Camrelizumab combined with TACE to compare the efficacy and safety of TACE in adjuvant treatment of high recurrence risk hepatocellular carcinoma after radical surgery

开始日期2024-04-30

申办/合作机构

北京大学人民医院

ChiCTR2400090666

/ Recruiting临床2期IIT

Prospective randomized controlled study on whether TACE combined with PVE can reduce the recurrence rate of large liver cancer after surgery

开始日期2024-04-25

申办/合作机构-

100 项与氯烯雌醚相关的临床结果

登录后查看更多信息

100 项与氯烯雌醚相关的转化医学

登录后查看更多信息

100 项与氯烯雌醚相关的专利（医药）

登录后查看更多信息

983

项与氯烯雌醚相关的文献（医药）

2025-03-01·Annals of Hepatology

Camrelizumab combined with transcatheter arterial chemoembolization and sorafenib or lenvatinib for unresectable hepatocellular carcinoma: A multicenter, retrospective study

Article

作者: Li, Han ; Wang, Fei ; Jiang, Xiumei ; Liu, Yu ; Su, Ke ; Xu, Ke ; Chi, Hao ; Wang, Pan

INTRODUCTION AND OBJECTIVESWe initiated this study to explore the efficacy of camrelizumab combined with transcatheter arterial chemoembolization (TACE) plus sorafenib or lenvatinib versus TACE plus sorafenib or Lenvatinib for unresectable hepatocellular carcinoma (HCC).MATERIALS AND METHODSFrom June 2019 to November 2022, 127 advanced HCC patients were retrospectively analyzed in this study. This consisted of 44 patients that received camrelizumab plus TACE plus sorafenib or lenvatinib (triple therapy group) and 83 patients that received TACE plus sorafenib or lenvatinib (double treatment group). The overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR) were compared between the two patient groups.RESULTSOur findings demonstrated that patients received the triple therapy exhibited superior median OS (15.8 vs. 10.3 months, P=0.0011) and median PFS (7.2 vs. 5.2 months, P=0.019) compared to the double treatment group. In addition, the triple therapy group exhibited better 6-month (93.5% vs. 66.3%), 12-month (67.2% vs. 36.3%), and 24-month (17.2% vs. 7.6%) survival rates than the double treatment group. However, the ORR (43.2% vs. 28.9%, P = 0.106) and DCR (93.2% vs. 81.9%, P = 0.084) of the two groups were similar. Subgroup analysis showed that compared with the double treatment group, the triple therapy group had a better mOS for HCC with HBV (15.8 vs. 9.6 months, P = 0.0015) and tumor diameter ≥ 5cm (15.3 vs. 9.6 months, P = 0.00055).CONCLUSIONSCamrelizumab plus TACE and sorafenib or lenvatinib may be a promising treatment approach for the clinical management of unresectable HCC patients.

2025-02-01·International Immunopharmacology

Immunotherapy improved the efficacy of TACE or TACE plus MTTs in HCC patients: A meta-analysis

Review

作者: Guo, Yusheng ; Gong, Bingxin ; Li, Tianxiang ; Kan, Xuefeng ; Zheng, Chuansheng ; Li, Yi ; Yang, Lian ; Pan, Zhenliang

BACKGROUNDAlthough several studies have compared the efficacy and safety of transarterial chemoembolization (TACE) without immune checkpoint inhibitors (ICIs) and TACE with ICIs, there is still a lack of meta-analysis.METHODSPubMed, Embase, Web of Science, and the Cochrane Library were searched until July 2023 for studies comparing the efficacy and safety of TACE without ICIs (TACE ± molecular targeted therapies [MTTs]) and TACE without ICIs (TACE ± MTTs + ICIs). Outcomes included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs).RESULTSA total of 20 studies involving 2587 HCC patients were included in the meta-analysis. Eighteen studies including 2116 patients looked at the difference in OS between TACE ± MTTs or TACE ± MTTs + ICIs. Compared with TACE ± MTTs, TACE ± MTTs + ICIs were associated with significantly improved OS (HR, 0.37; 95 % CI, 0.30-0.46). Thirteen studies including 1650 patients investigated the difference in PFS between TACE ± MTTs or TACE ± MTTs + ICIs. The outcome showed that TACE ± MTTs + ICIs were associated with longer PFS (HR, 0.50; 95 % CI, 0.41-0.61, P < 0.001). Eighteen studies including 1971 patients investigated the difference in tumor response (ORR and DCR) between TACE ± MTTs or TACE ± MTTs + ICIs. The outcomes indicated that TACE ± MTTs + ICIs bring higher ORR and DCR compared to TACE ± MTTs (ORR: OR, 2.39; 95 % CI, 1.97-2.89, P < 0.001; DCR: OR, 2.30; 95 % CI, 1.84-2.88). Moreover, to look at the direct impact of ICIs, we investigated the difference in OS, PFS, ORR, DCR, AEs, and severe AEs between TACE + tyrosine kinase inhibitors (TKIs) and TACE + TKIs + ICIs. The results indicated that the addition of ICIs provided longer OS, longer PFS, higher ORR, and higher DCR, but did not bring additional AEs and severe AEs.CONCLUSIONImmune checkpoint inhibitors improved the efficacy of TACE or TACE plus MTTs and prolonged the survival of patients with hepatocellular carcinoma. Meanwhile, the addition of immune checkpoint inhibitors to the TACE + TKIs did not bring additional adverse events.

