针对肿瘤的治疗策略中，抗肿瘤免疫逃逸成为普遍关注的治疗手段，肿瘤免疫治疗成为快速发展的研究领域，特别是FDA批准肿瘤免疫细胞疫苗用于治疗前列腺癌、针对PD-1和CTLA-4单克隆抗体的成功上市。从2010年开始，国内肿瘤免疫细胞治疗研究迅速发展，围绕免疫细胞治疗临床工作的一些问题摆在面前。如何选择肿瘤免疫细胞治疗方法和时机？治疗过程中的质量管理和疗效评价应当怎么做？如何得到更有说服力的循证医学证据？都是值得深入探索的重要问题。肿瘤免疫细胞治疗临床研究中的质量管理和疗效评价与传统的生物药和化疗药相比，有共同点也有差别。质量管理涉及组织结构、人员培训、试验方案等多个环节。免疫细胞治疗的疗效评价不能简单套用传统实体瘤治疗的评价方法，国外学术界已经提出了一些免疫治疗评价标准，但还处在发展与完善的阶段。笔者通过对上述这些问题的讨论，希望能得到国内从事该领域临床研究和技术研发同行们的重视，只有在解决好这些问题的基础上不断前行，才能促进肿瘤生物治疗的不断发展，更好地服务于肿瘤患者。

Among the various available cancer treatment modalities, anti-tumor immune escape is attracting tremendous attention worldwide and has become one of the fast-developing research fields, especially when the anti-prostate cancer vaccine was approved by the FDA and the monocloan antibodies, which targeted PD-1 and CTLA-4, were successfully launched into market. Since 2010, tremendous research progress has been made on cellular immunotherapy of cancer in China. Nevertheless, practically cellular immunotherapy of cancer is facing several challenging issues. Including: 1) how to choose the proper treatment modality and time duration; 2) how to manage the quality control; 3) how to evaluate the treatment outcome; and 4) how to obtain stronger empirical evidence to support the benefits of the treatment. With regard to quality management and outcome evaluation, there exist similarities and differences between cellular immunotherapy and traditional biological and chemical drugs for cancers. Similar to the quality control of biological and chemical treatments of cancer, the quality management of cellular immunotherapy of cancer involves such aspects as the structure of the clinic or center, personnel training and testing program. In contrast, the outcome evaluation of cellular immunotherapy of cancer cannot simply follow the traditional method for biological and chemical cancer therapies. This paper aims to review the recent development in the quality management and outcome evaluation of cellular immunotherapy of cancer, hoping to bring these issues to the attention of peers in China.

国家高技术研究发展计划（863计划）资助项目（No.2013AA020103); 国家新药创制重大专项（No. 2011ZX09102-001）。