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

30 Participants
are divided into 1 treatment group

Locations

1
First Affiliated Hospital of Zhejiang University Schlool of Medicine31000, HangzhouZhejiang, China

Sponsors and collaborators

Zhejiang University

Lead sponsor

First Affiliated Hospital of Zhejiang University

Sponsor institution

Hangzhou Neoantigen Therapeutics Co., Ltd.

Collaborator