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Vaccines

Subjects will receive at least 4 cycles of standard first-line treatment according to Chinese Society of Clinical Oncology (CSCO) clinical guidelines. Then subjects will receive iNeo-Vac-R01 via IH injection on Day 1 of each 21-day cycle for up to 9 cycles at an applicable dose, identified during the dose escalation phase of the study.

Personalized mRNA vaccine encoding neoantigen, IH injection

iNeo-Vac-R01

Xiujun Cai, MD

The purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 in combination with first-line treatment in subjects with advanced digestive system neoplasms.

This is a single-center, open-label, single-arm clinical study of personalized mRNA vaccine iNeo-Vac-R01 in combination with first-line treatment in subjects with advanced digestive system neoplasms.

Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Combination With Standard First-line Treatment in Subjects With Advanced Digestive System Neoplasms

A Clinical Study to Assess the Safety, Feasibility, and Efficacy of Personalized mRNA Vaccine Encoding Neoantigen in Combination With Standard First-line Treatment in Subjects With Advanced Digestive System Neoplasms

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.

ORR is defined as proportion of subjects with complete response (CR) and partial response (PR) to all subjects based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

DCR is defined as proportion of subjects with reduced or stable neoplasms that have been maintained for a certain period of time, including the proportion of subjects with CR, PR, and stable disease (SD).

DOR is defined as time from first PR or CR until either disease progression or death (whichever is sooner).

PFS is defined as time between the date of first dose of iNeo-Vac-R01 and the date of either disease progression or death (whichever is sooner).

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.

Detect the proportion of different T cell subsets in T cells by flow cytometry.

Record the changes of IL-2, IL-6, IL-8, IL-10, IL-12, and TNF-α in peripheral blood before and after treatment.

Spots Global Cancer Trial Database for personalized mrna vaccine