Digestive System Neoplasms
Conditions
Brief summary
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.
Detailed description
This is a single-center, open-label, single-arm clinical study of personalized mRNA vaccine iNeo-Vac-R01 in combination with standard adjuvant therapy in subjects with surgically resected digestive system neoplasms.
Interventions
BIOLOGICALiNeo-Vac-R01 in combination with standard adjuvant therapy
Personalized mRNA vaccine encoding neoantigen, IH injection
Sponsors
Hangzhou Neoantigen Therapeutics Co., Ltd.
Sir Run Run Shaw Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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/
Exclusion criteria
. Subjects with any of the following digestive system neoplasms: a. Cholangiocarcinoma b. Pancreatic cancer c. Hepatocellular carcinoma d. Gastric cancer e. Colorectal carcinoma 3. Expected survival \>/= 6 months. 4. ECOG performance status score of 0 \ 1. 5. 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. 6. Echocardiographic evaluation: left ventricular ejection fraction (LVEF) \>/= 50%. 7. The organ function level must meet the following requirements: absolute neutrophil count (ANC) \>/= 1.5 × 10\^9/L, platelet count (PLT) \>/= 80 × 10\^9/L, hemoglobin (Hb) \>/= 90 g/L; serum total bilirubin (TBIL) \</= 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \</= 2.5 × ULN (if there is liver metastasis, TBIL \</= 3 × ULN, AST, ALT \</= 5 ×ULN are allowed), serum albumin \>/= 28g/L, serum creatinine \</= 1.5 × BUN, Glomerular filtration rate \>/= 50mL/min, prothrombin time (PT) and activated partial thromboplastin time (APTT) and international standardized ratio (INR) \</= 1.5 × ULN (without anticoagulant therapy) . 8. For women of childbearing potential: having a negative serum or urine pregnancy test within 7 days prior to study initiation, agreement to remain abstinent or use contraceptive measures during the treatment period. 9. For men: agreement to remain abstinent or use contraceptive measures during the treatment period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events (AEs) [safety and tolerability] | 21 days after last iNeo-Vac-R01 dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Free Survival (RFS) | 3 years after first dose of iNeo-Vac-R01 | 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. | 12 months and 24 months after first dose of iNeo-Vac-R01 | — |
| Overall Survival (OS) | 3 years after first dose of iNeo-Vac-R01 | 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. |
| T Cell Subsets [immunogenicity] | 12 months after first dose of iNeo-Vac-R01 | Detect the proportion of different T cell subsets in T cells by flow cytometry. |
| Cytokines Level [immunogenicity] | 6 months after first dose of iNeo-Vac-R01 | Record the changes of IL-2, IL-6, IL-8, IL-10, IL-12, and TNF-α in peripheral blood before and after treatment. |
| Neoantigen-specific T Cell Response [immunogenicity] | 12 months after first dose of iNeo-Vac-R01 | 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. |
Countries
China
Contacts
Primary ContactXiujun Cai
Outcome results
None listed