The goal of this interventional clinical study is to learn the safety and preliminary efficacy of XH001 injection (Personalized mRNA tumor neoantigen vaccine) combined with standard adjuvant treatment in treating patients with high-risk recurrent solid tumors after radical surgery. The main questions it aims to answer are: What medical problems do participants have when using the combined treatment? Does XH001 injection combined with standard adjuvant treatment induce a specific T-cell response, and can it prolong the patient's relapse-free survival?
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
mRNA neoantigen cancer vaccine
oxaliplatin+lrinotecan+calcium folinate+5-FU
Peking Union Medical College Hospital
Beijing, China
RECRUITINGPeking University Cancer Hospital
Beijing, China
RECRUITINGAdverse Event
Incidence and severity of adverse events (AEs), clinically significant abnormal changes in laboratory tests and other examinations (based on the Criteria for the Evaluation of Adverse Events \[CTCAE\] v5.0)
Time frame: up to 36 months
Dose-Limiting Toxicity
Grade 3 or higher adverse events (AEs) or laboratory abnormalities related to XH001 injection
Time frame: From the first administration of XH001 to 4 weeks after the first administration of XH001 injection.
Immune response at different doses
Using in vitro ELISPOT and/or TCR-Clone track to verify the immunoreactivity of the peripheral blood lymphocytes from the subjects to the selected tumor neoantigens.
Time frame: From Baseline up to 2 years.
Recurrent-Free Survival
The time from the patient undergoing radical surgery to recurrence or death from any cause, whichever comes first.
Time frame: 3 years
Local Recurrent-Free Survival
The time from the patient undergoing radical surgery to local recurrence or death from any cause, whichever comes first.
Time frame: 3 years
Distant metastasis-Free Survival
The time from the patient undergoing radical surgery to distant metastasis or death from any cause, whichever comes first. If the patient has not developed metastasis by the end of the study, the last follow-up time will be the endpoint.
Time frame: 3 years
Overall survival
The time from the patient undergoing radical surgery to death from any cause.
Time frame: 3 years
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