在局部晚期鼻癌中短期PD-1阻塞:II期随机试验方案 (Tori-013)
Hongyuan Jia1, Junchao Wang1, Ling Zhang2
1Department of Radiation Oncology, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China, Chengdu, China.
Frontiers in immunology
|September 3, 2025
概括
这项研究评估了局部晚期鼻癌 (LANPC) 的免疫治疗时间缩短. 这项试验旨在调查托利帕利马布与化疗和放射治疗相结合是否能改善LANPC患者的治疗结果.
科学领域:
- 癌症学
- 免疫疗法
- 临床试验
背景情况:
- 免疫疗法对局部晚期鼻癌 (LANPC) 具有前景.
- 对LANPC免疫治疗的最佳治疗持续时间和组合尚未确定.
- 鼻癌 (NPC) 仍然是一个重大的健康问题,特别是在晚期.
研究的目的:
- 评估与诱导化疗 (IC) 和并发化疗 (CCRT) 结合的缩短免疫治疗方案,用于III/ IVa鼻癌 (NPC).
- 评估toripalimab (抗PD-1抗体) 在LANPC新型免疫化学放射治疗策略中的有效性和安全性.
- 确定简化方法是否可以提高治疗结果,同时保持耐受性.
主要方法:
- 一个开放的,随机的,单盲的,多中心的II期试验 (Tori-013),估计涉及154名参与者.
- 患者被随机分配为接受IC (gemcitabine + cisplatin) 以及CCRT (cisplatin +放射治疗) 或托利帕利马布或安慰剂.
- 在IC和CCRT期间,托里帕利马布和安慰剂,以及放射治疗后的两个额外循环. 主要终点:无进展的3年生存期 (PFS).
主要成果:
- 这项研究仍在进行中,结果尚未公布.
- 关键的二次终点包括整体存活率 (OS),客观反应率 (ORR) 和爱斯坦- 巴尔病毒 (EBV) DNA和淋巴细胞子集的变化.
- 安全性评估重点是使用CTCAE v5.0标准的免疫相关不良事件 (irAEs).
结论:
- 这项试验旨在为局部先进的NPC建立一种新的,精简的免疫化学放射治疗策略.
- 这些发现可能会改善LANPC患者的疗效.
- 这项研究旨在平衡增强治疗效果与患者耐受性.
相关概念视频
Targeted Cancer Therapies
7.0K
The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against...
There are several types of targeted therapies against...
7.0K
Treatment Resistant Cancers
2.6K
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...
2.6K
Tumor Immunotherapy
2.5K
Immunotherapy is a treatment that boosts or manipulates the immune system to fight diseases, including cancer. For instance, by stimulating an immune response through vaccinations against viruses that cause cancers, like hepatitis B virus and human papillomavirus, these diseases can be prevented. Nonetheless, some cancer cells can avoid the immune system due to their rapid mutation and division. The immune response to many cancers involves three phases: elimination, equilibrium, and escape.
2.5K


