Adjuvant Therapy, Pancreatic Cancer
Conditions
Keywords
Pancreatic Cancer, Neoantigen, Adjuvant therapy, Safety, Clinical efficacy
Brief 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
Interventions
DRUGNeoantigen Vaccine Plus Anti-PD1 and Chemotherapy
Gemcitabine +capecitabine, tislelizumab, neoantigen vaccines
Sponsors
Sichuan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 18-month RFS | through study completion, an average of 2 year | 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. |
| Incidence of Treatment-Related Adverse Events [Safety and Tolerability] | 3 months after the last administration of neoantigen vaccine | Defined by treatment-related adverse events as assessed by CTCAE v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 18-month OS | through study completion, an average of 3 year | defined OS from the date of surgery to the date of death. |
Countries
China
Contacts
Primary Contactzhong Wu, MD
Outcome results
None listed