更新于：2024-11-01

Anhui Chest Hospital

中国

更新于：2024-11-01

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项与 Anhui Chest Hospital 相关的临床试验

ChiCTR2400090618 / Suspended临床4期IIT

A Multicentre Real-World Study to Assess the Efficacy and Safety of Ametinib Mesylate Tablets in Combination with Vinorelbine Tartrate Soft Capsules Against Ametinib Monotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR-Sensitive Mutations

开始日期2024-10-15

申办/合作机构

Anhui Chest Hospital

ChiCTR2400089107 / Suspended临床4期IIT

The Effectiveness and Safety of Sintilimab Plus Bevacizumab Combined with Pemetrexed and Platinum-Based Drugs in Retrospective Analysis for Advanced Non-Small Cell Lung Cancer Patients Without Targeted Therapy

开始日期2024-10-01

申办/合作机构

Anhui Chest Hospital

NCT06538883 / Not yet recruitingN/AIIT

Efficacy and Safety of Ciprofol Versus Propofol for Sedation in ICU Patients With Mechanical Ventilation: A Multi-Center, Double-Blind, Randomized Controlled Trial

Sedatives are the mostly common prescription for patients with mechanical ventilation due to the disease or therapies.
Ciprofol is a new intravenous anesthetic agent transformed from propofol, and has a similar sedative effect of propofol in previous study.
Whether ciprofol is safe and effective similar with propofol for sedation in ICU patients with mechanical ventilation? Therefor, a multi-center, double-blind, randomized control trial was conducted with a noninferiority design, to compared the rate of successful sedation without hypotension of sedation by ciprofol or propofol in ICU patients with mechanical ventilation.
A Multi-Center, Double-Blind, Randomized Controlled Trial will be launched to evaluate the efficacy and safety of ciprofol versus propofol for sedation in ICU patients with mechanical ventilation.

开始日期2024-08-01

申办/合作机构

Southeast University Affiliated Zhonda Hospital

[+18]

100 项与 Anhui Chest Hospital 相关的临床结果

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0 项与 Anhui Chest Hospital 相关的专利（医药）

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212

项与 Anhui Chest Hospital 相关的文献（医药）

2024-11-01·Advances in Therapy

Efficacy and Safety of Biosimilar SCT510 Compared with Bevacizumab for the First-Line Treatment of Advanced Non-Squamous Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study

Article

作者: Xie, Liangzhi ; Chen, Rixin ; Li, Xingya ; Gai, Wenlin ; Liu, Lianke ; Zang, Kai ; Kong, Li ; Wang, Rui ; Luo, Hui ; Sun, Shenghua ; Ren, Tiejun ; Sun, Hongmei ; Huang, Zhe ; Chen, Weiqiu ; Jiang, Ou ; Li, Gaofeng ; Yu, Yan ; Sun, Meili ; Pan, Zhanyu ; Li, Wei ; Bian, Tao ; Hu, Chunhong ; Lei, Kaijian ; Wei, Zonghui ; Zhu, Bo ; Zhong, Fukuan ; Chen, Shaoshui ; Zhuang, Wu ; Li, Runpu ; Lin, Dang ; Cheng, Ying ; Hang, Xiaosheng ; Shi, Huaqiu ; Gu, Kangsheng ; Wu, Lin ; Sun, Debin ; Liu, Hailong ; Su, Huo ; Zhao, Li ; Lian, Juanwen ; Ren, Wenwen ; He, Miao