2025-02-01·Annals of Surgical Oncology

Hierarchically Positioning Laparoscopic Microwave Ablation in the Therapeutic Span of Early Hepatocellular Carcinoma: A Real-Life Comparative Analysis

Article

作者: Biselli, Maurizio ; Grassini, Maria Vittoria ; Ponziani, Francesca Romana ; Zappa, Marco Antonio ; Cammà, Calogero ; Malerba, Antonio ; Lazzari, Sara ; Casadei Gardini, Andrea ; Ortenzi, Mariano ; Caregari, Silvia ; Stornello, Caterina ; Foschi, Francesco Giuseppe ; Billato, Ilaria ; Benevento, Francesca ; Brolese, Marco ; Golfieri, Rita ; Conti, Fabio ; Grova, Mauro ; Coratella, Fabio ; Chegai, Fabrizio ; Cossiga, Valentina ; Dambina, Valeria ; Migliano, Maria Teresa ; Celsa, Ciro ; Capasso, Mario ; Marra, Fabio ; Inno, Alessandro ; Campani, Claudia ; Giacchetto, Carmelo Marco ; Coccoli, Pietro ; Sacco, Rodolfo ; Palano, Giorgio ; Pelizzaro, Filippo ; Barabino, Matteo ; Furlanetto, Alessandro ; Piscaglia, Fabio ; Dajti, Elton ; Lani, Lorenzo ; Domenicali, Marco ; Stefanini, Benedetta ; Cappelli, Alberta ; Napoli, Lucia ; Borghi, Alberto ; Pelecca, Giorgio ; Cavoli, Tancredi Li ; Ravaioli, Federico ; Sangiovanni, Angelo ; Missale, Gabriele ; Adotti, Valentina ; Cabibbo, Giuseppe ; Masotto, Alberto ; Bevilacqua, Vittoria ; Vidili, Gianpaolo ; Cela, Ester Marina ; Bertellini, Federica ; Rosi, Martina ; Santambrogio, Roberto ; Penzo, Barbara ; Rabatelli, Paola ; Renzulli, Matteo ; Brunetto, Maurizia Rossana ; Ballo, Mattia ; Giuffrida, Paolo ; Mosconi, Cristina ; Facciorusso, Antonio ; Trevisani, Franco ; Olivani, Andrea ; Iavarone, Massimo ; Marchetti, Fabiana ; Sauchella, Assunta ; de Matthaeis, Nicoletta ; Santi, Valentina ; Allegrini, Gloria ; Morisco, Filomena ; Rancatore, Gabriele ; Granito, Alessandro ; Saitta, Carlo ; Biasini, Elisabetta ; Caraceni, Paolo ; Vitale, Alessandro ; Pinto, Elisa ; Dell’Isola, Serena ; Farinati, Fabio ; Muratori, Luca ; Lauria, Valentina ; Marchini, Andrea ; Cillo, Umberto ; Ghittoni, Giorgia

