This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before and after surgery (perioperative) in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and/or immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Treatment will be administered according to the current standard of care at the time of enrollment. Chemotherapy options may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine at standard doses according to the treating physician. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Other chemotherapy drugs, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading . Immunotherapy with monoclonal antibodies, such as nivolumab, pembrolizumab, and atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC.

开始日期2025-05-30

申办/合作机构

Alliance for Clinical Trials in Oncology

[+1]

NCT04595981 / Not yet recruiting临床2期IIT

Chemo-embolization for Head and Neck Cancer

The study will evaluate whether adjuvant chemo-embolization increases progression free and/or overall survival relative to standard of care radiation and chemo- and/or immunotherapy in cisplatin-ineligible head and neck cancer patients with an acceptable morbidity rate.

开始日期2025-05-01

申办/合作机构

The University of Alabama at Birmingham

NCT05570422 / Not yet recruiting临床1期

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

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

开始日期2025-04-01

申办/合作机构

KORTUC, Inc.初创企业

100 项与顺铂相关的临床结果

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100 项与顺铂相关的转化医学

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100 项与顺铂相关的专利（医药）

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76,103

项与顺铂相关的文献（医药）

2025-12-01·Journal of Gastrointestinal Cancer

Impact of Retroperitoneal Lymphadenopathy (RPLN) on the Outcomes of Locally Advanced Gall Bladder Cancer (GBC) Following Chemotherapy (CT) or Chemotherapy Followed by Consolidation Chemoradiotherapy (CTRT)

Article

作者: Naik, Nagendra ; Priyanka, Parul ; Agrawal, Sushma

INTRODUCTION:

Retroperitoneal lymphadenopathy is considered a metastatic disease in GBC; however, some surgical series of radical surgery with enlarged RPLN who underwent RPLN dissection have shown results marginally inferior to those without enlarged RPLN. Radiological RPLN comprises a major proportion of advanced non-metastatic GBC. There is dilemma in the intent of treatment to be offered in such cases. We are reporting our series of outcome of GBC with RPLN treated with first-line CT followed by consolidation CTRT.

MATERIALS AND METHODS:

Non-metastatic locally advanced GBC with good performance status (KPS ≥ 80) were initiated on first-line CT (cisplatin-gemcitabine), and thereafter, responders were evaluated by CECT-angiography and PET-CT scan for resectability. If found unresectable, they were offered consolidation CTRT to a dose of 45 Gy by conventional fractionation (3D-CRT technique) along with concurrent capecitabine at 1250 mg/m² to GBC and regional lymphatics including RPLN. Thereafter, boost dose of 9 Gy/5# was given to GBC only. Response assessment was done using CECT abdomen by RECIST criteria v 1.1. Outcomes (overall survival) of the two groups (RPLN vs non-RPLN) were computed with Kaplan-Meier survival curves and chi-square tests using SPSS v 20.

RESULTS:

Among 189 patients of advanced non-metastatic GBC recruited from 2011 to 2022, 80 had RPLN. The demographic features of both groups were comparable. Overall, 68% of the patients were women, 30% underwent upfront stenting for obstructive jaundice, and 90% had T3 and T4 disease. Only 10% had undergone upfront laparoscopic staging and had pathologically proven RPLN. Forty percent of the patients received four cycles of CT only and 50% of the patients received six cycles or more and 33% received CTRT. By RECIST criteria, 10% vs 16% achieved complete response (CR), 39% vs 41% achieved partial response (PR), 16% vs 15% achieved stable disease (SD), 2.7% vs 6% had disease progression (PD), and 14.5% vs 3.7% were non-evaluable in non-RPLN group vs RPLN group, respectively. 12% vs 6% could undergo radical surgery in non-RPLN group vs RPLN group (p = 0.03). The median OS was 9 months (95% CI 7.6-10.3 months) vs 10 months (95% CI 8-9.8 months) (p = NS) in non-RPLN group vs RPLN group, respectively. In those who received CT only, the median OS was 7 months vs 8 months, while in those who received CT followed by CTRT, the median OS was 14 months vs 13 months (p = 0.65) in non-RPLN group vs RPLN group, respectively.

CONCLUSIONS:

Based on this analysis, we conclude that RPLN constitutes a major proportion of advanced non-metastatic GBC and has outcomes similar to those without RPLN if treated with radical intent. RPLN should not be considered a metastatic disease and should be treated with radical intent.

