针对 HER2 表达性高风险非肌肉侵入性膀癌的静脉内迪西他马布维多丁 (RC48):单臂,剂量升级的第一阶段试验研究
Xu Chen1,2,3, Ming Huang1,2, Zehua Chen1,2
1Department of Urology Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou China.
MedComm
|July 15, 2025
概括
静脉注射的迪西他马布维多丁 (RC48) 对表达HER2的高风险非肌肉侵入性膀癌 (HR-NMIBC) 是有前途的. 这种新的治疗方法耐受性良好,并显示出初步的疗效,为改善结果提供了希望.
科学领域:
- 在瘤学瘤学.
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 临床试验 临床试验
背景情况:
- 在高危非肌肉侵入性膀癌 (HR-NMIBC) 中的HER2表达与对Bacillus Calmette-Guérin (BCG) 治疗的反应不佳有关.
- 对于表达HER2的HR-NMIBC,迫切需要新的肠道治疗方法.
研究的目的:
- 评估HER2表达HR-NMIBC的患者内静脉注射迪西塔马布维多丁 (RC48) 的安全性和耐受性.
- 评估初步的瘤结果,包括无复发生存率 (RFS) 和无进展生存率 (PFS).
主要方法:
- 一个单臂,I期临床试验 (ChiCTR2300073975) 涉及9名患有HER2表达HR-NMIBC的患者.
- 患者每周接受6周内静脉RC48 (60,120或180毫克剂量),然后随意每月维持剂量.
- 通过监测剂量限制性毒性 (DLT) 和与药物相关的不良事件 (AE) 来评估安全性.
主要成果:
- 所有9名患者完成了没有DLT或等级≥3药物相关副作用的诱导课程.
- 最常见的与药物相关的副作用是尿路感染 (55.6%),尿动频率 (11.1%),以及血 (11.1%).
- 在12个月后,RFS为87.5%,PFS为100%,表明有希望的瘤结果.
结论:
- 在HER2表达HR-NMIBC患者中,静脉内RC48是安全的,并且耐受性良好.
- 在复发和进展方面,RC48显示了初步的疗效.
- 进一步的剂量探索正在进行中,以确定最大耐受剂量并优化治疗方案.
更多相关视频
11:02Induction of Invasive Transitional Cell Bladder Carcinoma in Immune Intact Human MUC1 Transgenic Mice: A Model for Immunotherapy Development
Published on: October 30, 2013
21.4K
06:15Tumor Treating Field Therapy in Combination with Bevacizumab for the Treatment of Recurrent Glioblastoma
Published on: October 27, 2014
27.5K
相关概念视频
02:56Treatment Resistant Cancers
3.4K
Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
3.4K
01:30Urinary Tract Calculi III: Medical Management
27
The diagnosis of renal calculi involves several imaging techniques, including non-contrast CT scans and ultrasound. These methods help visualize kidney stones, assess their size and location, and detect possible obstructions. Additionally, Measuring urine pH is useful for diagnosing specific stone types, such as struvite (alkaline pH) and uric acid stones (acidic pH). Cystine stones are primarily linked to cystinuria, a genetic condition. A urinalysis helps detect blood in the urine (hematuria)...
27
01:17Drugs for Treatment of Diarrhea-Predominant IBS
303
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a subtype of IBS characterized primarily by frequent, loose, or watery stools, abdominal pain, and abdominal discomfort. Therapeutic approaches to managing IBS-D include dietary changes, stress management techniques, and pharmaceutical interventions.
Two specific drugs used in the treatment are alosetron (Lotronex) and eluxadoline (Viberzi). Alosetron, a 5-HT3 antagonist, works by slowing the movement of stools in the gut, reducing bowel...
Two specific drugs used in the treatment are alosetron (Lotronex) and eluxadoline (Viberzi). Alosetron, a 5-HT3 antagonist, works by slowing the movement of stools in the gut, reducing bowel...
303