Phase 1 Trial of Nab-Paclitaxel PIPAC (Pressurized Intraperitoneal Aerosolized Chemotherapy) Given in Combination With Second-Line Therapy for Gastric Cancer With Peritoneal Metastases

This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases). Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. PIPAC delivers chemotherapy, such as nab-paclitaxel, that has been turned into a fine mist (aerosolized) at a high pressure directly into the abdominal cavity. Aerosolized chemotherapy delivered directly into the peritoneal space has been shown to deliver higher drug concentrations to the tumor. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving nab-paclitaxel PIPAC in combination with paclitaxel and ramucirumab may be safe, tolerable, and/or effective in treating gastric cancer patients with peritoneal metastases.

开始日期2025-10-17

申办/合作机构

City of Hope National Medical Center

[+1]

NCT06592664

/ Not yet recruiting临床1/2期

A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating Continuous Infusion of LSTA1 Over 4 Hours When Added to Standard of Care (SoC) Versus a Single Intravenous (IV) Push of LSTA1 When Added to SoC, Versus SoC Alone in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Who Have Progressed on FOLFIRINOX (FORTIFIDE)

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma.
The main questions it aims to answer are:
* is the new drug plus standard treatment safe and tolerable
* is the new drug plus standard treatment more effective than standard treatment
Participants will:
* Visit the clinic three times every 28 days for treatment and tests
* Have CT or MRI scans every 8 weeks while on treatment

开始日期2025-03-01

申办/合作机构

Lisata Therapeutics, Inc.

NCT06576115

/ Not yet recruiting临床2期IIT

Treatment of Patients with Metastatic Pancreatic Cancer with Gemcitabine and Nab-Paclitaxel and Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF)

The goal of this study is to learn if the combination of nab-paclitaxel, gemcitabine and an Amplitude-Modulated Radiofrequency Electromagnetic Fields device (Therabionic P1) is safe and effective for patients with adenocarcinoma of the pancreas.

开始日期2025-03-01

申办/合作机构

Barbara Ann Karmanos Cancer Institute

100 项与白蛋白结合型紫杉醇相关的临床结果

登录后查看更多信息

100 项与白蛋白结合型紫杉醇相关的转化医学

登录后查看更多信息

100 项与白蛋白结合型紫杉醇相关的专利（医药）

登录后查看更多信息

3,165

项与白蛋白结合型紫杉醇相关的文献（医药）

2025-03-01·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Optimally designed PEGylatied arabinoxylan paclitaxel nano-micelles as alternative delivery for Abraxane®: A potential targeted therapy against breast and lung cancers

Article

作者: Hanafy, Nemany A N

Paclitaxel (PTX) binds to spindle microtubules and inhibits mitotic division leading to cell death. However, its wide distribution, high absorption, and less selectively, minimize its application in cancer clinics. In this study, isolated arabinoxylans were used to encapsulate PTX, and then both were covered by polyethylene glycol conjugated to folic acid (FA), to strengthen its specificity to cancerous cells. Beclin-1 and P21 were significantly overexpressed by (79.6 ± 0.97 %, p ≤ 0.00001, &62.2 ± 1.15 % p ≤ 0.0001 in MCF-7 cells) and (74.8 ± 8.04 %, p ≤ 0.0001 &75.3 ± 2.3 %, p ≤ 0.0001, in NSCLCs) respectively after their incubation for 48 h with nano-targeted PTX NPs. Similarly, P53 and GSK3 beta-pSer9 were significantly increased by (63.5 ± 1 % p ≤ 0.0001, & 87 ± 1 % p ≤ 0.0001, in MCF) respectively and (81.5 ± 6 % p ≤ 0.01, & 84.8 ± 3.8 % p ≤ 0.001, in A549) respectively. The findings confirmed the activation of acidic/neutral autophagosomes in acridine orange/ethidium bromide (AO/EB) and nuclear fragmentation was clearly shown by 4', 6-diamidino-2 phenylindole (DAPI) nuclear stains. The findings provide the basis for the potential application of arabinoxylans as a great vehicle for the encapsulation of chemotherapeutic agents such as PTX for target delivery, and also as an immune mediator.

2025-02-01·Biomaterials advances

Tailoring metabolic activity assays for tumour-engineered 3D models

Article

作者: Croagh, Daniel ; Gabrielyan, Anastasiia ; Loessner, Daniela ; Hauser, Sandra ; Curvello, Rodrigo ; Clegg, Julien

