A Multicenter, Prospective, Randomized Controlled Study Comparing the Efficacy and Safety of CLAG(Cladribine, Cytarabine and G-CSF) Combined With Venetoclax and CLAG in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

This is a multicenter, prospective, randomized controlled clinical study comparing the efficacy and safety of CLAG+VEN and CLAG regimens in relapsed/refractory(r/r) AML.

开始日期2025-02-01

申办/合作机构

Liuzhou People'S Hospital

[+20]

NCT06767722

/ Not yet recruitingN/AIIT

Effectiveness of a Lifestyle Intervention for Pregnant Women with Abnormal Glucose Metabolism in Early Pregnancy: EAGM Randomized Controlled Trial

This is a multicentre, parallel-group, open-label, pragmatic, randomised-control trial of early lifestyle intervention versus routine prenatal care by random allocation (1:1) in women with early abnormal glucose metabolism (EAGM) to compare the incidence of large-gestational age and preterm birth between two groups. We aim to assess the effectiveness of early lifestyle interventions and to provide evidence for the optimal standard management for Chinese women with EAGM.

开始日期2025-01-01

申办/合作机构

中山大学附属第一医院

[+5]

NCT06713421

/ RecruitingN/AIIT

The Effects of Premedication With Pronase and Postural Exercise on Mucosal Cleanliness During Painless Esophagogastroduodenoscopy: A Prospective, Multicenter, Randomized Controlled Study Based on Artificial Intelligence Assessment

Gastric cancer and esophageal cancer are common malignant tumors that threaten people's life and health. Esophagogastroduodenoscopy (EGD) is an important tool for screening upper gastrointestinal tumors, especially early tumors, and an effective method for detecting other upper gastrointestinal lesions, including ulcers and polyps. However, during EGD examination, mucus and foam can reduce the cleanliness of the mucosa and limit the operator's visual field, resulting in missed lesions and misdiagnosis. Previous studies have shown that preoperative medication with pronase and dimeticone is correlated with the improvement of upper gastrointestinal mucosal cleanliness. However, the number of samples in such studies is limited, and the artificial judgment is not objective enough to evaluate the cleanliness of upper digestive tract mucosa. And, whether a postural exercise is necessary for premedication with pronase or dimeticone remains unclear. Our team design this experiment to examine the efficacy of using premedication of dimeticone/pronase with a postural exercise on visualization of the mucosa before painless EGD. The investigators aim to provide new evidence to optimize the use of premedication with EGD.

开始日期2024-12-01

申办/合作机构

海军军医大学第一附属医院

[+25]

100 项与粤北人民医院相关的临床结果

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0 项与粤北人民医院相关的专利（医药）

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项与粤北人民医院相关的文献（医药）

2025-07-01·Cellular Signalling

LncRNA AC100865.1 regulates macrophage adhesion and ox-LDL intake through miR-7/GDF5 pathway

Article

作者: Chen, Jinfeng ; Chen, Baofeng ; Liu, Xiangying ; Liu, Xiangyang ; Liang, Jiarong ; Chen, Yunxian ; Ren, Yong

OBJECTIVESCardiovascular disease (CVD) accounts for over 40 % of deaths related to diseases among residents. Atherosclerosis (AS) and its associated thrombosis are the primary causes of CVD. LncRNA AC100865.1, a newly identified lncRNA, has shown potential as a diagnostic biomarker for AS. This study aims to evaluate the therapeutic value of lncRNA AC100865.1 in AS.METHODSReal-time PCR was conducted to assess the relative expression of lncRNA AC100865.1 in Peripheral Blood Mononuclear Cell (PBMC) samples from 50 CVD patients and 50 healthy controls. lncRNA AC100865.1 was overexpressed in RAW264.7 cells to measure its effects on adhesion and oxidized low-density lipoprotein (ox-LDL) uptake. Flow cytometry was utilized to identify the pathway mediating these processes. The luciferase assay and knockout rescue experiments were performed to elucidate the downstream signaling pathways involved.RESULTSlncRNA AC100865.1 expression was found to be downregulated in CVD patients. Overexpression of lncRNA AC100865.1 significantly enhanced the adhesion capacity of RAW264.7 cells. Luciferase reporter assays and flow cytometry indicated that this effect is mediated through the miR-7/GDF5/p38/LFA-1 pathway. Furthermore, lncRNA AC100865.1 notably increased ox-LDL uptake by macrophages via upregulation of CD36 expression.CONCLUSIONOverexpression of lncRNA AC100865.1 enhances the adhesion of RAW264.7 cells through the miR-7/GDF5/p38/LFA-1 pathway and increases ox-LDL uptake by elevating CD36 levels. These findings suggest that circulating lncRNA AC100865.1 may serve not only as an early diagnostic marker for CVD but also as a potential therapeutic target, offering new prospects for CVD treatment.

