The efficacy of biological therapy is very different from the efficacy characteristics of these traditional therapies. The evaluation of the efficacy of tumor immunotherapy is completely different from the evaluation of the efficacy of chemotherapeutic drugs, especially that it often takes several months, 4–8 months or even longer for the body to produce clinically measurable anti-tumor effects after biological therapy before the survival effects appear; the design of clinical trials and the statistical methods of survival analysis also need to be improved accordingly. . A variety of methods have been established for detecting immune responses in patients, which are mainly divided into two types of assays: specific and non-specific immune responses. Specific immune response monitoring methods include: the presence of antigen-specific T cells in patients after treatment by the delayed hypersensitivity reaction method; the number of specific T cells by ELISPOT and MHC-peptide complex tetramer method; and the function of antigen-specific T cells by detecting the in vitro killing activity of peripheral blood lymphocytes. Detection methods for non-specific immune responses include flow cytometry for peripheral blood lymphocyte subsets and ELISA for serum cytokine secretion levels. Therefore, there is no unified standard for the efficacy of tumor immunotherapy. Here, we propose suitable efficacy indicators for evaluating tumor immunotherapy with more expert consensus, in order of importance as follows: 1. overall survival (OS), progression-free survival (PFS); 2. imaging findings (at 3, 6, and 9 months); 3. changes in serum tumor markers (at 1, 2, 4, and 8 months); 4. patient symptoms, quality of life, and Karlson score (at 1, 2, 4, and 8 months). April, August). 5. Immunological indicators. There is a lack of quality control methods that can be used as a gold standard, limiting the use of T-cell response as an evaluation indicator for immunotherapy and the analysis of its correlation with clinical efficacy. Currently several immunological indicators are adopted as evaluation indicators.