INTRODUCTIONSCT510 is a biosimilar to bevacizumab (Avastin) reference product (RP) that is approved for various metastatic cancers. In this study, we aimed to demonstrate the equivalence of SCT510 and bevacizumab in terms of efficacy, safety, immunogenicity and pharmacokinetics (PK) in patients with advanced non-squamous non-small cell lung cancer (NSCLC).METHODSPatients with non-squamous NSCLC were randomized equally to the SCT510 group (comprising SCT510, paclitaxel, and carboplatin) and the bevacizumab group (comprising bevacizumab, paclitaxel, and carboplatin) for 4-6 cycles, followed by maintenance monotherapy with SCT510. The primary endpoint was the objective response rate (ORR) at week 12. Secondary endpoints included 18-week ORR, disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and 1-year survival rate, as well as assessments of safety, immunogenicity, and multi-dose PK analysis.RESULTSBetween March 29, 2019, and April 27, 2021, 989 patients were screened and 567 eligible patients were randomly assigned to the SCT510 group (285 patients) and the bevacizumab group (282 patients). The ORR at week 12 was 52.6% [95% confidence interval (CI) 46.66-58.55%] in the SCT510 group and 52.5% (95% CI 46.47-58.47%) in the bevacizumab group. The ORR at week 18 was 55.4% (95% CI 49.46-61.30%) for SCT510 and 55.7% (95% CI 49.68-61.62%) for bevacizumab. The ORR risk ratio (RR) at weeks 12 and 18 was 0.99 (90% CI 0.873-1.133) and 0.99 (90% CI 0.872-1.114), respectively, both within the pre-specified equivalence margin of 0.75-1.33. There were no differences between the two groups in relation to other secondary endpoints, specifically DCR, DOR, PFS, OS, and 1-year survival rate. The overall safety findings were similar between the two treatment groups, and both SCT510 and bevacizumab RP exhibited low immunogenicity.CONCLUSIONSSCT510 is similar to bevacizumab in clinical efficacy, safety, immunogenicity, and PK in patients with advanced non-squamous NSCLC. The totality of the evidence supports the clinical equivalence of SCT510 and bevacizumab.TRIAL REGISTRATIONNCT03792074.

2024-10-01·Nature Medicine

Benmelstobart, anlotinib and chemotherapy in extensive-stage small-cell lung cancer: a randomized phase 3 trial

Article

作者: Wang, Minghui ; Wang, Qiming ; Xie, Conghua ; Chen, Xingwu ; Zhuang, Wu ; Huang, Chun ; Wang, Jie ; Lin, Haifeng ; Jiang, Ou ; Shu, Yongqian ; Lai, Jinhuo ; Yi, Tienan ; Lin, Daren ; Yu, Yan ; Lu, Ping ; Li, Jinzhang ; Wang, Daqing ; Yang, Huaping ; Zhong, Diansheng ; Fang, Haohui ; Chen, Jianhua ; Zheng, Yulong ; Zhou, Ningning ; Wu, Rong ; Yu, Guohua ; Yang, Runxiang ; Gu, Kangsheng ; Ye, Xianwei ; Li, Baolan ; Xie, Chao ; Sun, Hong ; Zhang, Wei ; Chen, Hualin ; Xu, Xingxiang ; Zhang, Peng ; Wang, Zaiyi ; Cheng, Ying ; Hu, Qun ; Wu, Guowu ; Wu, Di ; Shi, Jianhua ; Wei, Shihong ; Li, Xingya ; Liu, Chunling ; Gu, Yuhai ; Xu, Yanhua

