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Archive > Volume 23 Issue 6 > 2016,23(6):741-744. DOI:10.3872/j.issn.1007-385X.2016.06.001 Prev Next
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Key points and difficulties in clinical trials of cellular immunotherapy of cancer
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Abstract:
Cellular immunotherapy of cancer is an important approach of cancer immunotherapy which showed a bright prospect for practical application in clinical research. However, with the rapid development of cellular immunotherapy of cancer, it should be aware that the unique characteristics of the therapy have also brought new challenges and difficulties to the design and evaluation of clinical trials. Immune related response criteria (irRC) has been designed to better evaluate curative efficacy of the immunotherapies. In clinical trials, irRC as evaluation standards was widely used, and became a powerful tool in clinical research coordinating with traditional WHO or RECIST evaluation system. And it further offer more choices of clinical trial endpoints for the immunotherapy. In this review, based on the dual attributes of drug and technique for cellular immunotherapy, reagents and other materials used in collection, screen and process of immunocytes as well as key points of technics and product quality control and other aspects were summed up. Uniform technical specification and testing standardsused in multi-centers of clinical trials were also explored. It was sincerely hoped that more convincing evidences of multi-center randomized controlled clinical trials could be provided by workers of cancer celluar immunotherapy in China with continuous innovation, of the celluar immunotherapy, so then to promote vigorous development of the cellular immunotherapy in China.
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Project Supported:
Project supported by the National Science and Technology Support Program (No. 2015BAI12B12), and the National Natural Science Foundation for Youth Program (No. 81401888)
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