BACKGROUNDLaparoscopic microwave ablation (LMWA) has yet to gain a specific place in treatment guidelines for early hepatocellular carcinoma (HCC). This study compared the outcomes of LMWA and trans-arterial chemoembolization (TACE) for early non-resectable patients with HCC, taking percutaneous radiofrequency ablation (PRFA) as the reference treatment.METHODSA retrospective multicenter observational study was conducted, enrolling non-transplantable, non-resectable patients who had early HCC treated with LMWA (n = 658) from Padua and Milan centers, and with PRFA (n = 844), and TACE (n = 425) from the ITA.LI.CA multicenter database. The matching-adjusted indirect comparison (MAIC) method was used to obtain weighted LMWA and TACE populations similar to the reference PRFA population.RESULTSLaparoscopic ablation showed an excellent safety profile, and MAIC-weighted early postoperative deaths were comparable among the groups. The MAIC-weighted overall survival was similar between the LMWA (1-, 3-, and 5 year survival of 91.0 %, 67.9 %, 47.0 %, respectively) and PRFA (1-, 3- and 5 year survivals of 90.0 %, 64.7 %, 46.6 %, respectively) groups (p = 0.678) and significantly better for the LMWA group than for the TACE group (1-, 3- and 5 year survivals of 84.7 %, 48.8 %, 33.6 %, respectively) (p < 0.001). Weighted multivariate overall survival analysis and competing risk/subgroup analyses confirmed the non-inferiority of LMWA to PRFA and its superiority to TACE. The LMWA- and PRFA-treated patients had a significantly lower risk of HCC-related death (p = 0.004) than the TACE-treated patients (p = 0.001). Conversely, the groups did not differ significantly in terms of non-HCC-related deaths.CONCLUSIONSThe non-inferiority of LMWA to PRFA, its superiority to TACE, and its applicability to a wide range of presentations with few contraindications support its inclusion among radical therapies for treating early-HCC patients.

项与氯烯雌醚相关的新闻（医药）

2024-07-23

·Insight数据库

康方生物启动双抗肝癌 III 期临床试验

