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Clinical Trial Record

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Personalized Tumor Neoantigen MRNA Therapy for Advanced Pancreatic Cancer.

2025-04-01

2027-04-01

2028-04-01

30

Study Overview

Personalized Tumor Neoantigen MRNA Therapy for Advanced Pancreatic Cancer.

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.

N/A

  • Pancreatic Cancer Metastatic
  • Pancreatic Cancer Non-resectable
  • BIOLOGICAL: individualized anti-tumor new antigen iNeo-Vac-R01 injection
  • DRUG: mFOLFIRINOX Treatment Regimen
  • DRUG: Sintilimab injection
  • CISPD-10

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2025-03-15  

N/A  

2025-03-15  

2025-03-15  

N/A  

2025-03-21  

2025-03-21  

N/A  

2025-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Arm A

On D1 patients start the mFOLFIRINOX every 2 weeks, and the actual number of cycles of mFOLFIRINOX will be determined by the investigators according on the patients' physical condition, disease progression, adverse effects; on the same day, started S

BIOLOGICAL: individualized anti-tumor new antigen iNeo-Vac-R01 injection

  • The 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 studie

DRUG: mFOLFIRINOX Treatment Regimen

  • continuous intravenous infusion of fluorouracil 2400mg / m², for 46 hours, leucovorin 400mg / m², irinotecan 135mg / m², and oxaliplatin 68mg / m², every 2 weeks

DRUG: Sintilimab injection

  • Sintilimab Injection, 200mg, intravenous infusion, every 3 weeks
Primary Outcome MeasuresMeasure DescriptionTime Frame
Occurence and frequence of AE and SAEOccurence and frequence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)Up to 2 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Objective reponse rate (ORR)The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during the whole studyUp to 2 years
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.Up to 2 years
Progression-free survival （PFS）The time from enrolled to disease pregression or death from any cause during the whole study.Up to 2 years
Overall survival (OS)The time from enrolled to death from any cause during the whole studyUp to 2 years
Progression-free survival Rate（1-Y-PFS%, 2-Y-PFS%,3-Y-PFS%）The proportion of patients free from disease progression or death (whichever occurs first) at 12, 24, and 36 months.Up to 3 years
Overall Survival Rate (1-Y-OS%,2-Y-OS%,3-Y-OS%)The percentage of patients surviving at 12, 24, and 36 months.Up to 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Tingbo Liang, MD., PhD.

Phone Number: +8619941463683

Email: liangtingbo@zju.edu.cn

Study Contact Backup

Name: Yiwen Chen, MD.

Phone Number: +8615088682641

Email: yiwenchen0705@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    (1) Subjects who meet all the following entry criteria enter the pre-screening phase of the study:
    1. Voluntary signing of the informed consent form; 2. Age: 18 and 75 years old, male or female; 3. Evaluation as metastatic pancreatic cancer or postoperative recurrence according to the 2024 NCCN guidelines; 4. No systemic treatment, or disease progression with gemcitabine-based first-line chemotherapy. 5. An Eastern Cooperative Oncology Group (ECOG) physical fitness status score of 0 or 1; 6. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1); 7. Can obtain sufficient fresh tumor tissue samples for exome and transcriptome sequencing analysis; 8. Main organ function of heart, liver and kidney is normal: 9. Ferproductive men and women of childbearing age agree to take effective contraception from the date to the last dose of test drug; women of childbearing age included premenopause and women within 2 years after menopause; 10. Ability to follow the study protocol and follow-up procedures.
    (2) Subjects who meet all the following enrollment criteria enter the formal screening stage of the study and enter the study medication process:
    1. Voluntary signing of the informed consent form; 2. Age: 18 and 75 years old, male or female; 3. Pancreatic ductal adenocarcinoma (PDAC) diagnosed by pathology (histology or cytology); 4. No systemic treatment or gemcitabine-based first-line chemotherapy. 5. An Eastern Cooperative Oncology Group (ECOG) physical fitness status score of 0 or 1; 6. Main organ function of heart, liver and kidney is normal: 7. Ferproductive men and women of childbearing age agree to take effective contraception from the date to the last dose of test drug; women of childbearing age include premenopause and women within 2 years after menopause; 8. Ability to follow the study protocol and follow-up procedures.
    Exclusion Criteria:
    Subjects will be excluded from this study if they meet any of the following criteria:
    1. Pancreatic cancer has central nervous system metastasis or meningeal metastasis; 2. 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; 3. History of bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation; 4. 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; 5. Active bacterial or fungal infection identified by clinical diagnosis; a history of active TB or tuberculosis; 6. Patients with positive human immunodeficiency virus (HIV) antibody, positive treponema pallidum for syphilis (TP) antibody, active hepatitis C (positive hepatitis C virus (HCV) antibody and positive HCV RNA result), active hepatitis B; 7. Herpesvirus infection (except those who scab for more than 4 weeks); respiratory virus infection (except those who have recovered for more than 4 weeks); 8. Uncontrolled complications include but are not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia; severe coronary artery disease or cerebrovascular disease, or other diseases considered unacceptable by the investigator; 9. Previous history of drug abuse, clinical or psychological or social factors affecting informed consent or study implementation; a history of mental illness; 10. Patients with a history of food, drug or vaccine allergy or other potential immunotherapy allergies as considered by the Investigator. 11. Women born during pregnancy or lactation; 12. The investigator is not fit for enrollment or may not complete the trial for other reasons.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Hangzhou Neoantigen Therapeutics Co., Ltd.
  • : ,

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

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