2025-04-21·Cancer Research

Abstract 4686: Efficacy and safety of efbemalenograstim alfa as primary prophylaxisfor concurrent chemo-radiotherapy induced neutropenia

作者: Li, Qiwen ; Wen, Zunbei ; Huang, Rong ; Chen, Yuanyuan ; Zhang, Xuefang ; Ji, Yongling ; Wang, Chen ; Lai, Shuzhen ; Chen, Ming ; Ouyang, Yi ; Li, Minying

Background:Concurrent chemo-radiotherapy (CCRT) occupies a pivotal position in the therapeutic management of various malignant tumors and frequently causes significant hematologic toxicity, particularly leukopenia and neutropenia. Nonetheless, granulocyte-macrophage colony-stimulating factor (GM-CSF) is not recommended for preventing CCRT, while granulocyte colony-stimulating factor (G-CSF) is seldom investigated in this setting. This study aims to evaluate the effectiveness and safety of efbemalenograstim alfa, a novel long-acting G-CSF, as a primary prophylaxis during CCRT.Method:This multicenter, open-label, randomized controlled trial will enroll 120 patients who are scheduled to undergo definitive CCRT for malignancies, including non-small cell lung cancer, small cell lung cancer, esophageal cancer, nasopharyngeal carcinoma, head and neck squamous cell carcinoma, or cervical cancer. Patients will be randomized 1:1 to study group or control group. In the study group, patients will receive efbemalenograstim alfa approximately 48 hours post-chemotherapy. In the control group, patients will receive rhG-CSF upon an absolute neutrophil count (ANC) drop below 1.0 × 109/L. Patients who developed febrile neutropenia (FN) or dose-limiting neutropenic event in the control group will receive efbemalenograstim alfa in the subsequent chemotherapy cycles. The primary endpoint is the incidence of 3/4 grade neutropenia (ANC < 1.0 × 109/L) throughout the CCRT period.Result:Efbemalenograstim alfa administration significantly reduced the incidence of grade 3/4 neutropenia during the CCRT period. Four patients (12.90%) in the efbemalenograstim alfa group experienced grade 3/4 neutropenia, compared to 14 (45.16%) in the control group, resulting in a difference of -32.26% (90% CI: -49.20%, -13.66%, p= 0.0035). The incidence of grade 3/4 neutropenia was 9.68% (study group) vs 45.16% (control group) (p=0.0009) across first chemotherapy cycle, and 3.23% (study group) vs 16.13% (control group) (p=0.0881) across second cycle. Efbemalenograstim alfa administration also resulted in shorter duration of grade 3/4 neutropenia, with a median duration of 0 day (IQR: 0-0) in study group and 0 day (IQR: 0-5) in control group (p=0.008). The depth of ANC nadir is higher in study group than that in control group (3.19 (0.26-8.45) × 109/L vs 1.00 (0.06-4.43) × 109/L, p < 0.001), the mean difference was 2.10 (1.39, 2.71) × 109/L. Efbemalenograstim alfa was well-tolerated, as no≥3 grade treatment-related adverse event (TRAE) was reported in both group. The most common treatment-emergent AEs in study group included thrombocytopenia (48.39%), anemia (45.16%) and hypokalemia (35.48%).Conclusion:Primary prophylaxis with efbemalenograstim alfa provide effective neutrophil support to patients undergoing CCRT, with good safety.Citation Format:Yuanyuan Chen, Qiwen Li, Zunbei Wen, Yi Ouyang, Shuzhen Lai, Rong Huang, Minying Li, Xuefang Zhang, Yongling Ji, Chen Wang, Ming Chen. Efficacy and safety of efbemalenograstim alfa as primary prophylaxisfor concurrent chemo-radiotherapy induced neutropenia [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 4686.