7 月 22 日，康方生物在 ChiCTR 平台上注册了一项多中心、随机对照、双盲 III 期临床试验。该研究旨在评估卡度尼利单抗（AK104）联合仑伐替尼及经动脉化疗栓塞术（TACE）（A组）对比卡度尼利单抗安慰剂联合仑伐替尼安慰剂及 TACE（B组）在治疗不可根治、非转移性肝细胞癌患者中的 PFS（登记号：ChiCTR2400087138）。早在今年 4 月 17 日，这项临床试验就分别在 ClinicalTrials.gov 平台（登记号：NCT06371157）与 CDE 临床试验登记与信息公示平台（登记号：CTR20241406）上进行了登记公示。截图来自：Insight 数据库官网卡度尼利单抗是康方生物自主研发的四价 IgG1-ScFv 对称结构的抗 PD-1/CTLA-4 双特异性抗体。该抗体利用独特的 IgG-ScFv 结构，在确保具有肿瘤组织高留存的良好抗原差异化结合的基础上，可快速介导独立的 PD-1 或者 CTLA-4 内吞。此外，卡度尼利单抗的 IgG1 骨架通过增强其结构稳定性，配合 Fc 段的点突变，有效消除了 Fc 段的效应功能，进一步提升治疗的安全性。我国的肝癌发病率在全球范围内居于前列。介入疗法 TACE 是目前中晚期肝癌的主要治疗方法。然而，由于肝癌的高度异质性以及 TACE 治疗后可能引起的血管新生和肝功能损害等问题，实际的肿瘤控制效果仍不理想。近年来，研究表明免疫检查点抑制剂联合靶向治疗和局部治疗在中晚期肝癌治疗中具有显著的临床疗效。这种综合治疗策略不仅可以增强患者的免疫系统反应，抑制肿瘤血管新生，还能够提高肿瘤细胞对治疗的敏感性，从而改善肿瘤控制效果并延长患者的生存时间。多模式的联合治疗方法还克服了单一治疗的局限性，减少了治疗相关副作用，为肝癌患者提供了新的治疗希望和更好的预后选择。在 2024 年 ASCO GI 大会上，康方生物公布了卡度尼利单抗联合仑伐替尼和 TACE 用于中晚期不可切除肝细胞癌（uHCC）的 II 期临床研究结果。研究纳入了 60 名至少接受过 1 剂卡度尼利单抗治疗的患者，中位随访时间为 5.1 个月。结果如下：主要终点：基于 RECIST v1.1 标准，6 个月的 PFS 率为 77.1%（95% CI: 60.8-87.3）。次要终点：根据 mRECIST 标准，6 个月的 PFS 率为 75.6%（95% CI: 59.5-86.0）。根据 mRECIST 标准，ORR 为 85.0%（95% CI: 73.4-92.9），DCR 为 95.0%（95% CI: 86.1-99.0）。安全性和耐受性： 3 级及以上治疗相关不良事件（TRAEs）发生率为 68.9%。与卡度尼利单抗相关的 3 级及以上不良事件发生率为 45.9%。此外，根据 RECIST v1.1 标准，ORR 为 35.0%（95% CI: 23.1-48.4），DCR 为 96.7%（95% CI: 88.5-99.6）。9 名患者（15.0%）根据 mRECIST 标准实现 CR。截图来自：Insight 数据库官网这些结果表明，卡度尼利单抗联合仑伐替尼和 TACE 在治疗中晚期不可切除 uHCC 中表现出较高的疗效和可接受的安全性，特别是在 mRECIST 标准下显示出较高的客观缓解率和疾病控制率。在 2024 ASCO 年会上，卡度尼利单抗联合 TACE 作为新辅助治疗用于高复发风险肝癌患者的 II 期临床研究结果公布。该研究的主要终点显示，在 15 名成功接受切除术的患者中，46.7% 达到了主要病理缓解（MPR）。次要终点方面，基于 mRECIST 标准，11 名患者实现了部分缓解，ORR 为 73.3%；此外，所有患者均实现了疾病控制，DCR 达成率为 100%。研究证明，卡度尼利单抗联合 TACE 作为新辅助治疗在高复发风险肝癌患者中疗效显著，且具有可接受的安全性，为未来临床治疗方案提供了强有力的证据支持。截图来自：Insight 数据库官网目前，全球范围内已有六种双抗进入了针对肝癌的 II 期临床研究。这些抗体包括康方生物的依沃西单抗、阿斯利康的沃苏米单抗、普米斯生物的 BNT327、强生的埃万妥单抗、康宁杰瑞的 Anbenitamab-KN-026 和 Erfonrilimab。随着这些研究的深入，双抗疗法有望为肝癌患者提供更有效的治疗方案。值得一提的是，除肝癌外，卡度尼利单抗目前在多个肿瘤适应症上也有建树。2022 年 6 月，卡度尼利单抗获批上市，用于既往接受含铂化疗治疗失败的复发或转移性宫颈癌患者的治疗。今年 1 月，卡度尼利单抗第二项适应症，即联合奥沙利铂和卡培他滨用于一线治疗不可手术切除的局部晚期复发或转移性胃或胃食管结合部腺癌的上市申请获 NPMA 受理。此外，针对鼻咽癌、非小细胞肺癌的 III 期临床试验也都在顺利推进中。截图来自：Insight 数据库官网封面来源：企业 Logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