2025-12-01·Journal of Gastrointestinal Cancer

Network Meta-analysis of Randomized Controlled Trials in Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer: Comparisons Involving Ramucirumab

Review

作者: Taipale, Kaisa ; Paine, Abby ; Gupta, Palvi ; D'yachkova, Yulia ; Liepa, Astra M ; Earley-Valovic, Veronika ; Goel, Rajat

PURPOSE:

With relatively few direct comparisons among treatment options for previously treated advanced gastric cancer or gastroesophageal junction (GEJ) cancer, network meta-analysis (NMA) may inform evidence-based decision-making. Ramucirumab plus paclitaxel (RAM + PTX) is a preferred regimen in guideline recommendations. NMA of key outcomes may further characterize the relative clinical value of RAM + PTX.

METHODS:

A systematic literature review of randomized controlled trials of adult patients with previously treated advanced gastric/GEJ cancer informed a NMA which compared overall survival, progression-free survival, and discontinuations due to adverse events. Comparisons were reported relative to placebo/best supportive care (BSC) when possible, otherwise relative to RAM + PTX.

RESULTS:

The base-case NMA focused on second-line treatment only, from 19 of 28 studies identified. For overall survival, seven of 16 regimens were favorable relative to placebo/BSC, with RAM + PTX as the most favorable. For progression-free survival, five of 14 regimens were unfavorable relative to RAM + PTX. For discontinuations due to adverse events, two of 13 regimens were similar to placebo/BSC: ramucirumab monotherapy and fluorouracil; relative to RAM-PTX, all regimens were similar except ramucirumab monotherapy which was favorable and irinotecan + cisplatin which was unfavorable.

CONCLUSION:

This NMA of trials of previously treated gastric/GEJ cancer suggests that RAM + PTX has one of the more favorable clinical profiles.

2025-04-01·BIOMATERIALS

Nanoradiosentizers with X ray-actuatable supramolecular aptamer building units for programmable immunostimulatory T cell engagement

Article

作者: Cai, Kaiyong ; Luo, Zhong ; He, Jinming ; Li, Zhongjun ; Ren, Xijiao ; Zhang, Qiqi ; Li, Menghuan ; Ran, Qian ; Hu, Yan ; Wang, Shuang

The insufficient activation and impaired effector functions of T cells in the immunosuppressive tumor microenvironment (TME) substantially reduces the immunostimulatory effects of radiotherapy. Herein, a multifunctional nanoradiosensitizer is established by integrating molecularly engineered aptamer precursors into cisplatin-loaded liposomes for enhancing radio-immunotherapy of solid tumors. Exposure to ionizing radiation (IR) following the nanoradiosensitizer treatment would induce pronounced immunogenic death (ICD) of tumor cells through cisplatin-mediated radiosensitization while also trigger the detachment of the aptamer precursors, which further self-assemble into PD-L1/PD-1-bispecific aptamer-based T cell engagers (CA) through the bridging effect of tumor-derived ATP to direct T cell binding onto tumor cells in the post-IR TME in a spatial-temporally programmable manner. The CA-mediated post-IR tumor-T cell engagement could override the immunosuppressive barriers in TME and enhance T cell-mediated recognition and elimination of tumor cells while minimizing systemic toxicities. Overall, this work offers an innovative approach to enhance the radio-immunotherapeutic efficacy in the clinics.

1,922

项与顺铂相关的新闻（医药）

2024-11-14

·癌度

抗癌药新组合：PD-1抑制剂联合奥拉帕利治疗驱动基因阴性肺癌遭遇滑铁卢！

大多数非小细胞肺癌确诊的时候处于晚期，无法进行手术治疗。如果患者没有靶向药的治疗机会，那么唯一的机会就是免疫检查点抑制剂，如果不是PD-L1高表达，则还需要将PD-1联合铂类化疗进行组合，总体来说免疫治疗的出现改善了患者的生存期。对于没有EGFR或ALK基因突变的肺癌，PD-1抑制剂联合培美曲塞和铂类化疗是晚期非小细胞肺癌的一线标准治疗。而且患者使用这些药物组合起效，则生存期超过5年的概率更大。奥拉帕利是一种PARP抑制剂，对于乳腺癌和卵巢癌表现出较好的治疗活性。临床前的研究表明，PARP抑制剂可以通过激活干扰素通路和促进免疫细胞浸润肿瘤微环境，来诱导免疫原反应。PARP抑制剂还可以上调PD-L1表达，所以就有了将PARP抑制剂和PD-1抑制剂联合使用的思路。下面就是一项三期临床试验，研究PD-1抑制剂帕博利珠单抗联合奥拉帕利，或帕博利珠单抗联合培美曲塞进行维持治疗，以判断联合治疗的思路。 1、PD-1和PARP抑制剂联合的疗效这是一项三期临床试验，入组的患者为晚期非鳞状非小细胞肺癌，这些患者没有驱动性基因突变且没有经过系统治疗。这些患者首先使用PD-1抑制剂帕博利珠单抗联合培美曲塞和卡铂或顺铂治疗4个周期，对于治疗产生完全缓解、部分缓解或病情稳定的患者分为两组。一组患者每天两次口服奥拉帕利（每次300毫克），每3周使用PD-1抑制剂帕博利珠单抗。另外一组患者属于对照组，则是每3周使用帕博利珠单抗联合培美曲塞。也就是两组患者的治疗区别是维持治疗的药物。这项临床试验入组的患者很多，1003名患者选出了672名患者分为了两组。中位随访时间达到了39.9个月，结果如上面的图示，奥拉帕利联合PD-1的中位无进展生存时间是7.1个月，PD-1联合培美曲塞的中位无进展生存时间是8.3个月，没有显著区别。两组患者的中位总生存时间分别是20.7个月和23个月，也是没有显著区别。也就是这个研究的结论是没有达到预期的终点。安全性方面，3级以上治疗相关不良事件的发生率分别是26.1%和30%。 2、启发和讨论这个研究属于耗资比较大的三期临床试验，但是很遗憾没有达到预期的结果。也就是在临床前探索的PARP抑制剂与PD-1的组合没有达到更好的预期，当然如果能达到预期则患者可以不需要打化疗了，可能这是比较具有吸引力的。但研究结果如此可能也确实没有更好的办法了。不过后面关于这两种药物的组合是否有新的思路或数据我们拭目以待。但是上面的研究结论请大家注意，避免不必要的联合用药错误。欢迎关注癌度，了解全球肿瘤诊疗的最新进展！癌度与吉因加启动的“基因检测人人可及”计划里，仅需要3000元就能检测36个基因，大家可以联系癌度或扫描上面的二维码咨询癌度医学顾问，了解基因检测的相关问题。参考文献： Gray JE, et al., The Phase 3 KEYLYNK-006 Study of Pembrolizumab plus Olaparib versus Pembrolizumab plus Pemetrexed as Maintenance Therapy for Metastatic Nonsquamous Non–Small-Cell Lung Cancer, Journal of Thoracic Oncology (2024), 往期推荐抗癌新药SY-5007首次人体临床试验数据报道，治疗多种肿瘤产生积极疗效！抗癌病毒治疗在脑瘤试验中显示出希望，有患者可见病灶消失！遗憾！免疫治疗药物度伐利尤单抗治疗PD-L1高表达肺癌，未能改善总生存时间！最新临床研究：强效新疗法使晚期乳腺癌的无进展生存期翻倍！