Monitoring cell behaviour in hydrogel-based 3D models is critical for assessing their growth and response to cytotoxic treatment. Resazurin-based PrestoBlue and AlamarBlue reagents are frequently used metabolic activity assays when determining cell responses. However, both assays are largely applied to cell monolayer cultures but yet to have a defined protocol for use in hydrogel-based 3D models. The assays' performance depends on the cell type, culture condition and measurement sensitivity. To better understand how both assays perform, we grew pancreatic cancer cells in gelatin methacryloyl and collagen hydrogels and evaluated their metabolic activity using different concentrations and incubation times of the PrestoBlue and AlamarBlue reagents. We tested reagent concentrations of 4 % and 10 % and incubation times of 45 min, 2 h and 4 h. In addition, we co-cultured cancer cells together with cancer-associated fibroblasts and peripheral blood mononuclear cells in gelatin methacryloyl hydrogels and subjected them to gemcitabine and nab-paclitaxel to evaluate how both assays perform when characterising cell responses upon drug treatment. CyQuant assays were conducted on the same samples and compared to data from the metabolic activity assays. In cancer monocultures, higher reagent concentration and incubation time increased fluorescent intensity. We found a reagent concentration of 10 % and an incubation time of 2 h suitable for all cell lines and both hydrogels. In multicellular 3D cultures, PrestoBlue and AlamarBlue assays detected similar cell responses upon drug treatment but overestimated cell growth. We recommend to assess cell viability and growth in conjunction with CyQuant assays that directly measure cell functions.

2025-02-01·Asia-Pacific journal of clinical oncology

C‐reactive protein is a prognostic biomarker in pancreatic ductal adenocarcinoma patients

Article

作者: Waddell, Nicola ; Gebski, Val ; Mukhopadhyay, Pamela ; Kench, James G. ; Bonazzi, Vanessa F. ; Goldstein, David ; Patel, Kalpana ; Gartside, Michael G. ; Keane, Colm ; Lonie, James M. ; Bradford, Julia J. ; Brosda, Sandra ; Loffler, Kelly A. ; Barbour, Andrew P. ; Aoude, Lauren G.

Abstract:

Aim:

The 5‐year survival rate of pancreatic ductal adenocarcinoma (PDAC) is approximately 11% and has only improved marginally over the last three decades. For operable PDAC, resection and adjuvant FOLFIRINOX chemotherapy is standard of care. There is growing interest in perioperative regimens to improve outcomes. The non‐randomized Phase II study “Gemcitabine and Abraxane for resectable Pancreatic cancer” (GAP) demonstrated the feasibility of perioperative gemcitabine/abraxane. Long‐term survival in PDAC requires an effective immune response; hence, we undertook this translational study of the GAP trial cohort to identify immune‐oncology biomarkers for clinical use.

Methods:

We combined Nanostring nCounter technology with immunohistochemistry to investigate the correlation between gene expression and overall patient survival. Findings were investigated in samples from the International Cancer Genome Consortium (ICGC, n = 88) and the Australian Pancreatic Genome Initiative (APGI, n = 227).

Results:

We confirmed that human equilibrative nucleoside transporter 1 (hENT1) expression was not a prognostic marker in PDAC but patients with high levels of hENT1 were more likely to live longer than 24 months post‐surgery. Additionally, CD274 (PD‐L1) and two novel biomarkers of survival, cathepsin W (CTSW) and C‐reactive protein (CRP), were identified in the GAP cohort (n = 19). CRP expression was confirmed in data from the ICGC. Although PD‐L1 and CTSW proteins were not significant across all three cohorts, results show that low CRP mRNA and protein expression are associated with longer overall survival in all three patient groups.

Conclusion:

PDAC patients with long survival have higher hENT1 expression levels. Furthermore, CRP expression is a biomarker of poor prognosis following perioperative chemotherapy and resection in PDAC patients and thus may be useful for identifying patients who could benefit from more aggressive adjuvant strategies.

