Personalized Tumor Neoantigen MRNA Therapy for Advanced Pancreatic Cancer.

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University

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

Sponsors and collaborators

Zhejiang University

Lead sponsor

First Affiliated Hospital of Zhejiang University

Sponsor institution

Hangzhou Neoantigen Therapeutics Co., Ltd.

Collaborator