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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06344156
Other study ID # PDAC-Neoantigen
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date April 1, 2024
Est. completion date April 1, 2027

Study information

Verified date March 2024
Source Sichuan University
Contact zhong Wu, MD
Phone 028-85422851
Email wuzhong5555@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 43
Est. completion date April 1, 2027
Est. primary completion date April 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy
Gemcitabine +capecitabine, tislelizumab, neoantigen vaccines

Locations

Country Name City State
China West China Hospital, Sichuan University Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 18-month RFS defined 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
Primary Incidence of Treatment-Related Adverse Events [Safety and Tolerability] Defined by treatment-related adverse events as assessed by CTCAE v4.0 3 months after the last administration of neoantigen vaccine
Secondary 18-month OS defined OS from the date of surgery to the date of death. through study completion, an average of 3 year
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