1,125

项与白蛋白结合型紫杉醇相关的新闻（医药）

2025-01-17

·ioncology

年度盘点丨殷咏梅教授：2024年HER2阳性乳腺癌研究进展

点击上方蓝字关注我们编者按岁序更替，华章日新。2024年已经画上了圆满的句号，并留下了许多令人回味无穷的美好瞬间。肿瘤瞭望特邀江苏省肿瘤医院殷咏梅教授对2024年HER2阳性乳腺癌的研究进展进行“年度盘点”，见证创新治疗带来的临床实践变革。人表皮生长因子受体2（human epidermal growth factor receptor 2，HER2）阳性乳腺癌约占所有乳腺癌的20%～25%[1]，是乳腺癌乃至实体瘤领域抗肿瘤药物研究的“风向标”和“试验田”。尤其是二十一世纪以来，抗HER2治疗得到不断丰富和升级，从大分子单抗到小分子TKI再到抗体偶联药物（ADC），每一步都为我们留下了具有里程碑意义的研究成果。晚期系统治疗一线治疗 1、PHILA研究：2024年SABCS大会上，中国医学科学院肿瘤医院徐兵河院士携PHILA研究最新成果，再登SABCS口头报告[2] PHILA是一项在全国范围内开展的随机、双盲、多中心，安慰剂对照的III期临床研究，旨在比较吡咯替尼联合曲妥珠单抗+多西他赛（PyroHT组）与安慰剂联合曲妥珠单抗+多西他赛（HT组）在HER2阳性晚期乳腺癌一线治疗中的效果。2019年5月6日至2022年1月17日，全国40家中心共入组590例患者。本次SABCS会议上展示了该研究PFS的最终分析结果。此次数据截止时间为2024年4月30日，结果显示，PyroHT组与HT组的中位随访时间分别为35.7个月和34.3个月。PyroHT组和HT组研究者评估的中位PFS分别为22.1个月vs. 10.5个月（HR=0.44；95% CI：0.36～0.53；P＜0.0001）。尽管OS数据尚未成熟，但显示了积极的获益，死亡风险降低36%（HR 0.64，单侧P=0.0038），吡咯替尼组有74.5%的患者可达到4年生存，而对照组为64.3%。 2、EMERALD研究：2024 ASCO大会报道的EMERALD研究[3]，首次将艾立布林（联合曲帕双靶治疗）应用于HER2阳性晚期乳腺癌的一线治疗 EMERALD研究纳入未经过化疗的HER2阳性晚期乳腺癌患者，按1:1进行分组对比曲帕双靶联合艾立布林与联合紫杉类药物疗效和安全性研究。结果显示，艾立布林组患者的中位无进展生存期（PFS：HR=0.95；95%CI：0.76～1.19，P=0.6817）不劣于紫杉组，并且在数值上比紫杉组延长了1.1个月（14.0 vs. 12.9个月），艾立布林组中位治疗持续时间（DOT）为28.1周，较紫杉组（多西他赛18.1周，紫杉醇20周）超出约10周。此外，客观缓解率（ORR：76.8% vs. 75.2%）、临床获益率（CBR：88.8% vs. 86.9%）在数值上也高于紫杉组；OS结果尚未成熟；在安全性方面，艾立布林的皮肤毒性、水肿等不良事件发生率更低。二线/后线治疗 3、DB-03研究：2024年ASCO大会上DB-03研究的生存结果更新[4]，同期《Nature Medicine》杂志在线发表了DB-03研究的长期生存分析结果[5]。 DB-03研究比较了T-DXd和T-DM1在HER2阳性转移性乳腺癌患者中的疗效和安全性，已经改变了临床实践，既往报道的28.8个月的中位PFS给人留下深刻印象，使得大家对其OS结果充满期待。2024年ASCO大会上报道的DB-03研究的生存数据显示： PFS：根据研究者评估，T-DXd组的中位PFS为29.0个月，而T-DM1组为7.2个月，显示出T-DXd相较于T-DM1有显著的PFS提升（HR=0.30；95%CI：0.24～0.38）。36个月时的PFS率，T-DXd组为45.7%，T-DM1组为12.4%。 OS：在数据截止日期（2023年11月20日）时，T-DXd组的中位OS为52.6个月，而T-DM1组为42.7个月（HR=0.73；95% CI：0.56～0.94），表明T-DXd组患者的死亡风险降低了约27%。 ORR：T-DXd组的ORR率为78.9%（206名患者），而T-DM1组为36.9%（97名患者），显示出T-DXd在提高反应率方面的显著优势。CR率为12.6%和4.2%。反应持续时间（DoR）：研究者评估的T-DXd组中位DoR为30.5个月，而T-DM1组为17.0个月，表明T-DXd治疗的反应更持久。 T-DXd在二线治疗中能够使患者的中位生存达到接近5年，意味着这类经治的HER2阳性晚期乳腺癌患者，也能够长期带瘤生存。 4、ACE-Breast-02研究：2024年ASCO大会上，复旦大学附属肿瘤医院胡夕春教授汇报了II/III期ACE-Breast-02研究的中期结果[6] ACE-Breast-02在中国85个中心进行，入组的患者为先前接受过曲妥珠单抗和紫杉醇治疗的不可切除的HER2+（FISH+或IHC3+）晚期乳腺癌患者。先前接受过曲妥珠单抗和紫杉烷治疗的不可切除或转移性乳腺癌患者被按1:1的比例随机分配，接受ARX788或拉帕替尼联合卡培他滨治疗，根据先前的化疗线数（0～1与＞1）和内脏转移（有与无）进行分层。ARX788治疗前未采取任何预防性措施。主要终点是由BIRC评估的PFS。截至2022年12月21日，共有221名患者被随机分配接受ARX788治疗，220名患者接受LC治疗，共发生了240起PFS事件。中位随访11.14个月，根据BIRC的评估，ARX788组的中位PFS为11.33个月，而LC组为8.25个月（HR=0.64，P=0.0006）。在安全性方面，ARX788较为常见的≥3级不良事件是视力模糊（12.3%）、干眼症（9.1%）、角膜病变（5.9%）和间质性肺病（5.9%）等。脑转移（BM）治疗 5、DB-12研究：2024年ESMO大会上，聚焦HER2阳性乳腺癌脑转移患者的DB-12研究在会议首日登场[7]，且研究结果同期发表于国际顶级医学期刊《Nature medecine》杂志 DB-12研究纳入了接受过≤2线治疗后病情进展的HER2阳性晚期乳腺癌成人患者，要求入组患者既往不能应用过图卡替尼，且无脑膜转移，分为BM组（263名；包括稳定或活动性脑转移）或非BM组（241名）。研究设计不允许跨队列比较。主要研究终点是根据RECIST 1.1标准独立中央审查的基线伴BM组的PFS或基线不伴BM组的ORR。次要终点包括CNS PFS、CNS ORR和ORR（基线伴BM组）以及安全性。研究共纳入504例患者，截至2024年2月8日，BM组的中位随访时间为15.4个月，非BM组的中位随访时间为16.1个月。基线存在BM队列的中位PFS为17.3个月（数据成熟度：42.2%），12个月PFS率为61.6%，稳定性和活动性BM患者的12个月PFS率分别为62.9%和59.6%。基线存在BM队列12个月的CNS PFS率为58.9%；在稳定性和活动性BM患者中，这一比例相似，分别为57.8%和60.1%。基线存在BM队列12个月的CNS PFS率。基线存在BM队列的ORR为51.7%，基线可测量基本的患者的ORR达到64.1%。基线时具有可测量的中枢神经系统疾病的BM患者中（n=138），确认的CNS ORR为71.7%，在稳定性和活动性BM患者中CNS ORR分别为79.2%和62.3%。基线无BM队列总人群的ORR达到62.7%，基线时具有可测量疾病患者的ORR可达68.4%。基线伴或不伴BM队列的12个月OS率分别为90.3%和90.6%。基线伴或不伴BM队列的12个月OS率分别为90.3%和90.6%。T-DXd在HER2阳性晚期乳腺癌伴脑转移患者，包括稳定性和活动性脑转移患者中，表现出显著且持久的整体和颅内临床活性，且未出现新的安全信号。 