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Clinical Trial Record

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Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer

2024-04-01

2026-04-01

2027-04-01

43

Study Overview

Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer

The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in postoperative adjuvant treatment of Pancreatic Cancer

N/A

  • Pancreatic Cancer
  • Adjuvant Therapy
  • DRUG: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy
  • CHANT-231

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

2024-03-27  

N/A  

2025-02-25  

2024-03-27  

N/A  

2025-02-28  

2024-04-03  

N/A  

2025-02  

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: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy

(1)8 cycles of Gemcitabine +capecitabine (Gemcitabine d1,8 ,Capecitabine d1-14 q3w）；（2） two 200 mg intravenous dose of tislelizumab (d1,q3w)（3）five intravenous doses of neoantigen vaccines given as priming doses(d1,8,22,36,50）and two booster dose(d80,d110

DRUG: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy

  • Gemcitabine +capecitabine, tislelizumab, neoantigen vaccines
Primary Outcome MeasuresMeasure DescriptionTime Frame
18-month RFSdefined recurrence as new lesions on the basis of response evaluation criteria in solid tumours (v.1.1), and RFS from either the date of surgery (RFS) or from the date of the last neoantigen vaccine priming dose to the date of recurrence or death, whichever occurred first.through study completion, an average of 2 year
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]Defined by treatment-related adverse events as assessed by CTCAE v4.03 months after the last administration of neoantigen vaccine
Secondary Outcome MeasuresMeasure DescriptionTime Frame
18-month OSdefined OS from the date of surgery to the date of death.through study completion, an average of 3 year

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: zhong Wu, MD

Phone Number: 028-85422851

Email: wuzhong5555@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. Age ≥18 years and age ≤75 years. 2. ECOG score 0-1. 3. Patients with histologically confirmed pancreatic ductal adenocarcinoma, R0 resection, stage I-III, not receiving neoadjuvant therapy. 4. Adequate bone marrow and organ function: 5. Patients of childbearing potential must take appropriate precautions prior to enrollment and during the study. 6. Signed informed consent. 7. Ability to comply with the study protocol and follow-up.
    Exclusion Criteria:
    1. Received antitumor chemotherapy, radiation therapy, or immunotherapy within 2 weeks prior to first vaccination. 2. The patient has a history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or urothelial tumors (Ta and TIS), or other malignancies that have been treated with curative intent (at least 5 years prior to enrollment). 3. Uncontrollable comorbidities, including but not limited to active bacterial or fungal infections, symptomatic congestive heart failure, unstable angina, arrhythmias. 4. HIV infection or active hepatitis B (HBV DNA≥500IU/ml), hepatitis C. 5. Uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease, or other conditions deemed ineligible by the investigator. 6. Uncontrollable comorbidities, including but not limited to active bacterial or fungal infections, congestive heart failure, unstable angina, arrhythmias, etc; 7. Patients with autoimmune diseases or immunodeficiencies being treated with immunosuppressive drugs. 8. Pregnant or lactating women. 9. Vaccination with other preventive vaccines within 4 weeks before the first administration or planned during the study period, including within 8 weeks after the last vaccination. 10. Those who have had a severe allergic reaction to vaccines for other infectious diseases in the past. 11. Those who may be allergic to the investigational product or any of its excipients. 12. Substance abuse or inability to undergo immunotherapy due to clinical, psychological, or social factors. 13. Significant weight loss (≥10%) within 6 weeks prior to enrollment. 14. Any uncertain factors that may affect patient safety or compliance.

Collaborators and Investigators

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

    • PRINCIPAL_INVESTIGATOR: zhong Wu, MD, West China Hospital

    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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