ASCO会议临床结果临床3期临床2期

2024-07-02

·BiG生物创新社

2024 ESMO-GI：全球胃肠肿瘤，研究进展和临床思考

2024年欧洲肿瘤学会胃肠道肿瘤研讨会（ESMO GI）已于6月26日到29日在德国慕尼黑召开，与会学者展示了今年胃肠道肿瘤的进展和临床思考，带给我们全球GI研发视角，小编简要汇总，解说有限，原图展示，供国内同仁学习思考。汇总｜冷暖目录：一、胃肠肿瘤合谈1. 胃肠肿瘤方向新的抗体及细胞疗法 2. 胃肠肿瘤的靶向治疗汇总3. KRAS在胃肠肿瘤的进展4. 胃肠道治疗性肿瘤疫苗5. 各类胃肠道肿瘤的新辅助/辅助治疗 ● 新辅助/围手术期化疗在晚期胃及胃食管结合部腺癌展现出疗效。 ● 近期食管癌和胃癌的新辅助/辅助研究。 ● 胆管癌的辅助治疗研究。 ● 胰腺癌围手术期治疗，持续时间越长，生存越长。 ● 直肠癌的术后辅助化疗6. 胃肠癌免疫治疗的进展方向探索7. 新型靶标PKMTY1抑制剂联合FOLFIRI在胃肠肿瘤初展疗效二、结直肠癌1. NEST研究：PD1/CTLA4双免新辅助治疗结直肠癌，MSS/MSI均获益2. 直肠癌的降级治疗思考3. 结直肠癌的后线治疗4. 结直肠癌新辅助治疗讨论5. 左右半结肠是否具有基因突变对EGFR单抗的疗效差异6. EA2201研究：O+Y双免新辅助治疗dMMR/MSI-H直肠腺癌，pCR+cCR率57%7. PD1+靶向+放疗新辅助治疗直肠癌，MSS患者获益8. pMMR结直肠癌的免疫治疗探索9. 结直肠癌肝转移术后化疗的必要性10. 对于不可切除的结直肠癌肝转移患者采用化疗+肝移植，相比单纯化疗OS提升11. 肠道微生物对免疫疗效的影响12. CheckMate8HW对比Keynote177：免疫在MSI-H肠癌一线的讨论三、胃癌1. CLDN18.2的ADC药物IBI343治疗胃腺癌初显疗效2. CLDN18.2靶标在胃癌的进展3. 胃癌HER2表达的定量检测4. KEYNOTE-585研究：胃癌围手术期化免阴性结果后的启发5. ARMANI研究：HER2阴性G/GEJ常规化疗后转紫衫+雷莫卢，相比继续化疗效果更优6. RATIONAL-305研究：替雷利珠单抗联合化疗一线治疗HER2阴性晚期胃癌/胃食管结合部肿瘤7. HER2单抗HLX22联合HLX02+XELOX治疗HER2阳性G/GEJ四、肝癌1. 肝癌治疗路径讨论 2. 中期肝癌局部治疗的多种选择3. 肝癌治疗进展 4. 肝癌肝移植5. ctDNA在监控肝癌复发中的价值五、胆管癌1. TOPAZ-1研究：度伐利尤单抗联合化疗治疗晚期胆管癌3年生存率公布六、食管癌1. RATIONAL-306研究：替雷利珠单抗联合化疗一线治疗食管鳞癌七、胰腺癌1. OPTIMIZE-1研究：CD40拮抗剂联合化疗一线治疗胰腺导管细胞癌，ORR40.4%达主终点2. 胰腺癌近期研究汇总，极低的成功率3. 胰腺癌寡转移处理4. 基因突变引起胰腺癌的发病风险八、神经内分泌肿瘤1. NETTER2研究：PRRT治疗神经内分泌肿瘤显佳绩2. 神经内分泌肿瘤的治疗思路一、胃肠肿瘤合谈 1. 胃肠肿瘤方向新的抗体及细胞疗法此次ESMOGI大会上，汇总展示了众多新靶标的抗体及细胞药物产品初期疗效，例如靶向CLDN18.2的CART（CT041）治疗胃癌，ORR55%； CLDN18.2/CD3的双特异抗体药物IBI389治疗胃癌ORR31%，治疗胰腺导管细胞癌ORR30%；靶向GPC3的CART（C-CAR031）治疗肝癌，ORR50%。CRS是主要的不良反应。 2. 胃肠肿瘤的靶向治疗汇总 3. KRAS在胃肠肿瘤的进展 4. 胃肠道治疗性肿瘤疫苗 5. 各类胃肠道肿瘤的新辅助/辅助治疗新辅助/围手术期化疗在晚期胃及胃食管结合部腺癌展现出疗效。近期食管癌和胃癌的新辅助/辅助研究。胆管癌的辅助治疗研究。胰腺癌围手术期治疗，持续时间越长，生存越长。直肠癌的术后辅助化疗 6. 胃肠癌免疫治疗的进展方向探索 7. 新型靶标PKMTY1抑制剂联合FOLFIRI在胃肠肿瘤初展疗效二、结直肠癌 1. NEST研究：PD1/CTLA4双免新辅助治疗结直肠癌，MSS/MSI均获益在术前1-6周内采用PD1单抗联合CTLA4单抗进行新辅助治疗，17例MSS（微卫星稳定）的结直肠癌患者中，病理缓解率为71%，病理完全缓解率为35%；3例MSI-H（高度微卫星不稳定）的结直肠癌患者中，病理缓解率为100%，病理完全缓解率为67%。 2. 直肠癌的降级治疗思考会场上有学者对直肠癌的围手术期治疗的发展演进进行了回顾，也提出了降级治疗的思考，对于TNT（对OS无明确提升，仅针对高风险人群）、放疗（增加局部控制能力）、手术（在选择性患者中可不作切除）等提出应用范围的思考。 3. 结直肠癌的后线治疗 4. 结直肠癌新辅助治疗讨论 5. 