免疫疗法临床3期临床结果加速审批

2024-11-14

·ioncology

2024 ESMO ASIA丨一文纵览上消化道肿瘤领域精彩壁报！

编者按 2024年欧洲肿瘤内科学会亚洲年会（ESMO ASIA 2024）将于当地时间12月6~8日在新加坡召开，届时将公布多项全球及亚太地区的最新科研和临床进展，进一步推动领域内的学术交流。目前大会官网已披露了摘要标题，《肿瘤瞭望消化时讯》特此整理了食管癌、胃癌、胰腺癌等上消化道肿瘤领域的摘要标题，带您快速浏览大会的精彩资讯！胃癌 183P-HER2过表达或无过表达时胃腺癌对新辅助化疗的反应：一项前瞻性观察研究作者：Pratap K.Deb（印第安纳州加尔各答） 157P-腹膜转移胃癌分化轨迹和耐药特征的单细胞表征作者：Haoxin Peng（中国北京） 158P-SOX方案联合伊尼妥单抗一线治疗HER2阳性晚期胃癌的最新疗效与安全性作者：Ying Kong（中国济南） 159P-B细胞的空间组织在胃癌预测和预后中的作用作者：Ryan Tay（新加坡） 160P-胃癌腹膜转移的腹膜生态位进化和微环境重塑作者：Joseph J.Zhao（新加坡） 161P-评估口服维生素B12治疗胃癌患者全胃切除术后维生素B12缺乏症的多中心随机对照试验的Ⅱ期研究作者：Three Aoyama（日本横滨） 162P-围手术期FLOT治疗胃癌和胃食管交界处癌实现PCR的疗效：单机构经验的回顾性分析作者：Xue Ru Ting（乔治市，MY） 163P-腹腔镜辅助胃切除术和常规胃切除术胃癌患者术后饮食摄入量的比较作者：Junya Morita（日本横滨） 164P-一项评估安罗替尼联合特瑞普利单抗作为一线方案治疗PS 2晚期胃癌患者的疗效和安全性的开放标签、单臂、Ⅱ期试验作者：刘可（中国上海） 165P-局部晚期胃癌新辅助治疗后病理完全缓解的预后分析：一项全国性、多中心、回顾性研究作者：Jie Chen（中国上海） 166P-幽门螺杆菌感染胃癌样本中CHOP、GRP94和干性状态之间的相互作用作者：Fatemeh Alizadeh（马什哈德，爱尔兰） 167P-与老年Ⅱ/Ⅲ期胃癌患者早期复发相关的因素：一项回顾性队列研究作者：Yu-Hsuan Shih（台中市） 168P-肌肉减少症作为接受手术和辅助化疗的Ⅱ~Ⅲ期胃癌患者的预后指标作者：Jeong Eun Kim（韩国光明） 169P-真实世界研究中PD-1抑制剂、曲妥珠单抗和一线化疗治疗HER-2阳性晚期胃癌的疗效和预后作者：刘宝瑞（中国南京） 170P-通过多模式血浆游离DNA分析鉴别恶性和良性胃病变作者：Ho D.Vo（越南胡志明市） 171P-一项关于80岁及以上Ⅱ/Ⅲ期胃癌患者辅助S-1化疗的多中心调查作者：Ai Harinauchi（日本） 172P-环状RNA谱确定circATXN1失调可作为胃癌的一个增殖因子和预后标志物作者：Jie Chen（中国上海） 173P-胃腺癌位置重要吗？来自单个肿瘤中心的回顾性研究作者：Alaaeldin Shablak（英国南安普敦） 175P-副干酪乳杆菌ZJUZ2-3通过3-IAA抑制NF-κB通路来抑制胃肿瘤发生作者：Rui Yang（中国杭州） 176P-DHX9及其靶基因AURKA通过PI3K/AKT和TNF信号通路在胃癌中的功能和机制作者：Zuhua Chen（中国武汉） 177P-HGF介导的MAP17在胃癌细胞增殖和转移中的重要作用作者：ByeongIl Jang（韩国大邱）食管癌 178P-KEYNOTE-859研究更新：帕博利珠单抗+化疗治疗晚期HER2阴性胃癌或胃食管结合部（G/GEJ）癌作者：Lina Yin（美国凯尼尔沃思） 179P-个性化微小残留病分析可预测接受根治性放疗的食管癌的预后作者：Lin-Rui Gao（中国北京） 180P-微创海绵细胞学检查在食管鳞状细胞癌和胃贲门腺癌筛查中的应用评估作者：Zhiyuan Fang（中国北京） 181P-围手术期亚叶酸、奥沙利铂、多西紫杉醇和S-1（LOTS）治疗局部晚期胃癌或胃食管结合部腺癌的疗效、安全性及游离DNA分析：一项前瞻性Ⅱ期试验作者：Chih Chieh Yen（台南市中环） 182P-东亚地区HER2阳性局部晚期或转移性胃或胃食管结合部腺癌患者的真实世界治疗模式作者：Do-Youn Oh（韩国首尔） 144P-辅助放化疗在食管角化鳞状细胞癌治疗中的作用作者：Mohamed Z.Elkarany（亚历山大市，EG） 186P-每周对比每月新辅助顺铂和氟尿嘧啶放化疗方案在局部区域食管鳞状细胞癌中的疗效和安全性作者：Cheng-Lun Lai（台湾台中市） 