2025-04-01·Cancer Cell

Neoadjuvant toripalimab plus nimotuzumab combined with taxol-based chemotherapy in locally advanced penile squamous cell carcinoma

Article

作者: Lei, Yong Hong ; Sheng, Xi Nan ; Chen, Nan Hui ; Hu, Zhi Quan ; Xie, Qun ; Liu, Ting Yu ; Shi, Ben Kang ; Ma, Hua Li ; Liang, Pei Yu ; Li, Ji Bin ; Li, Yong Hong ; Han, Hui ; Li, Zai Shang ; Liu, Zhuo Wei ; Spiess, Philippe E ; Xiong, Long Bin ; Luo, Guang Heng ; Li, Xiang ; Xue, Ting ; Yan, Ru ; Cao, Zheng Guo ; Chen, Xiao Feng ; Xue, Cong ; Zhang, Ying Chun ; Chen, Mei Ting ; Shi, Yan Xia ; Luo, Jie Xin ; Qi, Lin ; Yao, Kai ; Zhou, Fang Jian ; An, Xin ; Xu, Wen Feng ; Zhang, Zhi Ling ; Liu, Zhi Zhong ; Dong, Pei ; Guo, Sheng Jie

The conventional neoadjuvant chemotherapy regimen for locally advanced penile squamous cell carcinoma (La-PSCC) has shown moderate response rates and survival benefits. This single-arm, phase II trial (NCT04475016) evaluated a neoadjuvant regimen of four cycles of toripalimab (anti-PD-1 antibody), nimotuzumab (anti-EGFR antibody), and taxol-based chemotherapy (TNT), followed by consolidative surgery. The primary endpoint was the pathological complete response (pCR) rate. Among 29 enrolled patients, 24 (82.8%) underwent consolidative surgery, with 14 (48.3%, 95% confidence interval [CI], 29.4-67.5%) achieving pCR. The objective response rate (ORR) was 82.8% (95% CI, 64.2-94.2). Median follow-up was 39.97 months, with two-year overall survival (OS) and progression-free survival (PFS) rates of 72.4% and 65.5%. Grade 3-4 treatment-related adverse events (TRAEs) occurred in 12 (41.4%) patients, with no treatment-related deaths. Biomarker analysis identified PD-L1 expression, TP53 mutation status, and CD8⁺ T cell density as potential predictive markers. Therefore, neoadjuvant TNT shows promising anti-tumor activity and acceptable toxicity.