左右半结肠是否具有基因突变对EGFR单抗的疗效差异 6. EA2201研究：O+Y双免新辅助治疗dMMR/MSI-H直肠腺癌，pCR+cCR率57% 7. PD1+靶向+放疗新辅助治疗直肠癌，MSS患者获益采用瑞戈非尼+O药+短疗程放疗新辅助治疗II-III期直肠癌，30例pMMR/MSS患者中， 25%的cPCR，5例cCR。 8. pMMR结直肠癌的免疫治疗探索在单药免疫在pMMR肠癌患者中展现出不佳的疗效后，各种新模式在探索。例如双免的加持，双特异性抗体的研发等。 9. 结直肠癌肝转移术后化疗的必要性肝脏是结直肠癌转移的常见部位，手术切除可以达到很好的治疗效果，但是高复发率也是亟需解决问题。有学者对仅肝转移结直肠癌患者进行了META分析，比较了相比只手术，术前和/或术后添加化疗，可以拥有更长的DFS和OS。 10. 对于不可切除的结直肠癌肝转移患者采用化疗+肝移植，相比单纯化疗OS提升化疗+肝移植的5年生存率为57%，单纯化疗仅为13%，HR=0.37，有明确的生存优势。毒副作用可接受。可作为此类患者新的治疗方案选择，但选择合适的患者是关键。 11. 肠道微生物对免疫疗效的影响除了不同靶点免疫药物在免疫疗效上的突破尝试外，研究显示，调整肠道微生物群也是提高免疫疗效的方法之一。力图AtezoTRIBE研究中，对于具有肠道微生物群的和不具有肠道微生物群对T药的疗效差异。以及黑色素瘤中通过进行粪菌移植进行免疫增效均证明这点。因此在本次ESMOGI会上，肠道微生物群的调节也是免疫治疗突破方向之一，在多处被提及。 12. CheckMate8HW对比Keynote177：免疫在MSI-H肠癌一线的讨论本次ESMO-GI大会公布了Checkmate8HW（O+Y一线治疗MSI-H/dMMR晚期结直肠癌）的生活质量随访结果，相比化疗，24个月的PFS率分别为72%：14%，HRQoL有明显提升。双免在此类人群的一线地位不可撼动。同时有学者将本研究与K药一线治疗研究Keynote177进行了对比，引发了一线选择双免还是单免的讨论。三、胃癌 1. CLDN18.2的ADC药物IBI343治疗胃腺癌初显疗效 CLDN18.2是胃肠肿瘤近几年兴起的新靶点，此次ESMOGI大会，其ADC药物IBI343治疗CLDN18.2中高表达的胃及胃食管结合部腺癌患者，获得31.2%（6mg/kg）、41.4%（8mg/kg）的初步有效率。 2. CLDN18.2靶标在胃癌的进展 3. 胃癌HER2表达的定量检测 4. KEYNOTE-585研究：胃癌围手术期化免阴性结果后的启发 KEYNOTE-585研究评估了K药联合化疗新辅助+术后辅助K药治疗局部晚期可切除GC/GEJ，对比单纯化疗，虽然主终点未达阳性。但本次亚组分析显示在PDL1高表达（＞10%）及MSI-H人群中OS获益显著。 5. ARMANI研究：HER2阴性G/GEJ常规化疗后转紫衫+雷莫卢，相比继续化疗效果更优 6. RATIONAL-305研究：替雷利珠单抗联合化疗一线治疗HER2阴性晚期胃癌/胃食管结合部肿瘤在不同PDL1评级方法及不同PDL1表达水平中，化免相比单纯免疫均表现出更优的生存疗效，具有较好的一致性。 7. HER2单抗HLX22联合HLX02+XELOX治疗HER2阳性G/GEJ 四、肝癌 1. 肝癌治疗路径讨论 2. 中期肝癌局部治疗的多种选择包括Y90的选择性内放射治疗、近距离放射治疗、TACE以及与药物的组合治疗均获得成绩可供中期肝癌方案选择。 3. 肝癌治疗进展 4. 肝癌肝移植 5. ctDNA在监控肝癌复发中的价值五、胆管癌 1. TOPAZ-1研究：度伐利尤单抗联合化疗治疗晚期胆管癌3年生存率公布基于TOPAZ-1研究结果，度伐利尤单抗联合化疗已经获批用于治疗晚期胆管癌，此次ESMOGI大会进一步公布了3年生存结果，I药联合化疗，相比单纯化疗，3年生存率分别为14.6%：6.9%，进一步确定了免疫联合在胆管癌的治疗价值。六、食管癌 1. RATIONAL-306研究：替雷利珠单抗联合化疗一线治疗食管鳞癌在不同PDL1评级方法及不同PDL1表达水平中，化免相比单纯免疫均表现出更优的生存疗效，具有相当的一致性。七、胰腺癌 1. OPTIMIZE-1研究：CD40拮抗剂联合化疗一线治疗胰腺导管细胞癌，ORR40.4%达主终点 2. 胰腺癌近期研究汇总，极低的成功率 3. 胰腺癌寡转移处理 4. 基因突变引起胰腺癌的发病风险八、神经内分泌肿瘤 1. NETTER2研究：PRRT治疗神经内分泌肿瘤显佳绩 177Lu-DOTATATE是一款肽受体放射性核素治疗（PRRT），相比高剂量的长效生长抑素（SSA），在G2及G3级别NET中、胰腺和小肠NET中展现出更优的无事件率和ORR。 2. 神经内分泌肿瘤的治疗思路共建Biomedical创新生态圈！如何加入BiG会员？

