美国肿瘤免疫药物临床试验进展

L. Wan, Ye Zhang
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引用次数: 0

摘要

恶性肿瘤是威胁人类健康的重要因素。随着分子生物学、免疫学和肿瘤学的不断发展,肿瘤免疫药物逐渐成为恶性肿瘤手术、放疗、化疗后抑制肿瘤的有效手段。美国作为肿瘤免疫药物开发的领先国家,具有丰富的临床试验实践经验和全面的临床试验考虑。因此,本文拟从临床试验替代终点、青少年肿瘤患者临床试验、多药物和/或多肿瘤亚组单一临床试验主方案设计等方面探讨美国肿瘤免疫药物临床试验的进展,为中国优化临床试验设计、扩大肿瘤免疫药物的应用范围提供参考。加快新药上市的进程。
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Progress in Clinical Trials of Tumor Immunodrugs in the United States
Malignant tumors are a key factor that threatens human health. With the continuous development of molecular biology, immunology and oncology, tumor immunodrugs have gradually become an effective means to suppress malignant tumors after surgery, radiotherapy and chemotherapy. The United States, as a leading country in the development of tumor immunodrugs, has rich clinical trial practice experience and comprehensive clinical trial considerations. Therefore, this article intends to explore the progress of clinical trials of tumor immunodrugs in the United States in terms of the alternative endpoints of clinical trials, clinical trials of adolescent tumor patients, and the design of a single clinical trial main plan for multiple drugs and/or multiple tumor subgroups, thereby providing a reference for optimizing the design of clinical trials in China, expanding the application scope of tumor immunodrugs, and speeding up the process of marketing new drugs.
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