This study is a single-arm phase I/II clinical study to evaluate the effectiveness of evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimens for the treatment of patients with advanced pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The individualized anti-tumor new antigen iNeo-Vac-R01 injection was commissioned by Hangzhou Nuanjin Biotechnology Co., Ltd., and all patients were admitted into the therapeutic intervention group. According to the results of previous non-clinical studies, the individualized mRNA injection of 100 μ g was a tolerable dose.
continuous intravenous infusion of fluorouracil 2400mg / m², for 46 hours, leucovorin 400mg / m², irinotecan 135mg / m², and oxaliplatin 68mg / m², every 2 weeks
Sintilimab Injection, 200mg, intravenous infusion, every 3 weeks
First Affiliated Hospital of Zhejiang University Schlool of Medicine
Hangzhou, Zhejiang, China
Occurence and frequence of AE and SAE
Occurence and frequence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)
Time frame: Up to 2 years
Objective reponse rate (ORR)
The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during the whole study
Time frame: Up to 2 years
Disease control rate (DCR)
The proportion of patients who had tumor evaluated as PR or SD according to RECIST1.1 criteria during the whole study.
Time frame: Up to 2 years
Progression-free survival (PFS)
The time from enrolled to disease pregression or death from any cause during the whole study.
Time frame: Up to 2 years
Overall survival (OS)
The time from enrolled to death from any cause during the whole study
Time frame: Up to 2 years
Progression-free survival Rate(1-Y-PFS%, 2-Y-PFS%,3-Y-PFS%)
The proportion of patients free from disease progression or death (whichever occurs first) at 12, 24, and 36 months.
Time frame: Up to 3 years
Overall Survival Rate (1-Y-OS%,2-Y-OS%,3-Y-OS%)
The percentage of patients surviving at 12, 24, and 36 months.
Time frame: Up to 3 years
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