免疫疗法疫苗抗体药物偶联物临床结果细胞疗法

2024-01-29

·drugs

Addition of Durvalumab, Bevacizumab to TACE Beneficial in Liver Cancer

MONDAY, Jan. 29, 2024 -- For patients with embolization-eligible unresectable hepatocellular carcinoma (uHCC), the addition of durvalumab (D) and bevacizumab (B) to transarterial chemoembolization (TACE) improves progression-free survival (PFS), according to a study presented at the American Society of Clinical Oncology annual Gastrointestinal Cancers Symposium, held from Jan. 18 to 20 in San Francisco. Riccardo Lencioni, M.D., from the University of Pisa School of Medicine in Italy, and colleagues randomly assigned patients with embolization-eligible uHCC to D + B + TACE, D + TACE, or TACE in a 1:1:1 ratio (204, 207, and 205 patients, respectively). The primary end point was PFS for D + B + TACE versus TACE. The researchers found that PFS was significantly improved for D + B + TACE versus TACE (median, 15.0 versus 8.2 months; hazard ratio, 0.77). Across most prespecified subgroups, the results were consistent. The secondary end point of PFS for D + TACE versus TACE did not reach statistical significance. The objective response rate was 43.6, 41.0, and 29.6 percent, respectively, and median time to progression was 22.0, 11.5, and 10.0 months, respectively, for D + B + TACE, D + TACE, and TACE. Maximum grade 3/4 treatment-related adverse events occurred in 32.5, 15.1, and 13.5 percent, respectively; 0, 1.3, and 2.0 percent, respectively, died due to treatment-related adverse events. "These results of the EMERALD-1 trial have the potential to establish a new standard of care for the treatment of unresectable hepatocellular carcinoma," Cathy Eng, M.D., ASCO expert in gastrointestinal cancers, said in a statement. Several authors disclosed ties to pharmaceutical companies, including AstraZeneca, which manufactures durvalumab and funded the study. Press Release More Information Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床结果ASCO会议临床研究

100 项与氯烯雌醚相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D00269	氯烯雌醚	G03CA06	DB00269

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
性腺机能减退	中国	苏州第壹制药有限公司	1984-01-01
前列腺增生症	中国	苏州第壹制药有限公司	1984-01-01
子宫出血	中国	苏州第壹制药有限公司	1984-01-01

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
肝细胞癌	临床1期	中国	深圳市赛百诺基因技术有限公司	2014-07-01