2024年HER2阳性乳腺癌的研究进展早期系统治疗 6、FASCINATE-N研究：复旦大学附属肿瘤医院邵志敏团队李俊杰教授在2024年SABCS大会报道了FASCINATE-N研究中HER2阳性乳腺癌患者队列的数据，介绍了新型HER2 ADC（SHR-A1811）在新辅助治疗中的疗效[8] HER2阳性队列265例患者按1:1:1随机分配至SHR-A1811单药组（n=87）、SHR-A1811+吡咯替尼组（n=88）和白蛋白结合型紫杉醇+卡铂+HP（PCbHP）组（n=90），分别接受8周期、8周期和6周期的新辅助治疗。主要研究终点是意向治疗（ITT）人群的pCR，次要终点包括客观缓解率（ORR）、侵袭性无病生存期（iDFS）、总生存期（OS）以及安全性。结果显示，SHR-A1811组、SHR-A1811联合吡咯替尼组和PCbHP组的pCR率没有显著差异。SHR-A1811组患者的pCR率为63.2%；SHR-A1811联合吡咯替尼组的pCR率为62.5%；而PCbHP组的pCR率为64.4%。安全性方面，SHR-A1811单药组和PCbHP组3/4级不良反应占比分别为44.8%和38.8%，SHR-A1811单药组耐受性较好，因不良事件所致剂量减少、停药比例最低。 7、PHERGain研究：2024年ASCO大会报道的最新数据，分析了PET与MRI成像评估的疗效及其对患者预后的预测能力[9] 2024年ASCO大会公布了比较PHERGain研究中应用两周期HP治疗后的PET与MRI成像结果，以及它们分别预测pCR和3年iDFS的能力，从而评估乳腺MRI作为早期治疗反应指标，替代PET的可能性。这项分析在PHERGain研究的B组中进行：两周期治疗后，79.6%（227/285）的患者为PET应答，47%（134/285）为MRI缓解，82.5%（235/285）实现了MRI减小。其中，共有78.2%（223/285）患者的PET应答和MRI减小上被同等分类，PET反应和MRI减退之间存在高度相关性。另外，结果发现PET应答或MRI减小的患者观察到相似的pCR和3年iDFS率；而无MRI减小的PET无应答者尽管接受了标准的含化疗和HP的新辅助治疗，3年iDFS仍最差。研究结果提示，这项复杂设计的研究或许无法直接比较PET和MRI；但这些数据表明，当PET不可及时，MRI评估肿瘤缩小可以替代PET，用于指导HER2阳性早期乳腺癌患者在HP两周期后的新辅助治疗。 8、TRAIN-3研究：2024年SABCS大会报道的TRAIN-3研究，也通过MRI对患者的治疗效果进行了疗效评估[10] 该研究是在荷兰43家医院开展的一项针对II-III期HER2阳性乳腺癌患者的单臂、2期研究，患者接受最多9个周期的新辅助系统治疗，包括紫杉醇、曲妥珠单抗、卡铂和帕妥珠单抗（PTC-Ptz），一旦在MRI上观察到完全影像学缓解，则进行手术。共有235例HR-患者接受了1-3个周期（n=91，38.7%）、4-6个周期（n=76，32.3%）或7-9个周期（n=68，28.9%）的PTC-Ptz治疗。232例HR+患者接受了1-3个周期（n=69，29.7%）、4-6个周期（n=71，30.6%）或7-9个周期（n=92，39.7%）的PTC-Ptz治疗。中位随访时间为39.7个月（IQR 34.8-45.4），HR-亚组的3年EFS率为92.1%（95% CI：88.5～95.8%），3年OS率为97.8%（95% CI：95.9～99.7%）。HR+亚组的3年EFS率为92.0%（95% CI：88.5～95.6%），3年OS率为98.7%（95% CI：97.2～100%）。经历1-3个周期新辅助化疗并获得pCR的患者，HR-和HR+患者的EFS率分别为96.0%（95% CI：91.6～100%）和97.1%（95% CI：93.3～100%）。4-6个周期治疗的患者中，HR-和HR+患者的EFS率分别为90.8%（95% CI：84.5～97.5%）和92.8%（95% CI：87.0～99.1%），7-9个周期治疗的患者中，HR-和HR+患者的EFS率分别为87.6%（95% CI：79.1～97.0%）和87.1%（95% CI：80.3～94.6%）。研究结果表明，对于II-III期HER2阳性乳腺癌患者，MRI引导的治疗优化与极佳的3年EFS相关。这种方法为这类患者提供了一种新的治疗选择，显著降低了毒性。 9、ATEMPT研究：旨在评估T-DM1作为辅助治疗药物在Ⅰ期HER2阳性乳腺癌患者中的长期疗效，并识别关键的预后预测指标，研究结果于2024年6月发表于JCO杂志[11]。 ATEMPT 是一项多中心、随机、Ⅱ期试验，旨在评估为期1年的 T-DM1 辅助治疗的疗效，并与TH比较在中心确诊的Ⅰ期 HER2 阳性乳腺癌患者中临床相关毒性的发生率。主要终点为 T-DM1与TH方案组的临床相关毒性发生率和 T-DM1治疗组患者的iDFS 。次要终点是无复发间期（RFI），相关分析包括HER2DX基因组工具、HER2异质性的多组学评价和血小板减少的预测因素。中位随访5.8年后，T-DM1组观察到11例 iDFS 事件，5年iDFS 率为97.0%。5年RFI率为98.3%，5年总生存（OS）率为97.8%，5年乳腺癌特异性生存（BCSS）率为99.4%。鉴于仅凭标准的临床病理特征无法识别高危肿瘤，本研究采用了多组学分析，对ATEMPT研究中的187例（37.6%）患者（147例接受T-DM1，40例接受TH）进行了标准化的HER2DX基因组测试。研究发现，与HER2DX高危患者相比，HER2DX低危患者的5年RFI率更高（98.1%vs 81.8%，HR=0.10，P=0.01）和更好的5年iDFS（96.3%vs 81.8%，HR=0.20，P=0.047）。 2024年HER2阳性乳腺癌的研究进展转化研究 10、在基础和转化研究方面，2024年8月26日，美国癌症研究协会官方期刊《癌症研究》在线发表邵志敏教授团队的“Molecular Characterization and Classification of HER2-Positive Breast Cancer Inform Tailored Therapeutic Strategies.”研究报告[12]，标志HER2阳性乳腺癌复旦分型揭晓。该单中心回顾研究对2013年1月1日至2014年12月31日复旦大学附属肿瘤医院乳腺外科连续191例HER2阳性早期乳腺癌术后患者的HER2免疫组化和原位杂交数据进行分析，筛选出180例符合条件的患者。随后对乳腺癌手术标本进行基因、转录、蛋白质、代谢、免疫等多组学分析，该研究根据转录组学确定四种亚型：经典HER2亚型（HER2-CLA）占28.3%，表现出较高的HER2活性和抗HER2治疗显著获益。免疫调节亚型（HER2-IM）占20%，具有免疫激活微环境，可能适合降阶治疗和免疫治疗。管腔样亚型（HER2-LUM）占30.6%，分子特征与激素受体阳性HER2阴性乳腺癌相似，表明内分泌治疗和CDK4/6抑制剂是潜在治疗策略。基底/间质样亚型（HER2-BM）占21.1%，对现有抗HER2双靶向药物治疗效果不佳，可能对酪氨酸激酶抑制剂获益。该研究结果表明，HER2阳性乳腺癌可被进一步分为具有显著不同分子特征的四种亚型，为更个体化的精准治疗铺平道路，故有必要进一步开展多中心大样本前瞻研究进行验证。 2024年HER2阳性乳腺癌的研究进展总结总之，2024年HER2阳性乳腺癌领域无论早期、晚期、转化研究治疗领域继续涌现了许多突破性研究进展，而且抗HER2治疗展现了更加多元化的发展趋势，包括新型化疗、小分子TKI、新型ADC等多种药物。