BMJ Open 2022;12:e055742. doi:10.1136/bmjopen-2021-055742Open access long- term and sustained clinical results achieved by tumour immunotherapy. Wedén et al followed up for 10 years in patients with pancreatic cancer and found that survival was 20% (4/20) in patients treated with a k- RAS mutant neoantigen vaccine compared with 0% (0/87) in the control group.37 The study by Schreiber’s group high- lights the critical role of MHC- II in the presentation of neoantigens. MHC- II can induce the polarisation of Th1, promote the activation of CTL, and increase the antitu- mour ability of CTL.38 39 The personalised neoantigen vaccine based on high- throughput sequencing has the advantages of accurately identifying and killing tumour cells, which is expected to be an important breakthrough for vaccines towards clin- ical practice. As a specific target of immunotherapy, the antitumour effect of tumour neoantigens can only target tumour cells rather than normal tissues.40 The identifi- cation of neoantigens and the development of neoan- tigens vaccine may provide more options for clinical immunotherapy. It may become one of the effective ways to treat malignant tumours in the future. This trial will be able to evaluate the safety and efficacy of neoantigen therapy in genomic unstable advanced solid malignant cancer patients and reveal the potential immune effects of individualised neoantigen tumour peptides mixtures in cancer patients. ETHICS AND DISSEMINATION Research ethics approval This study has received approval from the Ethics Committee of Chongqing University Cancer Hospital on 21 November 2019 (207/2019). The study protocol, informed consent form and other submitted documents were reviewed and approved. Confidentiality During the clinical trial, subjects will be identified solely by means of their individual identification code. Trial data will be stored and encrypted in accordance with local data protection laws. Dissemination policy Regardless of the results of the research, the final data will be publicly released. After the data collection is completed (within 12 months of the end of the study), a report with the results of the research will be submitted in an appropriate open- access, peer- reviewed medical journal. Author affiliations 1Department of Phase I Clinical Trial Ward, Chongqing University Cancer Hospital, Chongqing, China 2Department of Anesthesiology, Chongqing University Cancer Hospital, Chongqing, China 3Department of Clinical Trial Center, Chongqing University Cancer Hospital, Chongqing, China 4Department of Oncology, Chongqing Hospital of Traditional Chinese Medicine, Chongqing, ChinaAcknowledgements This work was supported by Beijing Neoantigen Biotechnology in terms of technology. We acknowledge financial support from Special Project for Performance Incentive and Guidance of Scientific Research Institutions of Chongqing, China grant to LW and XC, Beijing Municipal Science and Technology Commission to YMZ, and Natural Science Foundation and Science and Technology Bureau joint Health Bureau of Chongqing, China grant to JXT. We also thank the patient advisers for their efforts throughout the study. Contributors LW, JT, XC, WT, JZ and BL developed and planned this trial, and WN is the principal investigator of the study. LW performed basic research and wrote the manuscript. JT is responsible for statistical planning and statistical analysis. All authors read and approved the final manuscript. Funding The trial is sponsored by Special Project for Performance Incentive and Guidance of Scientific Research Institutions of Chongqing, China (cstc2019jxjl130029), Special Project for Performance Incentive and Guidance of Scientific Research Institutions of Chongqing, China (cstc2018jxjl130057), Science and Technology Bureau joint Health Bureau, Chongqing, China (2021MSXM177), Beijing Municipal Science and Technology Commission (Z191100007619018), and Natural Science Foundation of Chongqing, China (cstc2019jcyj- msxmX0623). Competing interests None declared. Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research. Patient consent for publication Not applicable. Provenance and peer review Not commissioned; externally peer reviewed. Open access This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/ licenses/by/4.0/. ORCID iDs Ling Wang http://orcid.org/0000-0002-3329-6771 Jiaxi Tang http://orcid.org/0000-0001-5023-9173 REFERENCES 1 Heron M. Deaths: leading causes for 2017. Natl Vital Stat Rep 2019;68:1–77.