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Recruiting Phase 1 NCT06344156

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

Trial Parameters

Condition Pancreatic Cancer
Sponsor Sichuan University
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 43
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-04-01
Completion 2026-04-01
Interventions
Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy

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

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 ang

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