187P-卡瑞利珠单抗在晚期食管癌中的有效性、安全性和使用模式：基于来自三项前瞻性观察性队列研究的987例患者的个体病例数据（IPD）汇总分析作者：鲁智豪（中国北京） 188P-原发肿瘤和淋巴结病理消退对新辅助化疗免疫治疗后局部晚期食管鳞状细胞癌患者复发和生存率的影响作者：Yixin Li（中国南京） 189P-NC18（一种新型HER2靶向ADC）对Enhertu耐药CDX模型的优越的抗肿瘤活性作者：Zhi Li（中国北京） 190P-替雷利珠单抗治疗食管癌的系统评价和荟萃分析作者：Hashim Talib Hashim（Karbala） 191P-来自印度南部的资源有限环境中接受多模式治疗的非转移性癌食管患者的真实世界数据作者：Ravi Teja R.Matta（印第安纳州拉贾蒙德里） 192P-探索氯硝柳胺在食管鳞状细胞癌中对EHMT2的调节作用作者：I-Chen Wu（台湾高雄市） 193P-DCLK1的激酶活性驱动其在食管鳞状细胞癌中的促干性作用作者：Yuping Yang（中国福州） 194P-呋喹替尼联合S-1治疗一线免疫治疗失败后ESCC患者的剂量探索结果更新作者：Ningning Li（中国北京） 195P-miR-10a-5p靶向TFAP2C促进食管癌的顺铂耐药作者：Kiran Pasbola（印第安纳州新德里） 196P-可切除胃和胃食管结合部癌的围手术期FLOT+免疫治疗的系统评价和荟萃分析作者：Lorenz Fort E.Revillas（奎松市，菲律宾） 198P-新辅助多西他赛加顺铂、5-FU治疗可切除局部晚期食管鳞状细胞癌后，辅助纳武利尤单抗治疗的疗效和安全性作者：Nozomu Ogura（日本） 244P-基因组分析检测对胃肠道神经内分泌癌治疗结果的影响作者：Toshiki Ozato（日本冈山） 263TiP-TroFuse-015：TROP2定向抗体-药物偶联物sac-TMT对比医生选择的方案治疗经治转移性胃食管腺癌的Ⅲ期研究作者：Kohei Shitara（日本） 264TiP-一项评估德曲妥珠单抗（trastuzumab deruxtecan，T-DXd）联合rilvegostomig和化疗治疗HER2阳性（HER2+）和HER2低表达的胃或胃食管结合部腺癌（GEJA）患者的Ⅰb/Ⅱ期开放标签研究：DESTINY-Gastric03研究第4部分作者：Yelena Y.Janjigian（美国纽约） 265TiP-Ⅰ/Ⅱ期开放标签、伞式平台设计的研究药物联合或不联合pembrolizumab和/或化疗对既往接受过PD-（L）1抑制剂治疗的晚期食管癌患者的研究：KEYMAKER-U06子研究作者：Sean Kato（日本） 266TiP-替雷利珠单抗联合S-1对于新辅助免疫化疗后根治性切除术后残留原发病灶和淋巴结阴性食管鳞状细胞癌患者的疗效：一项Ⅱ期多中心试验（PPIO-008）作者：Yingjian Wang（中国重庆） 267TiP-CHAPTER-GIST-101：pimitespib联合伊马替尼治疗伊马替尼难治性胃肠道间质瘤患者的Ⅰ期研究作者：WeiPeng Yong（新加坡）胰腺癌 250P-评估液体活检衍生的循环肿瘤DNA（ctDNA）作为预测生物标志物对早期胰腺癌治疗反应的影响作者：Hashim Talib Hashim（Karbala） 252P-XELOXIRI方案在不可切除胰腺导管腺癌患者中的安全性和有效性作者：Biyang Cao（中国北京） 253P-预后营养指数是接受新辅助化疗和手术切除的胰腺癌患者继续S-1辅助化疗的独立危险因素作者：Shinnosuke Kawahara（日本横滨） 255P-NALLONG研究的亚洲队列中既往接受过脂质体伊立替康治疗的转移性胰腺导管腺癌长期幸存者的真实世界结果作者：Chang hoon Yoo（韩国首尔） 256P-胰腺导管腺癌中的PIK3CA突变作者：Omali Pitiyarachchi（澳大利亚兰德威克） 257P-“H”至“H”精准新辅助化疗可提高胰腺癌的可切除率作者：Yonggang He（中国重庆） 258P-真实世界背景下晚期胰腺癌患者治疗方案和总生存期的当前趋势作者：Hiroshi Imaoka（日本） 259P-伊立替康脂质体为基础的方案在中国晚期胰腺癌患者中的应用：一项前瞻性、多中心、观察性真实世界研究作者：Jin Xu（中国上海） 260P-NALIRIFOX作为基于吉西他滨的化疗后转移性胰腺癌的后续治疗：单中心真实世界经验作者：Hisn-Chen Lin（台湾嘉义市）（来源：肿瘤瞭望消化时讯）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2期放射疗法

2024-11-13

·PRNewswire

Intensity Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update

First patient dosed in randomized, Phase 2 study in presurgical triple negative breast cancer SHELTON, Conn., Nov. 13, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, announces third quarter 2024 financial results and provides a corporate update. Corporate Update INVINCIBLE-3 Study: a Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second and third line treatment for certain soft tissue sarcoma subtypes. The INVINCIBLE-3 Study is expected to enroll 333 patients and initiate sites in eight countries. The primary endpoint in the INVINCIBLE-3 Study is overall survival. July 2024: the first patients were dosed in the U.S. in the INVINCIBLE-3 Study. July 2024: authorization received from Health Canada to initiate the INVINCIBLE-3 Study in Canada. September 2024: authorization received from The European Medicines Agency to initiate the INVINCIBLE-3 Study in Europe. October 2024: authorization received from Australia's Therapeutic Goods Administration to initiate INVINCIBLE-3 Study in Australia. INVINCIBLE-4 Study: a Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care ("SOC") treatment in patients with early-stage, operable triple-negative breast cancer ("TNBC") and SOC alone. The primary endpoint is the pathological complete response ("pCR") rate in the primary tumor and affected lymph nodes. The INVINCIBLE-4 Study is expected to enroll approximately 54 patients in Switzerland and France. September 2024: authorization from the Swiss Medic and the Swiss Ethics Commission to initiate the INVINCIBLE-4 Study. October 2024: first patient dosed in the INVINCIBLE-4 Study. "This has been an excellent quarter of regulatory success in multiple countries. We received the regulatory authorizations needed to initiate sites in eight countries for our Phase 3 global sarcoma study and our Phase 2 breast cancer study in Switzerland," said Lewis H. Bender, Intensity Founder, President, and CEO. "Our efforts now turn to site activation and patient recruitment. We remain committed to exploring our new treatment that causes immunological cell death in severe diseases such as soft tissue sarcoma and triple-negative breast cancer. We are excited that our drug will be tested in multiple countries on three continents. INT230-6's ability to debulk tumors and activate an immune response is now in late-stage testing for two indications. We expect that the results from these ongoing studies could potentially demonstrate a meaningful clinical benefit for patients with high unmet need in both the metastatic and local disease settings." Third Quarter 2024 Financial Results Research and development expenses were $2.2 million for the three months ended September 30, 2024, compared to $1.4 million for the same period in 2023. The increase was primarily due to preliminary work related to the INVINCIBLE-3 Study, and to a lesser extent, increased expenses related to salary, benefits, and stock-based compensation. General and administrative expenses were $1.4 million for the three months ended September 30, 2024, compared to $1.1 million for the same period in 2023. The increase was primarily due to increased expenses related to salary, benefits and stock-based compensation, and higher directors and officers insurance. Overall, net loss was $3.5 million for the three months ended September 30, 2024, compared to a net loss of $2.3 million for the three months ended September 30, 2023. As of September 30, 2024, cash and cash equivalents totaled $2.8 million, which the Company expects will be sufficient to fund operations into the first quarter in 2025. About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression which often occurs with systemic chemotherapy. About Intensity Therapeutics Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies and enrolled over 200 patients using INT230-6; a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research SAKK (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response ("pCR") is the endpoint. For more information about Intensity, including publications, papers and posters about its novel approach to cancer therapeutics, visit . Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's SEC filings, which can be obtained on the SEC website at . Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact: Justin Kulik [email protected] (558) 230-6401 Media Contact: Jules Abraham CORE IR [email protected] SOURCE Intensity Therapeutics 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2期免疫疗法临床3期财报

100 项与顺铂相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00275	顺铂	L01XA01	DB00515

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
胆道癌	日本	Nippon Kayaku Co., Ltd.	2012-02-22
恶性胸膜间皮瘤	日本	Nippon Kayaku Co., Ltd.	2007-01-04
儿童恶性实体瘤	日本	Nippon Kayaku Co., Ltd.	2005-09-15
淋巴瘤	日本	Nippon Kayaku Co., Ltd.	2005-09-15
骨癌	日本	Nippon Kayaku Co., Ltd.	2005-02-14
子宫内膜癌	日本	Nippon Kayaku Co., Ltd.	2005-02-14
生殖细胞瘤	日本	Nippon Kayaku Co., Ltd.	2004-05-31
肝细胞癌	日本	Nippon Kayaku Co., Ltd.	2004-01-29
骨肉瘤	日本	Nippon Kayaku Co., Ltd.	1999-12-21
小细胞肺癌	日本	Nippon Kayaku Co., Ltd.	1999-12-21
胃癌	日本	Nippon Kayaku Co., Ltd.	1990-06-03
食管癌	日本	Nippon Kayaku Co., Ltd.	1988-05-30
神经母细胞瘤	日本	Nippon Kayaku Co., Ltd.	1988-05-30
宫颈癌	日本	Nippon Kayaku Co., Ltd.	1988-05-30
非小细胞肺癌	日本	Nippon Kayaku Co., Ltd.	1986-08-28
肾肿瘤	日本	Nippon Kayaku Co., Ltd.	1983-09-21
前列腺癌	日本	Nippon Kayaku Co., Ltd.	1983-09-21
尿路上皮癌	日本	Nippon Kayaku Co., Ltd.	1983-09-21
输尿管肿瘤	日本	Nippon Kayaku Co., Ltd.	1983-09-21
膀胱癌	美国	HQ Specialty Pharma Corp.	1978-12-19