AbstractImmunochemotherapy is the first-line standard for extensive-stage small-cell lung cancer (ES-SCLC). Combining the regimen with anti-angiogenesis may improve efficacy. ETER701 was a multicenter, double-blind, randomized, placebo-controlled phase 3 trial that investigated the efficacy and safety of benmelstobart (a novel programmed death-ligand 1 (PD-L1) inhibitor) with anlotinib (a multi-target anti-angiogenic small molecule) and standard chemotherapy in treatment-naive ES-SCLC. The ETER701 trial assessed two primary endpoints: Independent Review Committee-assessed progression-free survival per RECIST 1.1 and overall survival (OS). Here the prespecified final progression-free survival and interim OS analysis is reported. Patients randomly received benmelstobart and anlotinib plus etoposide/carboplatin (EC; n = 246), placebo and anlotinib plus EC (n = 245) or double placebo plus EC (‘EC alone’; n = 247), followed by matching maintenance therapy. Compared with EC alone, median OS was prolonged with benmelstobart and anlotinib plus EC (19.3 versus 11.9 months; hazard ratio 0.61; P = 0.0002), while improvement of OS was not statistically significant with anlotinib plus EC (13.3 versus 11.9 months; hazard ratio 0.86; P = 0.1723). The incidence of grade 3 or higher treatment-related adverse events was 93.1%, 94.3% and 87.0% in the benmelstobart and anlotinib plus EC, anlotinib plus EC, and EC alone groups, respectively. This study of immunochemotherapy plus multi-target anti-angiogenesis as first-line treatment achieved a median OS greater than recorded in prior randomized studies in patients with ES-SCLC. The safety profile was assessed as tolerable and manageable. Our findings suggest that the addition of anti-angiogenesis therapy to immunochemotherapy may represent an efficacious and safe approach to the management of ES-SCLC. ClinicalTrials.gov identifier: NCT04234607.

2024-09-01·Med

Final analysis of camrelizumab plus chemotherapy for untreated advanced or metastatic esophageal squamous cell carcinoma: The ESCORT-1st trial

Article

作者: Zhang, Yiping ; Wu, Lin ; Lu, Jin ; Sheng, Zhen ; Song, Li ; Min, Xuhong ; Niu, Zuoxing ; Bai, Yuxian ; Zhang, Helong ; Huang, Jing ; Zhao, Kuaile ; Wang, Dong ; Ba, Yi ; Chen, Zhendong ; Wang, Zhiqiang ; Li, Jiancheng ; Gao, Shegan ; He, Mingming ; Liu, Zhihua ; Wang, Jun ; Mao, Teng ; Zhang, Li ; Gu, Kangsheng ; Fan, Qingxia ; Luo, Huiyan ; Feng, Jifeng ; Xu, Rui-Hua ; Fu, Zhichao ; Zhang, Xiaodong ; Zeng, Wanqin ; Cheng, Ying ; Liu, Ying

BACKGROUNDThe interim analysis of the randomized phase 3 ESCORT-1st study demonstrated significantly longer overall survival (OS) and progression-free survival (PFS) for camrelizumab-chemotherapy than placebo-chemotherapy in untreated advanced/metastatic esophageal squamous cell carcinoma (ESCC). Here, we present the final analysis of this study and investigate potential indicators associated with OS.METHODSPatients were randomized 1:1 to receive camrelizumab (200 mg) or placebo, both in combination with up to six cycles of paclitaxel (175 mg/m²) and cisplatin (75 mg/m²). All treatments were administered intravenously every 3 weeks. The co-primary endpoints were OS and PFS assessed by the independent review committee.FINDINGSAs of April 30, 2022, the median OS was significantly longer in the camrelizumab-chemotherapy group compared to the placebo-chemotherapy group (15.6 [95% confidence interval (CI): 14.0-18.4] vs. 12.6 months [95% CI 11.2-13.8]; hazard ratio [HR]: 0.70 [95% CI 0.58-0.84]; one-sided p < 0.0001), with 3-year OS rates of 25.6% and 12.8% in the two groups, respectively. The 2-year PFS rates were 20.4% in the camrelizumab-chemotherapy group and 3.4% in the placebo-chemotherapy group. Adverse events were consistent with those reported in the interim analysis. Higher PD-L1 expression correlated with extended OS, and multivariate analysis identified sex and prior history of radiotherapy as independent indicators of OS.CONCLUSIONSThe sustained and significant improvement in efficacy with camrelizumab-chemotherapy compared to placebo-chemotherapy, along with the absence of accumulating or delayed toxicities, supports the long-term use of camrelizumab-chemotherapy as a standard therapy in untreated advanced/metastatic ESCC.FUNDINGThis study was funded by Jiangsu Hengrui Pharmaceuticals Co., Ltd.

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