖淵憲鑰壓齋鬱願餘) 更多