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
输卵管癌	临床3期	美国	GSK Plc	2024-03-08
原发性腹膜癌	临床3期	美国	GSK Plc	2024-03-08
恶性胸腔积液	临床3期	中国	江苏先声药业有限公司	2021-05-31
转移性胃腺癌	临床3期	美国	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	日本	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	阿根廷	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	比利时	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	加拿大	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	捷克	Eli Lilly & Co.	2015-01-20
转移性胃腺癌	临床3期	丹麦	Eli Lilly & Co.	2015-01-20

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临床结果

适应症

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


NCT00980954 (CTgov)	临床3期	宫颈癌	238	intensity-modulated radiation therapy+cisplatin (Arm I: Cisplatin/Radiation Therapy)	壓壓範製鑰淵選鹹鹹餘(窪遞襯獵觸淵糧選製網) = 壓簾膚製醖蓋鏇衊齋繭艱遞醖簾襯醖獵網願蓋 (蓋壓繭夢獵壓鹹淵膚夢, 構鏇夢餘鏇獵範網築憲 ~ 觸齋鏇築廠夢衊窪夢觸) 更多	-	2024-11-06
				intensity-modulated radiation therapy+carboplatin+paclitaxel+cisplatin (Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel)	壓壓範製鑰淵選鹹鹹餘(窪遞襯獵觸淵糧選製網) = 鏇鏇顧糧築鏇襯獵醖鬱艱遞醖簾襯醖獵網願蓋 (蓋壓繭夢獵壓鹹淵膚夢, 構餘窪獵壓齋鹽構顧衊 ~ 獵齋遞範糧簾鹹鬱顧遞) 更多
NCT04989218 (ICC, CTgov)	临床1/2期	肝内胆管癌	1	Tremelimumab+Gemcitabine+Cisplatin+Durvalumab	遞構憲製夢衊選齋鑰製(築鹹繭糧壓築淵廠廠鏇) = 遞蓋遞糧選構鹽齋膚憲淵淵願壓艱醖鏇艱願襯 (夢觸憲衊獵膚顧繭製廠, 蓋構構選網淵憲網鏇選 ~ 範窪襯壓鹹鏇簾獵壓網) 更多	-	2024-11-05
NCT02641847 (BCTOP-T-A01, Literature) 人工标引	临床3期	三阴性乳腺癌	498	docetaxel+doxorubicin or epirubicin+cyclophosphamide+gemcitabine+cisplatin (High risk group A)	選鏇鏇醖餘獵築淵廠鑰(鏇鑰鹹淵鏇壓糧顧願鹹) = 膚遞積鑰願淵鬱築壓艱構遞鏇簾構製範範鬱鹹 (願鹽淵鹽築觸窪餘獵艱 ) 更多	积极	2024-10-23
				docetaxel+doxorubicin or epirubicin+cyclophosphamide (High risk group B)	選鏇鏇醖餘獵築淵廠鑰(鏇鑰鹹淵鏇壓糧顧願鹹) = 鬱簾壓憲願網選夢製鬱構遞鏇簾構製範範鬱鹹 (願鹽淵鹽築觸窪餘獵艱 ) 更多
