致癌试验的目的是考察药物在动物体内的潜在致癌作用，从而评价其可能对人类的相关风险，是非临床药物安全性评价的主要内容之一。啮齿动物致癌试验的结果与人类安全性评估的相关性经常引起争议，可能需要做进一步的研究来探讨其作用方式，以帮助确定是否存在对人类的潜在致癌性。当啮齿动物致癌试验出现阳性结果时，可能需要进行进一步的毒性病理学研究探讨其作用机制，来评估与人类的相关性。简要介绍动物致癌试验结果与人类相关性的必要性、致癌试验基于作用方式与人类风险评估无关的肿瘤、致癌试验基于作用方式与人类风险评估可能无关的肿瘤，以期为我国非临床药物致癌试验的结果分析和药物评价研究提供一定参考。

The objective of carcinogenicity study is to identify the potential carcinogenesis in animals and to assess the relevant risks in humans of drugs, which is one of the major components of nonclinical safety evaluation of drugs. The relevance between the results of rodent carcinogenicity studies and assessment of human safety are often the cause for debate. Further toxicologic pathology research may be needed to investigate the mode of action, which contribute to confirm the presence or the lack of potential carcinogenesis for humans. When rodent carcinogenicity study shows positive results, further studies may be needed to investigate the mechanism of action to assess the correlation with humans. This article gives brief introduction of the need for evaluating the relevance between study results in animals and human safety in carcinogenicity study, some tumors in carcinogenicity study not relevant to humans, some tumors in carcinogenicity study possibly not relevant to humans based on mode of action, in order to provide some references for the result analysis of nonclinical carcinogenicity study and drug evaluation research in China.

江苏省新药一站式高效非临床评价公共服务平台建设项目（BM2021002）