Carcinoma, Non-Small Cell Lung Clinical Trial
Official title:
A Phase I Study on the Safety and the Efficacy of Personalized Neoantigen-primed Dendritic Cell Vaccines for Refractory Lung Cancer
Various of immunotherapies are now widely applied in the treatment of lung cancer. Neoantigens arising from the mutations of the tumor genome expressed specifically on the tumor cell instead of normal cells, suggesting that vaccines targeting neoantigens should generate a highly tumor-specific response with minimal off-target effects. Neoantigens are highly suitable for the development of cancer vaccines. The study aims to evaluate the safety and efficacy of neoantigen-loaded dendritic cell (DC) vaccines for refractory lung cancer.
Cancer genome research has exploded benefits from the application of modern high-throughput
genome sequencing in the past few years. Since usually there are no common antigens expressed
on the surfaces of different kinds of tumors, neoantigens which expressed specifically in the
individual tumor are chosen to establish tumor-specific vaccines.
30 patients with refractory lung cancer would be enrolled and undergo tumor resection if all
requirements are met. The whole-exome sequencing and the bioinformatic analysis of the
resected specimens would be performed to identify the neoantigens. Then, candidate
neoantigens would be synthesized to pulse the matured DC cells. Neoantigen-primed DC vaccines
are provided to the corresponding patients. Each patient would be vaccinated 6 times in
total, one shot per week.
Patients enrolled would undergo the schemed follow-up, one time per three months. The side
effects, overall survival, and progress-free survival would be recorded. At the end of the
research, the safety and efficacy of neoantigen DC vaccines for refractory lung cancer would
be evaluated.
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