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Trial Title:
Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer
NCT ID:
NCT06344156
Condition:
Pancreatic Cancer
Adjuvant Therapy
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Pancreatic Cancer
Neoantigen
Adjuvant therapy
Safety
Clinical efficacy
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy
Description:
Gemcitabine +capecitabine, tislelizumab, neoantigen vaccines
Arm group label:
Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy
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
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhong Wu, MD
Phone:
028-85422851
Email:
wuzhong5555@126.com
Investigator:
Last name:
Zhong Wu
Email:
Principal Investigator
Start date:
April 1, 2024
Completion date:
April 1, 2027
Lead sponsor:
Agency:
Sichuan University
Agency class:
Other
Source:
Sichuan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06344156