邵志敏教授团队开展的针对HER2阳性乳腺癌“复旦分型”的研究也将为我们带来更加个体化的精准治疗探索。此外，2024年底公布的新版医保目录中，HER2阳性乳腺癌也有新型药物被纳入其中，包括T-DXd这类新型ADC以及帕妥珠曲妥珠单抗皮下制剂这类新剂型的大分子单抗。随着新型药物的可及性持续改善，我国HER2阳性乳腺癌患者将得到更加规范、标准的治疗方案，从而获得更好的生存和生活质量。最后，我要向中国乳腺癌专家致敬，是他们用大爱和辛勤，为乳腺癌患者探索更优诊疗方案；我也要向广大乳腺癌患者致谢，是她们的积极参与，才能促成中国临床肿瘤学科的快速发展。请收下我最诚挚的祝福！ 2024年HER2阳性乳腺癌的研究进展参考文献上下滑动查看更多内容 [1]、Siegel,Rebecca L et al.“Cancer statistics,2022.”CA:a cancer journal for clinicians vol.72,1(2022):7-33.doi:10.3322/caac.2170 [2]、Binghe Xu, et al.“Pyrotinib or placebo in combination with trastuzumab and docetaxel for untreated HER2-positive metastatic breast cancer (mBC): prespecified final analysis of progression-free survival (PFS) of the phase 3 PHILA trial.”2024 SABCS Abstract GS1-03. [3]、Toshinari Yamashita, et al. “Trastuzumab and pertuzumab in combination with eribulin mesylate or a taxane as first-line chemotherapeutic treatment for HER2-positive, locally advanced or metastatic breast cancer: Results of a multicenter, randomized, non-inferiority phase 3 trial in Japan (JBCRG-M06/EMERALD).”2024 ASCO Abstract 1007. [4]、Erika P. Hamilton, et al. “Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients (pts) with HER2+ metastatic breast cancer (mBC): Updated survival results of DESTINY-Breast03.”2024 ASCO Abstract 1025. [5]、Cortés, Javier et al. “Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer: long-term survival analysis of the DESTINY-Breast03 trial.” Nature medicine vol. 30,8 (2024): 2208-2215. doi:10.1038/s41591-024-03021-7 [6]、Xichun Hu, et al.“ACE-Breast-02: A pivotal phase II/III trial of ARX788, a novel anti-HER2 antibody-drug conjugate (ADC), versus lapatinib plus capecitabine for HER2+ advanced breast cancer (ABC).”2024 ASCO Abstract 1020. [7]、Nancy U Lin, et al. Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ advanced/metastatic breast cancer (mBC) with or without brain metastases (BM): DESTINYBreast-12 primary results. 2024 ESMO Abstract LBA18. [8]、Junjie Li, et al. “HER2-Directed Antibody-Drug Conjugate SHR-A1811 in the Neoadjuvant Treatment of HER2-positive Early Breast Cancer: a Prospective, Randomized, Openlabel, Phase 2 Trial.” 2024 SABCS Abstract GS1-04. [9]、Jos´e Manuel P´erez Garc´ıa, et al. “Comparing 18F-FDG positron emission tomography (PET) and breast magnetic resonance imaging (MRI) to predict pathological complete response (pCR) and 3-year invasive disease-free survival (3-y iDFS) in patients (pts) with HER2+ early breast cancer (EBC): An unplanned exploratory analysis of PHERGain trial.”2024 ASCO Abstract 586. [10]、Fleur Louis, et al. “RF1-03: Three-year event-free survival (EFS) of the multicenter phase II TRAIN-3 study evaluating image-guided optimization of neoadjuvant chemotherapy duration in stage II and III HER2-positive breast cancer (BOOG 2018-01).” 2024 SABCS Abstract .RF1-03. [11]、Tolaney, Sara M et al. “Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial.” Journal of clinical oncology : official journal of the American Society of Clinical Oncology vol. 39,21 (2021): 2375-2385. doi:10.1200/JCO.20.03398 [12]、Li, Yu-Wei et al. “Molecular Characterization and Classification of HER2-Positive Breast Cancer Inform Tailored Therapeutic Strategies.” Cancer research vol. 84,21 (2024): 3669-3683. doi:10.1158/0008-5472.CAN-23-4066 （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。