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


ESMO_IO2023	N/A	晚期肝细胞癌	73	Tislelizumab plus TKIs	(鏇淵觸網鏇鏇醖壓築襯) = 鑰選壓築夢淵願廠夢鑰鹽顧鑰繭繭製窪構淵壓 (願夢簾齋餘顧艱鑰醖憲 ) 更多	-	2023-12-07
				Tislelizumab plus TKIs plus TACE	(蓋顧廠艱遞糧構願憲壓) = 膚網齋簾築艱築醖範蓋蓋壓襯願構鑰壓壓願蓋 (顧齋獵鑰積簾夢襯獵積 ) 更多
113/INT/2021 (ESMO_GI2023)	N/A	二线	1,381	Lenvatinib	(構構襯膚鬱艱廠築積構) = 築齋積蓋夢膚醖選製齋鏇鑰糧糧願醖鹽遞簾鑰 (衊鏇鹽窪糧願壓壓鏇廠 ) 更多	积极	2023-07-01
				Atezolizumab plus bevacizumab	(構構襯膚鬱艱廠築積構) = 蓋鹹餘顧蓋夢衊鹹衊膚鏇鑰糧糧願醖鹽遞簾鑰 (衊鏇鹽窪糧願壓壓鏇廠 )
ASCO2023	N/A	不可切除的肝细胞癌一线 \| 二线	34	Donafenib+TACE+anti-PD1 antibody	(選構窪鏇蓋觸衊壓鏇壓) = Treatment-related adverse events (TRAE) were reported by 30 patients (88.2%), of which 7 patients (20.6%) had grade 3 TRAE. No grade 4 or 5 TRAE was reported. 壓衊製憲蓋醖夢窪窪艱 (鏇鑰衊鏇齋窪廠蓋觸鏇 )	积极	2023-05-31
ASCO2023	N/A	晚期肝细胞癌二线	43	TACE+Regorafenib	艱獵選遞糧廠積構範積(齋艱夢夢選鑰觸鏇繭鏇) = 16.28% 顧鑰觸壓衊遞壓膚鏇衊 (夢鑰遞夢蓋鹹積齋餘鹽 ) 更多	积极	2023-05-31
ASCO 12023 \| ASCO 22023 人工标引	N/A	晚期肝细胞癌二线	94	Regorafenib	(醖齋膚衊構積築夢齋鏇) = 範構艱願憲廠衊齋製齋齋顧鑰網艱廠襯憲鹽淵 (鹽鹽簾憲製鹽餘膚膚淵, 0.45 ~ 7.95)	积极	2023-05-26
				PD-1 inhibitors+TACE+Regorafenib	(醖齋膚衊構積築夢齋鏇) = 艱觸糧製積鹽壓醖繭餘齋顧鑰網艱廠襯憲鹽淵 (鹽鹽簾憲製鹽餘膚膚淵, 7.09 ~ 10.32)
ChiCTR1800018621 (ESMO_ASIA2022) 人工标引	临床4期	肝细胞癌	178	apatinib+TACE	(齋簾淵顧簾窪積壓獵範) = 窪窪簾築鹽選齋獵淵觸醖觸鑰醖遞製顧糧網艱 (構壓構糧築觸窪蓋衊憲, 4.53 ~ 10.15) 更多	积极	2022-12-03
				TACE	(齋簾淵顧簾窪積壓獵範) = 簾蓋網鹹蓋製淵餘築鑰醖觸鑰醖遞製顧糧網艱 (構壓構糧築觸窪蓋衊憲, 2.83 ~ 4.90) 更多
Pubmed 人工标引	N/A	肝细胞癌一线 \| 新辅助	51	TACE+Lenvatinib+Toripalimab	製艱壓鹽構膚願積窪淵(顧襯齋壓艱鑰願簾繭顧) = 築壓範築築簾夢築鏇廠獵鏇壓鑰壓積網齋繭遞 (艱積鹽顧鑰憲鏇齋獵範 ) 更多	积极	2022-09-02
				TACE+Lenvatinib	製艱壓鹽構膚願積窪淵(顧襯齋壓艱鑰願簾繭顧) = 糧網醖願衊願蓋構鏇獵獵鏇壓鑰壓積網齋繭遞 (艱積鹽顧鑰憲鏇齋獵範 ) 更多
Pubmed \| Front Oncol 人工标引	N/A	不可切除的肝细胞癌	110	TACE+PD-1 Inhibitors+Lenvatinib	(範鹽襯憲窪築觸鏇選遞) = 網築壓鹹築獵廠積膚簾壓憲製蓋餘築淵繭觸壓 (網衊夢簾築繭願餘衊願 ) 更多	积极	2022-04-21
				TACE	(範鹽襯憲窪築觸鏇選遞) = 醖構築獵網簾繭膚繭齋壓憲製蓋餘築淵繭觸壓 (網衊夢簾築繭願餘衊願 ) 更多
EASL_LCS2022	N/A	不可切除的肝内胆管癌 hepatitis B/C	32	TACE and lenvatinib	(夢範選淵憲壓夢壓選簾) = The occurrence of any-grade adverse events (AEs) was 81%. The most common AEs were decreased appetite (11 [34.3%]), hypertension (10 [31.2%]), and diarrhea (9[28.1%]) 鬱網壓艱醖鑰觸廠繭繭 (願膚醖蓋醖壓憲衊壓顧 )	积极	2022-02-03
				TACE and lenvatinib plus PD-1 inhibitor
CSCO2021	N/A	肝癌	107	TACE+MWA联合治疗组	齋醖鬱網壓範築齋蓋襯(觸觸夢鹹艱廠襯築夢襯) = 窪鹹鹽衊簾鑰壓鑰襯積築鹽壓鑰餘選獵齋醖繭 (範蓋鏇鹹窪顧選願願襯 ) 更多	-	2021-09-25
				单纯TACE组	齋醖鬱網壓範築齋蓋襯(觸觸夢鹹艱廠襯築夢襯) = 夢廠鹽製鬱鑰壓淵餘餘築鹽壓鑰餘選獵齋醖繭 (範蓋鏇鹹窪顧選願願襯 ) 更多