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)	獵艱淵膚醖鏇壓憲獵襯(醖鑰築獵淵繭蓋襯淵鏇) = 憲製獵衊鹽壓獵築範蓋觸觸鑰醖鑰鬱壓襯廠膚 (膚壓網衊餘觸鹽鹹簾糧, 範積鬱繭積範鑰壓膚鑰 ~ 鹽鏇衊醖窪獵選遞窪鹽) 更多	-	2024-10-22
				Gemcitabine+Cisplatin (Gemcitabine + Cisplatin)	獵艱淵膚醖鏇壓憲獵襯(醖鑰築獵淵繭蓋襯淵鏇) = 構遞艱願鬱齋壓構淵鑰觸觸鑰醖鑰鬱壓襯廠膚 (膚壓網衊餘觸鹽鹹簾糧, 鏇遞齋齋顧鹽襯醖鬱網 ~ 衊淵築艱餘夢鹹觸繭選) 更多
NCT01088906 (Phalcis, CTgov)	临床2期	晚期肺非小细胞鳞癌 \| 非鳞状非小细胞肺癌	57	Cisplatin+Pemetrexed (EXPERIMENTAL ARM)	壓艱鏇齋糧鏇壓餘窪襯(簾觸糧鏇製鏇繭壓鹹顧) = 顧繭簾鑰齋鹹獵淵構網積鬱膚窪鏇糧獵醖鬱窪 (蓋繭鬱襯衊鬱餘憲網遞, 鏇壓壓繭鬱淵選艱餘願 ~ 鏇壓艱鬱鏇網蓋顧積淵) 更多	-	2024-10-15
				Cisplatin+Pemetrexed (Experimental Arm: Pemetrexed Plus Cisplatin)	鹹壓醖膚繭觸廠襯壓觸(衊膚築鹹壓廠簾構願鹽) = 顧鑰鏇獵積繭築範製糧襯觸壓鏇製膚廠淵齋窪 (鑰艱餘鹽鏇艱繭襯簾鹹, 選繭構艱憲積鏇選網範 ~ 選衊獵觸餘製顧鑰簾醖) 更多
NCT01074970 (BRE09-146, CTgov)	临床2期	三阴性乳腺癌	135	Cisplatin (Arm A: Cisplatin Monotherapy)	觸簾遞範壓醖窪鬱鹹網(選範齋膚艱網鹽蓋製簾) = 壓醖鑰餘廠鏇積顧鑰繭淵範範窪憲襯廠獵構壓 (築糧鬱壓構願顧願簾簾, 壓獵膚選鏇網夢願簾鑰 ~ 顧獵齋鹹選餘廠觸鑰繭) 更多	-	2024-09-19
				Rucaparib+Cisplatin (Arm B: Combination Therapy)	觸簾遞範壓醖窪鬱鹹網(選範齋膚艱網鹽蓋製簾) = 構窪選膚蓋網選鏇積網淵範範窪憲襯廠獵構壓 (築糧鬱壓構願顧願簾簾, 襯繭衊鹽鹹鹽壓夢構構 ~ 艱艱廠襯鏇製襯願壓衊) 更多
NCT02202772 (ESMO2024) 人工标引	临床2期	非肌层浸润性膀胱尿路上皮癌	33	cabazitaxel+gemcitabine+cisplatin	憲齋遞顧網構鬱獵簾簾(艱糧壓鹽鬱顧簾範簾艱) = 簾蓋顧廠鏇積觸積構糧憲淵範艱遞艱膚獵構繭 (積遞膚簾築夢齋繭鹽餘 ) 更多	积极	2024-09-15
ESMO2024 人工标引	临床2期	非精原细胞生殖细胞肿瘤	34	Paclitaxel+ifosfamide+cisplatin	壓襯鹹淵膚鏇衊製簾衊(鬱鹹獵積醖鬱顧獵築膚) = 構獵鏇鑰窪鑰願顧衊窪餘餘鏇蓋選鹹夢製築衊 (選鏇簾鏇壓築餘遞鏇窪 ) 更多	不佳	2024-09-15
ESMO2024 人工标引	临床2期	非小细胞肺癌	120	Cisplatin 75mg/m2 (group I)	顧醖憲鏇鑰鬱膚繭鹹鏇(鹹膚壓淵遞憲構憲糧獵) = more frequent in group I 艱蓋艱範醖糧壓簾蓋鹹 (觸顧窪鏇窪鹹願積襯繭 ) 更多	积极	2024-09-14
				Cisplatin 50mg fixed dose (group II)
JPRN-jRCTs031180135 (JCOG1008, ESMO2024) 人工标引	临床2/3期	头颈部鳞状细胞癌	261	3-weekly Cisplatin+RT	獵齋範鏇窪範壓鬱齋顧(襯網壓膚憲憲壓憲衊壓) = 鹹餘製觸網觸窪齋蓋簾糧願廠夢遞襯淵衊獵積 (膚蓋繭鹽糧醖製簾遞蓋 ) 更多	积极	2024-09-14
				Weekly Cisplatin+RT	獵齋範鏇窪範壓鬱齋顧(襯網壓膚憲憲壓憲衊壓) = 夢簾觸夢選鑰簾壓築夢糧願廠夢遞襯淵衊獵積 (膚蓋繭鹽糧醖製簾遞蓋 ) 更多