临床结果ASCO会议抗体药物偶联物临床3期临床2期

2025-01-17

·正大天晴药业集团

高光2024：挖潜“人制户品” 解锁奋进新维度

● 百川共进众行致远 | 中国生物制药2025年工作会议在广州举行谢承润：五载启新以变为力构筑“人制户品”四维生态圈 ● “纳米药物”中的佼佼者！正大天晴白蛋白结合型紫杉醇获批上市 ● 正大天晴罗伐昔替尼在美获批临床国内治疗骨纤维化适应症上市申请已获受理 ● 南京顺欣获评省级企业技术中心，“创新引擎”加速新质生产力发展

2025-01-15

·PRNewswire

Regulatory Approval Clears Path for Oncolytics Biotech® to Advance Promising Pancreatic Cancer Treatment, Following a Review of Safety Data

New pancreatic cancer cohort moves forward with full enrollment of 30 patients in Stage 1 SAN DIEGO and CALGARY, AB, Jan. 15, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Germany's medical regulatory body, the Paul-Ehrlich-Institute (PEI), has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study. This cohort is evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®) in newly diagnosed pancreatic ductal adenocarcinoma (PDAC) patients. Following a positive safety review by the independent Data Safety Monitoring Board (DSMB), which recommended continuation, the PEI's approval allows Cohort 5 to progress to full enrollment. Early safety data will be presented at the upcoming 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium later this month, with initial efficacy results expected in the second half of the year. "Pelareorep has the potential to meaningfully improve outcomes for patients with metastatic pancreatic cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "Encouraging tumor response rates observed in an earlier cohort of the GOBLET study underscore pelareorep's promise in this disease. GOBLET Cohort 5 extends our evaluation by testing pelareorep with a different chemotherapy regimen, mFOLFIRINOX, which broadens the range of pancreatic cancer patients who may benefit from this innovative therapy. Positive results from this cohort may ultimately enable pelareorep to benefit the large majority of metastatic pancreatic patients for whom improved treatment options are badly needed." About GOBLET Cohort 5 The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed metastatic PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. A three-patient safety run-in was incorporated to evaluate the safety and tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations. About GOBLET The GOBLET ( Gastrointestinal tum Ors exploring the treatment com Binations with the oncolytic reovirus pe Lar Eorep and an Ti-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups: Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic PDAC patients; Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab in 2nd line or later advanced and unresectable anal cancer patients; and Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients. Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients. About AIO AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: or follow the company on social media on LinkedIn and on X @oncolytics. Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; continued enrollment in the GOBLET study and the expansion thereof to additional participants; our belief that pelareorep is poised to advance to registration-enabling studies for the treatment of breast and pancreatic cancers; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon Patton Director of IR & Communication [email protected] Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 [email protected] Logo - SOURCE Oncolytics Biotech® Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果免疫疗法ASCO会议快速通道临床2期

