| HRA007281
(Controlled Access)
|
This is a study of personalized neoantigen peptide vaccine for the treatment of solid tumors.The primary objective of the study is to determine the safety and tolerability of neoantigen peptide vaccines. The secondary objective is to evaluate the efficacy of neoantigen peptide vaccines and assess the change in immune response in the peripheral blood during and after the end of injection of the neoantigen peptide vaccines.The primary endpoint was the safety of the neoantigen peptide vaccine, focusing on adverse events. Secondary endpoints were vaccine efficacy: Overall survival and relapse-free survival. The study included screening period, treatment period and visit period. Subjects received a total of 7 doses of individualized peptide vaccine on day1(the day of the first dose),4,8±1,15±1,and day22±1.The 6th dose on 12±1 week after the first dose and the 7th dose on 20±1 week. Regular visits were performed at 8±1 weeks, 16±2 weeks, and 24±2 weeks. Survival follow-up was conducted every 12±2 weeks. |
