This study is a single-center, open-label clinical study to evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimen as adjuvant treatment for postoperative resectable pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
The individualized anti-tumor new antigen iNeo-Vac-R01 injection was commissioned by Hangzhou Neoantigen Therapeutics 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.
Gemcitabine: 1000 mg/m², administered intravenously over 30 minutes on Day 1 and Day 8; Capecitabine: 1650-2000 mg/(m²·day), divided into two daily oral doses from Day 1 to Day 14. Treatment cycles repeat every 3 weeks for 8 cycles, with the actual number of cycles determined by the investigator based on comprehensive evaluation of the patient's physical status, disease progression, and adverse reactions.
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
Recurrence-Free Survival (RFS)
Defined as the time from the date of surgery to the first occurrence of disease recurrence or death from any cause (whichever occurs first). Tumor recurrence is defined as the development of one or more new lesions, which may be local (at the primary site), regional (in adjacent lymph nodes or tissues), or distant (metastatic lesions remote from the original resection site).
Time frame: Up to 2 years
Recurrence-Free Survival Rate (RFS%)
The proportion of patients free from disease recurrence or death (whichever occurs first) at 12 months, 24 months, and 36 months following surgery.
Time frame: Up to 3 years
Overall Survival (OS)
Defined as the time from the date of surgery to death from any cause.
Time frame: Up to 4 years
Overall Survival Rate (OS%)
The proportion of patients surviving at 12 months, 24 months, and 36 months following surgery.
Time frame: Up to 3 years
Efficacy Evaluation Metrics for Patients with Recurrence: Objective Response Rate (ORR)
The proportion of patients achieving a partial response (PR) or complete response (CR) in tumor lesions, as defined by RECIST 1.1 criteria.
Time frame: Up to 3 years
Efficacy Evaluation Metrics for Patients with Recurrence: Disease Control Rate (DCR)
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Sintilimab Injection, 200mg, intravenous infusion, every 3 weeks
The proportion of patients achieving PR, CR, or stable disease (SD) in tumor lesions.
Time frame: Up to 3 years
Efficacy Evaluation Metrics for Patients with Recurrence: Progression-Free Survival (PFS)
Defined as the time from the date of initiating first-line chemotherapy to the first occurrence of disease progression or death from any cause (whichever occurs first).
Time frame: Up to 3 years
Efficacy Evaluation Metrics for Patients with Recurrence: Progression-Free Survival Rate (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
Efficacy Evaluation Metrics for Patients with Recurrence: Overall Survival (OS)
Defined as the time from the date of initiating first-line chemotherapy to death from any cause.
Time frame: Up to 4 years
Efficacy Evaluation Metrics for Patients with Recurrence: Overall Survival Rate (OS%)
The proportion of patients surviving at 12, 24, and 36 months.
Time frame: Up to 3 years