100 项与白蛋白结合型紫杉醇相关的药物交易

登录后查看更多信息

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
转移性胰腺腺癌	美国	Teva Pharmaceuticals, Inc.	2023-05-11
胰腺腺癌	美国	Bristol Myers Squibb Co.	2013-09-06
非小细胞肺癌	日本	Taiho Pharmaceutical Co., Ltd.	2010-07-23
胰腺癌	日本	Taiho Pharmaceutical Co., Ltd.	2010-07-23
胃癌	日本	Taiho Pharmaceutical Co., Ltd.	2010-07-23
乳腺癌	中国	Abraxis BioScience, Inc.	2008-06-30
转移性乳腺癌	美国	Bristol Myers Squibb Co.	2005-01-07

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
晚期乳腺癌	临床3期	中国	石药集团欧意药业有限公司	2023-04-27
PD-L1阳性三阴性乳腺癌	临床3期	阿根廷	Hoffmann-La Roche, Inc.	2019-12-17
PD-L1阳性三阴性乳腺癌	临床3期	智利	Hoffmann-La Roche, Inc.	2019-12-17
PD-L1阳性三阴性乳腺癌	临床3期	捷克	Hoffmann-La Roche, Inc.	2019-12-17
PD-L1阳性三阴性乳腺癌	临床3期	法国	Hoffmann-La Roche, Inc.	2019-12-17
PD-L1阳性三阴性乳腺癌	临床3期	匈牙利	Hoffmann-La Roche, Inc.	2019-12-17
PD-L1阳性三阴性乳腺癌	临床3期	意大利	Hoffmann-La Roche, Inc.	2019-12-17
PD-L1阳性三阴性乳腺癌	临床3期	墨西哥	Hoffmann-La Roche, Inc.	2019-12-17
PD-L1阳性三阴性乳腺癌	临床3期	秘鲁	Hoffmann-La Roche, Inc.	2019-12-17
PD-L1阳性三阴性乳腺癌	临床3期	波兰	Hoffmann-La Roche, Inc.	2019-12-17