项与粤北人民医院相关的新闻（医药）

2024-12-16

·生物世界

《美国医学会杂志》首次发表中国乳腺癌新药研究，复旦大学邵志敏教授领衔，卡瑞利珠单抗+化疗显著提高病理完全缓解率

撰文丨王聪编辑丨王多鱼排版丨水成文早期或局部晚期的三阴性乳腺癌（TNBC）的首选新辅助治疗策略包括蒽环类、环磷酰胺、紫杉烷类和铂类的四药化疗方案。阻断PD-1/PD-L1通路可能提高经典新辅助化疗的疗效。卡瑞利珠单抗（Camrelizumab）是由恒瑞医药开发的一款人源化的IgG4-κ抗PD-1单克隆抗体，已在晚期三阴性乳腺癌中显示出抗肿瘤活性。那么，在化疗的基础上联合使用卡瑞利珠单抗作为早期或局部晚期三阴性乳腺癌患者的新辅助治疗，可否提高病理完全缓解率？ 2024年12月13日，国际四大医学期刊之一的《美国医学会杂志》（JAMA）发表了题为：Camrelizumab vs Placebo in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-Negative Breast Cancer：The CamRelief Randomized Clinical Trial 的临床研究论文。这是首次对早期或局部晚期三阴性乳腺癌（TNBC）术前白蛋白紫杉醇＋铂类＋蒽环类＋环磷酰胺联合中国原创免疫治疗新药卡瑞利珠单抗（Camrelizumab）或者安慰剂的有效性和安全性进行双盲随机对照的临床试验。据悉，这也是《美国医学会杂志》创刊141年以来首次发表中国乳腺癌原创新药研究。在这项纳入了441例早期或局部晚期的三阴性乳腺癌患者的随机对照临床试验中，与安慰剂+化疗相比，卡瑞利珠单抗+化疗显著提高了患者的病理完全缓解率（56.8% vs 44.7%）。该全国多中心安慰剂双盲随机对照三期临床研究于2020年11月25日至2023年5月12日从中国40家医院入组高风险早期或局部晚期三阴性乳腺癌患者441例（中位年龄48岁）按1比1随机分为两组，为了评估卡瑞利珠单抗联合化疗与安慰剂联合化疗作为早期或局部晚期的三阴性乳腺癌新辅助治疗的疗效和不良反应。研究团队开展了一项全国多中心、安慰剂、双盲、随机对照的三期临床试验，在2020年11月25日至2023年5月12日从中国40家医院入组了高风险早期或局部晚期的三阴性乳腺癌患者441例（中位年龄48岁），然后按1:1随机分为两组，其中222例给予卡瑞利珠单抗＋化疗，其余219例给予安慰剂＋化疗。化疗包括前16周每28天的第1、8和15天给予白蛋白紫杉醇＋卡铂，随后8周每2周给予表柔比星＋环磷酰胺。主要研究终点为病理完全缓解（即术后病理检查乳腺和淋巴结都找不到浸润癌）。在随机分组的441名女性（中位年龄，48岁）中，从随机分组算起的中位（范围）随访时间为14.4个月。从随机分组算起，中位随访时间为14.4个月。结果显示，卡瑞利珠单抗-化疗组的126例患者（56.8%）和安慰剂-化疗组98例患者（44.7%）达到了病理学完全缓解。在新辅助治疗阶段，卡瑞利珠单抗-化疗组198例患者（89.2%）和安慰剂-化疗组182例患者（83.1%）发生了3级或更高级别的不良事件。卡瑞利珠单抗-化疗组77例患者（34.7%）和安慰剂-化疗组50例患者（22.8%）发生了严重不良事件，其中卡瑞利珠单抗-化疗组2例患者（0.9%）发生了致死性不良事件。总的来说，这项临床试验结果表明，在早期或局部晚期的三阴性乳腺癌患者中，新辅助化疗联合卡瑞利珠单抗，显著改善了患者的病理完全缓解。复旦大学附属肿瘤医院邵志敏、范蕾为论文共同通讯作者，复旦大学附属肿瘤医院陈力、四川省肿瘤医院李卉、南阳市中心医院张浩、广西医科大学附属肿瘤医院杨华伟、蚌埠医学院第一附属医院钱军、南昌市第三医院李志华、西安交通大学第一附属医院任予、北京大学人民医院王殊、浙江大学医学院附属第一医院傅佩芬、浙江省肿瘤医院杨红健、河北医科大学第四医院刘运江、安阳市肿瘤医院孙静、云南省肿瘤医院聂建云、粤北人民医院雷睿文、南京鼓楼医院姚永忠、广东省妇幼保健院张安秦、中南大学湘雅医院王守满、安徽省立医院马小鹏、厦门大学附属第一医院欧阳忠、遂宁市中心医院杨宏伟、复旦大学附属肿瘤医院吴松阳、曹朔文、王中华、广东省人民医院王坤、昆明医科大学第一附属医院蒋爱梅、湖南省肿瘤医院欧阳取长、哈尔滨医科大学附属肿瘤医院庞达、河南科技大学第一附属医院卫利民、江苏省人民医院查小明以及江苏恒瑞医药朱晓宇等人。论文链接： https://jamanetwork.com/journals/jama/fullarticle/2828232 设置星标，不错过精彩推文开放转载欢迎转发到朋友圈和微信群微信加群为促进前沿研究的传播和交流，我们组建了多个专业交流群，长按下方二维码，即可添加小编微信进群，由于申请人数较多，添加微信时请备注：学校/专业/姓名，如果是PI/教授，还请注明。点在看，传递你的品味

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100 项与粤北人民医院相关的药物交易

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100 项与粤北人民医院相关的转化医学

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