Gastric Cancer Clinical Trial
Official title:
Phase I/II Study of DC Vaccine Targeting MG-7 Antigen to Treat Gastric Cancer
The primary purpose of the study is to determine the safety and efficacy of autologous DC vaccine in patients with later stage of gastric cancer. The DC vaccine is gene modified with gastric cancer specific antigen MG-7.
All eligible patients will receive two cycles of treatment, every 21 days is a treatment
cycle. The follow-up time will start from the next day after the end of the second cycle of
treatment, and last for 48 ±1 weeks (the follow-up time is 4 weeks, 12 weeks, 24 weeks, 36
weeks, 48 weeks). During the treatment and follow-up period, if disease progression or
intolerable side effects develop, the patient can voluntarily request to be withdrawn from
the study, or the investigators can determine that the patient be removed from the study.
DC and CTL are immune cells. PD-1 monoclonal antibody is an immune checkpoint inhibitor.
According to the relevant experience of similar cells or drugs, some patients may have
delayed or early pseudo-tumor progression after receiving immunotherapy, which needs to be
judged by investigators.
In this study, the screening period is no more than 14 days. After the screening examination
and evaluation, the eligible patients will enter the treatment period. The treatment and
follow-up are carried out according to the procedure. The follow-up period: tumor imaging
evaluation and related clinical indicator evaluation are carried out at the 4th week (± 1
week), the 12th week (± 1 week), the 24th week (± 1 week), the 36th week (± 1 week) and the
48th week (± 1 week) after the treatment. The patients should also complete the corresponding
safety inspection and evaluation before leaving the group. During the follow-up period, the
patients who do not have disease progression but do leave the group should continue to be
evaluated according to the original frequency until the end of the follow-up period or the
start of other anti-tumor treatment.
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