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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
individualized anti-tumor new antigen iNeo-Vac-R01 injection
Biological/VaccineThe 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.
mFOLFIRINOX Treatment Regimen
Drugcontinuous intravenous infusion of fluorouracil 2400mg / m², for 46 hours, leucovorin 400mg / m², irinotecan 135mg / m², and oxaliplatin 68mg / m², every 2 weeks
Sintilimab injection
DrugSintilimab Injection, 200mg, intravenous infusion, every 3 weeks
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Arm AExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
Overall survival (OS)
The time from enrolled to death from any cause during the whole study
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhejiang University
Lead sponsor
First Affiliated Hospital of Zhejiang University
Sponsor institution
Hangzhou Neoantigen Therapeutics Co., Ltd.
Collaborator
Source ClinicalTrials.gov
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