The purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 with standard adjuvant therapy in subjects with surgically resected digestive system neoplasms.
Male or female, >/= 18 years old and </= 75 years old, with the ability to understand and provide signed and witnessed informed consent, and agree and are able to comply with protocol requirements.
Subjects must have one of the histologically- or cytologically-confirmed advanced (locally advanced or metastatic) digestive system neoplasms listed below that can be radical resected. Subjects must be able to receive at least 4 cycles of standard adjuvant therapy according to CSCO clinical guidelines after surgery. The toxic effects of previous anti-tumor treatments have returned to </= grade 1 defined by NCI-CTCAE v5.0 or to the level specified by the inclusion/
Expected survival >/= 6 months.
ECOG performance status score of 0 ~ 1.
Sufficient tumor tissue samples can be obtained from subjects for genetic analysis, with at least 0.5cm*0.5cm of tissue required for surgical samples.
Echocardiographic evaluation: left ventricular ejection fraction (LVEF) >/= 50%.
Single group
iNeo-Vac-R01 in combination with standard adjuvant therapy
Biological/VaccinePersonalized mRNA vaccine encoding neoantigen, IH injection
Number of Participants with Adverse Events (AEs) [safety and tolerability]
Overall Survival (OS)
OS is defined as time between the date of the first dose of iNeo-Vac-R01 and the date of death due to any cause.
Recurrence Free Survival (RFS)
RFS is defined as time between the date of first dose of iNeo-Vac-R01 and the date of either disease recurrence or death (whichever is sooner).
The proportion of subjects who have no disease recurrence at 12 months or 24 months after first dose of iNeo-Vac-R01.
Neoantigen-specific T Cell Response [immunogenicity]
Detect the level of specific TNF-γ in peripheral blood of subjects by ELISpot in order to measure the neoantigen-specific T cell response of subjects.
Click on the lead sponsor to view all of their trials.
Sir Run Run Shaw Hospital
Lead sponsor
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborator