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03240016 (ABLE, CTgov)	临床2期	晚期尿路上皮癌	36	Abraxane+pembrolizumab	齋憲積壓壓鑰鏇餘網窪(製膚窪艱鏇鹽網糧糧顧) = 鹽鬱淵襯構網蓋糧鹽鬱願壓衊築繭艱廠鬱獵艱 (廠繭糧鹹壓構糧醖鹽衊, 衊範製醖築鑰網窪襯艱 ~ 網鏇繭網糧築蓋構繭築) 更多	-	2025-01-16
NCT05244993 (NEWS) 人工标引	临床2期	晚期三阴性乳腺癌一线	43	安罗替尼 +派安普利单抗 +白蛋白紫杉醇	繭構憲醖憲積製觸鏇醖(製蓋壓簾鬱廠簾願憲觸) = 鏇範選繭鏇糧襯遞積網繭膚簾積糧獵構積壓網 (廠簾鹹壓顧艱憲夢壓鏇 ) 更多	积极	2024-12-14
NCT03329248 (QUILT-3.060, CTgov)	临床1/2期	胰腺癌	6	SBRT+GI-4000+lovaza+Leucovorin+ETBX-011+fluorouracil+ALT-803+nab-paclitaxel+cyclophosphamide+haNK for infusion+Bevacizumab+Oxaliplatin+Capecitabine	鹹願齋鏇獵衊鬱築廠憲(積淵艱窪艱簾鬱築淵繭) = 窪淵壓構廠夢鬱築窪獵餘醖淵遞鹽願願範積淵 (鹹願襯網鏇遞鬱築觸淵, 憲壓製鏇鹹範選選鹽糧 ~ 築築壓繭糧廠醖憲窪餘) 更多	-	2024-12-12
NCT03563157 (CTgov)	临床1/2期	转移性结直肠癌	2	SBRT+Aldoxorubicin Hydrochloride+GI-6301+GI-4000+ETBX-061+Cetuximab+ETBX-051+Leucovorin+ETBX-011+5-Fluorouracil+ALT-803+ETBX-021+nab-paclitaxel+CYCLOPHOSPHAMIDE+Avelumab+haNK+GI-6207+Regorafenib+Oxaliplatin+Capecitabine (NANT Colorectal Cancer (CRC) Vaccine)	窪網網築鹽範鑰願餘獵(遞艱遞選願構膚積繭觸) = 獵積淵觸夢衊鹹網觸艱願簾壓鑰構繭襯遞餘蓋 (繭構憲獵範襯獵淵艱獵, 鹽鹹膚廠積衊製窪艱憲 ~ 鏇鬱選壓觸窪夢淵襯衊) 更多	-	2024-12-11
				Regorafenib (Regorafenib)	膚蓋範遞範觸醖淵窪鬱(構鹹夢廠齋廠簾鏇簾壓) = 範艱襯鬱餘鑰觸膚窪選窪簾選鏇簾鑰積鑰鹹廠 (鹽艱憲膚鏇襯鏇選壓齋, 夢網鏇鏇憲網醖膚鹽醖 ~ 顧願淵襯選夢鹹築繭淵) 更多
NEWS 人工标引	临床3期	乳腺癌	-	SYHX2011	築膚衊淵鹽壓顧積鹽壓(憲鏇餘構齋鹹蓋齋襯襯): HR = 1.38 (95% CI, 1.040 ~ 1.842) 更多	积极	2024-12-10
				紫杉醇（白蛋白结合型）
NCT05659056 (SABCS2024) 人工标引	临床2期	HER2阳性乳腺癌新辅助 HER2 Positive	52	pyrotinib + trastuzumab + nab-paclitaxel	膚鬱願鹹網網選簾窪艱(襯膚築範鏇醖襯糧鹹繭) = 廠衊膚糧餘膚選鹹積餘願襯鹹顧構製繭製製願 (憲獵築選築範鹽鹹廠築, 29.0 ~ 56.7) 更多	积极	2024-12-10
				pyrotinib + trastuzumab + nab-paclitaxel (HER2-enriched subtype)	膚鬱願鹹網網選簾窪艱(襯膚築範鏇醖襯糧鹹繭) = 繭鑰餘範夢鏇鬱遞顧醖願襯鹹顧構製繭製製願 (憲獵築選築範鹽鹹廠築, 37.9 ~ 73.2)
NCT02754726 (CTgov)	临床2期	转移性胰腺导管腺癌	35	nivolumab+albumin-bound paclitaxel+Gemcitabine+Paricalcitol+cisplatin	壓憲願夢鬱遞觸獵積襯(壓齋襯艱觸艱遞壓襯繭) = 窪艱衊遞齋糧壓繭簾鏇醖鏇網醖鏇簾淵鏇夢醖 (鑰齋膚願顧夢顧窪廠鑰, 顧窪簾鏇築糧構淵膚襯 ~ 壓憲窪鬱壓膚選願顧壓) 更多	-	2024-12-10
ESMO_ASIA2024	N/A	新辅助 neutrophil-to-lymphocyte ratio (NLR)	142	nab-paclitaxel (Low NLR (<2.1))	淵顧築鹹襯鑰構獵艱鬱(鏇餘觸觸顧夢遞鬱網壓) = DFS in the low NLR group was longer than in the high NLR group 夢遞願蓋製築觸網鏇構 (鹽願鏇餘構憲積醖蓋獵 )	-	2024-12-07
				nab-paclitaxel (High NLR (≥2.1))
NCT03768414 (SWOG 1815, CTgov)	临床3期	不可切除的肝内胆管癌 \| 晚期胆道癌 \| 胆囊肿瘤 ... 更多	452	Nab-paclitaxel+Gem+Cisplatin (Gem+Cisplatin+Nab-paclitaxel)	淵繭鹹淵鹹淵鑰選艱膚(觸鏇遞遞壓顧壓築蓋壓) = 構餘餘範範觸窪窪窪選獵鬱積糧範蓋鏇餘蓋鹹 (壓製鏇壓簾鹽鬱築鬱觸, 窪構鏇鏇廠鏇醖艱壓鑰 ~ 積鹹窪鏇壓窪衊鬱鏇製) 更多	-	2024-10-22
				Gemcitabine+Cisplatin (Gemcitabine + Cisplatin)	淵繭鹹淵鹹淵鑰選艱膚(觸鏇遞遞壓顧壓築蓋壓) = 鑰鏇鬱餘願顧構夢夢選獵鬱積糧範蓋鏇餘蓋鹹 (壓製鏇壓簾鹽鬱築鬱觸, 憲醖襯鹹築選獵鹹鑰觸 ~ 鬱鬱齋簾襯鹹糧網餘淵) 更多
NCT04964960 (CTgov)	临床2期	代谢综合征 \| 非小细胞肺癌 \| 脑转移瘤	3	nab paclitaxel+Carboplatin+Paclitaxel+Pembrolizumab+Pemetrexed	齋鏇壓壓糧襯艱鹽選蓋(範夢憲窪淵遞選鹽膚構) = 鹽範鏇壓夢鹽糧壓壓簾範顧餘醖艱築廠鏇積顧 (窪築鹹鬱壓憲齋網膚鹹, 鹹夢積願糧蓋鑰鹽膚簾 ~ 願製醖窪繭餘夢醖鬱範) 更多	-	2024-10-21