About this trial
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.
Eligibility criteria
Qualifiers
Voluntary signing of the informed consent form;
Age: 18 and 75 years old, male or female;
Evaluation as metastatic pancreatic cancer or postoperative recurrence according to the 2024 NCCN guidelines;
No systemic treatment, or disease progression with gemcitabine-based first-line chemotherapy.
Disqualifiers
Pancreatic cancer has central nervous system metastasis or meningeal metastasis;
At the same time with other malignant tumors, but cured basal cell cancer, thyroid cancer, cervical dysplasia, etc., have been in the disease for more than 5 years or do not considered to be easy to relapse except;
History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation;
Patients with immunosuppressants, that is, those who require regular use of immunosuppressants 4 weeks before the screening period and the clinical study, including but not limited to the following conditions: severe asthma, autoimmune diseases or immune deficiency, treated with immunosuppressive drugs, and known history of primary immunodeficiency; except type 1 diabetes, autoimmune-related hypothyroidism requiring hormone therapy, vitiligo and psoriasis that do not require systemic therapy;
Trial design
Treatments tested in this trial
- individualized anti-tumor new antigen iNeo-Vac-R01 injection
- mFOLFIRINOX Treatment Regimen
- Sintilimab injection
Treatment groups
Sponsors and collaborators
Zhejiang University
Lead sponsor
First Affiliated Hospital of Zhejiang University
Sponsor institution
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborator